Ignite Creation Date:
2025-12-24 @ 4:33 PM
Ignite Modification Date:
2026-01-24 @ 10:39 PM
Study NCT ID:
NCT03738566
Status:
COMPLETED
Last Update Posted:
2023-05-24
First Post:
2018-11-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Alexander.Jeffrey14@mayo.edu', 'phone': '507-538-0474', 'title': 'Dr. Jeffrey A. Alexander', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from baseline to end of study for a total of approximately 12 months on all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Standard Clinical Care Endoscopic Dilation, Then ESDT', 'description': 'Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Esophageal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Endoscopic Interventions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'OG001', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.'}, {'id': 'OG002', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'OG003', 'title': 'Standard Clinical Care Endoscopic Dilation, Then ESDT', 'description': 'Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months following serial dilation', 'description': 'Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care', 'unitOfMeasure': 'endoscopies', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length of Days Intervention Free', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'OG001', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.'}, {'id': 'OG002', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '33'}, {'value': '82', 'groupId': 'OG001', 'lowerLimit': '39', 'upperLimit': '124'}, {'value': '147', 'groupId': 'OG002', 'lowerLimit': '113.5', 'upperLimit': '166.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'description': 'Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mayo Dysphagia Questionnaire (MDQ-30) at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'OG001', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.'}, {'id': 'OG002', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.16', 'spread': '1.16', 'groupId': 'OG000'}, {'value': '7.56', 'spread': '1.44', 'groupId': 'OG001'}, {'value': '5.36', 'spread': '2.17', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.'}, {'id': 'OG001', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'OG002', 'title': 'Standard Clinical Care Endoscopic Dilation, Then ESDT', 'description': 'Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.55', 'spread': '2.07', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '3.60', 'groupId': 'OG001'}, {'value': '5.17', 'spread': '2.04', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinically Significant Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'OG001', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.'}, {'id': 'OG002', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'OG003', 'title': 'Standard Clinical Care Endoscopic Dilation, Then ESDT', 'description': 'Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Number of clinically significant adverse events including perforation, bleeding and pain', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'FG001', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.'}, {'id': 'FG002', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'FG003', 'title': 'Standard Clinical Care Endoscopic Dilation, Then ESDT', 'description': 'Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}], 'periods': [{'title': 'Initial Study Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '12'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Treatment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Cross-over for Treatment Failure', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'recruitmentDetails': '6 subjects randomized to self-dilation group and 6 subjects randomized to standard of care with repeat endoscopy and dilations as needed at symptoms recurrence. 5 subjects from the standard of care group crossed over to receive self-dilation because they were considered treatment failures due to requiring 2 endoscopic dilation after 3 months of study participation. 14 subjects choose not to participate in the randomized trial, but did agree to be followed in a prospective observational group.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'BG001', 'title': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.'}, {'id': 'BG002', 'title': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'BG003', 'title': 'Standard Clinical Care Endoscopic Dilation, Then ESDT', 'description': 'Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.\n\nEsophageal self-dilation therapy: Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.\n\nEndoscopic therapy with esophageal dilation: A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Initial Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '64.0', 'spread': '11.0', 'groupId': 'BG000'}, {'value': '62.3', 'spread': '9.6', 'groupId': 'BG001'}, {'value': '62', 'spread': '15', 'groupId': 'BG002'}, {'value': '62.9', 'spread': '12.3', 'groupId': 'BG004'}]}]}, {'title': 'Cross-over for Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '65', 'spread': '7', 'groupId': 'BG003'}, {'value': '65', 'spread': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Data collected from the cross over study group are being reported separately to avoid multi-counted participants.', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data are reported separately for the initial phase and cross over phase. Data was not collected in the initial study phase for the Standard Clinical Care Endoscopic Dilation, Then ESDT group. Data was not collected in the cross-over for Treatment Failure phase for Standard Clinical Care Endoscopic Dilation Group, Esophageal Self-Dilation Therapy (ESDT) Group, or Observational Study Group as these groups were only part of the initial study phase.'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Initial Study Phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}, {'title': 'Cross-over for Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Data collected from the cross over study group are being reported separately to avoid multi-counted participants.'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '26', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Initial Study Phase', 'unitOfMeasure': 'participants', 'populationDescription': 'Data collected from the cross over study group are being reported separately to avoid multi-counted participants.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Cross-over for Treatment Failure', 'unitOfMeasure': 'participants', 'populationDescription': 'Data collected from the cross over study group are being reported separately to avoid multi-counted participants.'}], 'populationDescription': 'A total of 26 participants were enrolled in the overall study. 5 subjects in the Standard Clinical Care Endoscopic Dilation Group were considered treatment failures and were crossed over to the self-dilation group, resulting in a total of 31 participants analyzed for the Baseline Measures overall.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-19', 'size': 253771, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-07T12:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Subjects who agreed to participate in the randomized trial were randomized to standard clinical care consisting of endoscopic dilation as needed versus esophageal self-dilation therapy in a 1:1 ratio using a block randomization approach. Subjects randomized to the standard clinical care group were offered cross-over to the esophageal self-dilation therapy if they failed stand of care. Subjects who agreed to take part in in the observational prospective study either commenced ESDT or continued standard clinical care based on shared decision making with their esophageal provider.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-22', 'studyFirstSubmitDate': '2018-11-06', 'resultsFirstSubmitDate': '2023-04-21', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-22', 'studyFirstPostDateStruct': {'date': '2018-11-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Endoscopic Interventions', 'timeFrame': '6 months following serial dilation', 'description': 'Number of endoscopies required in a 6 month interval in subjects who achieved at least a 10-12 mm esophageal diameter during serial dilation for refractory benign esophageal stricture (RBES) and were subsequently treated with ESDT versus standard clinical care'}], 'secondaryOutcomes': [{'measure': 'Length of Days Intervention Free', 'timeFrame': '6 months', 'description': 'Number of days from start of study participation to 1st endoscopic intervention for recurrent dysphagia'}, {'measure': 'Mayo Dysphagia Questionnaire (MDQ-30) at Baseline', 'timeFrame': 'Baseline', 'description': 'The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"'}, {'measure': 'Mayo Dysphagia Questionnaire (MDQ-30) at 12 Months', 'timeFrame': '12 months', 'description': 'The MDQ-30 provides a series of questions for patients regarding their swallowing difficulties over the past 30 days. Participants were asked to rate the severity of their troubles swallowing on a scale of 0 to 10; 0 being "Not at all severe" and 10 being "Very severe"'}, {'measure': 'Clinically Significant Adverse Events', 'timeFrame': '12 months', 'description': 'Number of clinically significant adverse events including perforation, bleeding and pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Esophageal Dilation', 'Refractory Benign Esophageal Stricture']}, 'referencesModule': {'references': [{'pmid': '10381932', 'type': 'BACKGROUND', 'citation': 'Spechler SJ. American gastroenterological association medical position statement on treatment of patients with dysphagia caused by benign disorders of the distal esophagus. Gastroenterology. 1999 Jul;117(1):229-33. doi: 10.1016/s0016-5085(99)70572-x.'}, {'pmid': '25019695', 'type': 'BACKGROUND', 'citation': 'Mendelson AH, Small AJ, Agarwalla A, Scott FI, Kochman ML. Esophageal anastomotic strictures: outcomes of endoscopic dilation, risk of recurrence and refractory stenosis, and effect of foreign body removal. Clin Gastroenterol Hepatol. 2015 Feb;13(2):263-271.e1. doi: 10.1016/j.cgh.2014.07.010. Epub 2014 Jul 11.'}, {'pmid': '22008891', 'type': 'BACKGROUND', 'citation': 'de Wijkerslooth LR, Vleggaar FP, Siersema PD. Endoscopic management of difficult or recurrent esophageal strictures. Am J Gastroenterol. 2011 Dec;106(12):2080-91; quiz 2092. doi: 10.1038/ajg.2011.348. Epub 2011 Oct 18.'}, {'pmid': '16111985', 'type': 'BACKGROUND', 'citation': 'Kochman ML, McClave SA, Boyce HW. The refractory and the recurrent esophageal stricture: a definition. Gastrointest Endosc. 2005 Sep;62(3):474-5. doi: 10.1016/j.gie.2005.04.050. No abstract available.'}, {'pmid': '16377340', 'type': 'BACKGROUND', 'citation': 'Hordijk ML, Siersema PD, Tilanus HW, Kuipers EJ. Electrocautery therapy for refractory anastomotic strictures of the esophagus. Gastrointest Endosc. 2006 Jan;63(1):157-63. doi: 10.1016/j.gie.2005.06.016.'}, {'pmid': '16279894', 'type': 'BACKGROUND', 'citation': 'Ramage JI Jr, Rumalla A, Baron TH, Pochron NL, Zinsmeister AR, Murray JA, Norton ID, Diehl N, Romero Y. A prospective, randomized, double-blind, placebo-controlled trial of endoscopic steroid injection therapy for recalcitrant esophageal peptic strictures. Am J Gastroenterol. 2005 Nov;100(11):2419-25. doi: 10.1111/j.1572-0241.2005.00331.x.'}, {'pmid': '19491851', 'type': 'BACKGROUND', 'citation': 'Eloubeidi MA, Lopes TL. Novel removable internally fully covered self-expanding metal esophageal stent: feasibility, technique of removal, and tissue response in humans. Am J Gastroenterol. 2009 Jun;104(6):1374-81. doi: 10.1038/ajg.2009.133. Epub 2009 Apr 28.'}, {'pmid': '20236257', 'type': 'BACKGROUND', 'citation': 'Repici A, Hassan C, Sharma P, Conio M, Siersema P. Systematic review: the role of self-expanding plastic stents for benign oesophageal strictures. Aliment Pharmacol Ther. 2010 Jun;31(12):1268-75. doi: 10.1111/j.1365-2036.2010.04301.x. Epub 2010 Mar 17.'}, {'pmid': '21034894', 'type': 'BACKGROUND', 'citation': 'Repici A, Vleggaar FP, Hassan C, van Boeckel PG, Romeo F, Pagano N, Malesci A, Siersema PD. Efficacy and safety of biodegradable stents for refractory benign esophageal strictures: the BEST (Biodegradable Esophageal Stent) study. Gastrointest Endosc. 2010 Nov;72(5):927-34. doi: 10.1016/j.gie.2010.07.031.'}, {'pmid': '26542391', 'type': 'BACKGROUND', 'citation': 'Nijhawan S, Udawat HP, Nagar P. Aggressive bougie dilatation and intralesional steroids is effective in refractory benign esophageal strictures secondary to corrosive ingestion. Dis Esophagus. 2016 Nov;29(8):1027-1031. doi: 10.1111/dote.12438. Epub 2015 Nov 6.'}, {'pmid': '26828759', 'type': 'BACKGROUND', 'citation': 'Repici A, Small AJ, Mendelson A, Jovani M, Correale L, Hassan C, Ridola L, Anderloni A, Ferrara EC, Kochman ML. Natural history and management of refractory benign esophageal strictures. Gastrointest Endosc. 2016 Aug;84(2):222-8. doi: 10.1016/j.gie.2016.01.053. Epub 2016 Jan 30.'}, {'pmid': '23925823', 'type': 'BACKGROUND', 'citation': 'Dzeletovic I, Fleischer DE, Crowell MD, Pannala R, Harris LA, Ramirez FC, Burdick GE, Rentz LA, Spratley RV Jr, Helling SD, Alexander JA. Self-dilation as a treatment for resistant, benign esophageal strictures. Dig Dis Sci. 2013 Nov;58(11):3218-23. doi: 10.1007/s10620-013-2822-7. Epub 2013 Aug 8.'}, {'pmid': '23387392', 'type': 'BACKGROUND', 'citation': 'Zehetner J, DeMeester SR, Ayazi S, Demeester TR. Home self-dilatation for esophageal strictures. Dis Esophagus. 2014 Jan;27(1):1-4. doi: 10.1111/dote.12030. Epub 2013 Feb 6.'}, {'pmid': '24950654', 'type': 'BACKGROUND', 'citation': 'Kachaamy T, Lott D, Crujido LR, Rentz L, Fleischer D. Esophageal luminal restoration for a patient with a long lye-induced stricture via tunnel endoscopic therapy during a rendezvous procedure followed by self-dilation (with video). Gastrointest Endosc. 2014 Jul;80(1):192-4. doi: 10.1016/j.gie.2014.02.026. No abstract available.'}, {'pmid': '20927061', 'type': 'BACKGROUND', 'citation': 'Dzeletovic I, Fleischer DE. Self-dilation for resistant, benign esophageal strictures. Am J Gastroenterol. 2010 Oct;105(10):2142-3. doi: 10.1038/ajg.2010.212. No abstract available.'}, {'pmid': '21221805', 'type': 'BACKGROUND', 'citation': 'Dzeletovic I, Fleischer DE, Crowell MD, Kim HJ, Harris LA, Burdick GE, McLaughlin RR, Spratley RV Jr, Sharma VK. Self dilation as a treatment for resistant benign esophageal strictures: outcome, technique, and quality of life assessment. Dig Dis Sci. 2011 Feb;56(2):435-40. doi: 10.1007/s10620-010-1503-z. Epub 2011 Jan 8.'}, {'pmid': '20191010', 'type': 'BACKGROUND', 'citation': 'Lee HJ, Lee JH, Seo JM, Lee SK, Choe YH. A single center experience of self-bougienage on stricture recurrence after surgery for corrosive esophageal strictures in children. Yonsei Med J. 2010 Mar;51(2):202-5. doi: 10.3349/ymj.2010.51.2.202. Epub 2010 Feb 12.'}, {'pmid': '20927157', 'type': 'BACKGROUND', 'citation': 'Wong KK, Hendel D. Self-dilation for refractory oesophageal strictures: an Auckland City Hospital study. N Z Med J. 2010 Aug 27;123(1321):49-53.'}, {'pmid': '11676328', 'type': 'BACKGROUND', 'citation': 'Bapat RD, Bakhshi GD, Kantharia CV, Shirodkar SS, Iyer AP, Ranka S. Self-bougienage: long-term relief of corrosive esophageal strictures. Indian J Gastroenterol. 2001 Sep-Oct;20(5):180-2.'}, {'pmid': '38811502', 'type': 'DERIVED', 'citation': 'Halland M, Prichard DO, Kahn A, Lavey CJ, Katzka DA, Alexander JA. Esophageal Self-Dilation in Benign Refractory Esophageal Strictures: Outcomes from a Randomized Controlled Trial and a Prospective Observational Study. Dig Dis Sci. 2024 Aug;69(8):2883-2889. doi: 10.1007/s10620-024-08402-z. Epub 2024 May 29.'}], 'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study is being done to see which treatment is more effective in improving the difficulty of swallowing. Researchers are comparing self-dilation to endoscopic dilation.', 'detailedDescription': 'Benign esophageal strictures can be challenging condition to treat. The mainstay of treatment is endoscopic dilations. However, 30 to 40% of these strictures recur despite rigorous dilations. Although a consensus definition does not exist, a stricture is typically termed as a refractory benign esophageal stricture (RBES), when there is a failure to maintain luminal patency after at least 5 endoscopic dilations.\n\nPatients with RBES are extremely difficult to manage and the current armamentarium includes repeated endoscopic dilations, corticosteroid or mitomycin C injections, incisional therapy, and/ or temporary stent placement. These procedures are costly, their efficacy can be short-lived, and are associated with great burden both for the patient and clinician.\n\nEsophageal self -dilation therapy (ESDT) is where the patient learns to pass a polyvinyl dilator orally on a routine basis. In past, smaller studies, ESDT appears to be effective for RBES, reducing the number of endoscopic dilations from an average of 21.7 to an average of 1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Refractory benign esophageal stricture defined as an esophageal stricture with persistent dysphagia despite undergoing 5 endoscopic dilations within a 1 year period. Persistent dysphagia will be considered if patients has solid food dysphagia at least once a week\n\nExclusion Criteria:\n\n* Patient with malignant esophageal stricture\n* Angulated stricture which prevents safe passage of Maloney dilator in office setting\n* In ability to achieve an esophageal diameter of 10 mm with endoscopic dilation\n* Known significant esophageal motor disorder (i.e. achalasia, aperistalsis, functional obstruction, jackhammer, distal esophageal spasm)\\*\n* The presence of esophageal stent\n* Inability to learn self-dilation secondary to blindness or cognitive dysfunction\n* Use of chronic anticoagulants'}, 'identificationModule': {'nctId': 'NCT03738566', 'briefTitle': 'Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Outcomes of Esophageal Self Dilation for Benign Refractory Esophageal Stricture Management: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '18-000246'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Clinical Care Endoscopic Dilation Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects will undergo repeat upper endoscopy with dilation as needed if their dysphagia relapses which is the current standard of care. A relapse will be considered if a patient developed solid food dysphagia at least once a week.', 'interventionNames': ['Procedure: Endoscopic therapy with esophageal dilation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Esophageal Self-Dilation Therapy (ESDT) Group', 'description': 'Following standard clinical care consisting of serial endoscopic dilation to achieve an esophageal diameter of at least 10 mm, subjects are instructed to perform esophageal self-dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months.', 'interventionNames': ['Device: Esophageal self-dilation therapy']}, {'type': 'OTHER', 'label': 'Observational Study Group', 'description': 'Subjects undergo either esophageal self-dilation therapy or continued standard of clinical care base on shared decision making with their esophageal provider.', 'interventionNames': ['Device: Esophageal self-dilation therapy', 'Procedure: Endoscopic therapy with esophageal dilation']}, {'type': 'EXPERIMENTAL', 'label': 'Standard Clinical Care Endoscopic Dilation, Then ESDT', 'description': 'Subjects that received standard of clinical care endoscopic dilation who required two endoscopic dilations within 3 months of randomization were considered to have failed standard care and offered cross-over to the self-dilation therapy.', 'interventionNames': ['Device: Esophageal self-dilation therapy', 'Procedure: Endoscopic therapy with esophageal dilation']}], 'interventions': [{'name': 'Esophageal self-dilation therapy', 'type': 'DEVICE', 'otherNames': ['ESDT'], 'description': 'Patient learns to pass a polyvinyl dilator orally on a routine basis. Teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation therapy twice a day for at least one week.', 'armGroupLabels': ['Esophageal Self-Dilation Therapy (ESDT) Group', 'Observational Study Group', 'Standard Clinical Care Endoscopic Dilation, Then ESDT']}, {'name': 'Endoscopic therapy with esophageal dilation', 'type': 'PROCEDURE', 'description': 'A long, flexible tube is inserted down the throat into the esophagus and the narrow area of the esophagus is dilated, or stretched.', 'armGroupLabels': ['Observational Study Group', 'Standard Clinical Care Endoscopic Dilation Group', 'Standard Clinical Care Endoscopic Dilation, Then ESDT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Jeffrey Alexander, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jeffrey A Alexander', 'investigatorAffiliation': 'Mayo Clinic'}}}}