Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-24 @ 6:37 PM
Study NCT ID:
NCT03966157
Status:
COMPLETED
Last Update Posted:
2023-05-19
First Post:
2019-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-04-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 's.burton.1818@gmail.com', 'phone': '3147500811', 'title': 'Dr. Samuel J. Burton', 'organization': 'Saint Louis University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year', 'eventGroups': [{'id': 'EG000', 'title': 'Nasal Bridle', 'description': 'Patients randomized to nasal bridle.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 0, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Standard', 'description': 'Patients randomized with adhesive tape.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 0, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Repeat Endoscopy to Replace Dislodged Feeding Tube', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Bridle', 'description': 'Patients randomized to have nasal bridle.\n\nNasal Bridle: Feeding tube secured with nasal bridle'}, {'id': 'OG001', 'title': 'Standard', 'description': 'Patients randomized with adhesive tape.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'The number of participants that require a repeat endoscopy to place an additional nasoenteric tube due to inadvertent dislodgement', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One patient randomized to nasal bridle completed procedure but was lost to follow-up'}, {'type': 'SECONDARY', 'title': 'Inadvertent Tube Dislodgement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Nasal Bridle', 'description': 'Patients randomized to have nasal bridle.\n\nNasal Bridle: Feeding tube secured with nasal bridle'}, {'id': 'OG001', 'title': 'Standard', 'description': 'Patients randomized with adhesive tape.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12 months', 'description': 'Number of participants that inadvertently have nasoenteric tube dislodged', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nasal Bridle', 'description': 'Patients randomized to have nasal bridle.\n\nNasal Bridle: Feeding tube secured with nasal bridle'}, {'id': 'FG001', 'title': 'Standard', 'description': 'Patients randomized with adhesive tape.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Nasal Bridle', 'description': 'Patients randomized to have nasal bridle.\n\nNasal Bridle: Feeding tube secured with nasal bridle'}, {'id': 'BG001', 'title': 'Standard', 'description': 'Patients randomized with adhesive tape.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.8', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '77'}, {'value': '53.4', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '82'}, {'value': '54.0', 'groupId': 'BG002', 'lowerLimit': '18', 'upperLimit': '82'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], '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': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'One patient randomized to nasal bridle, but did not complete study as there was change in clinical status'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-13', 'size': 433794, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-18T11:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2019-05-22', 'resultsFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2019-05-27', 'lastUpdatePostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-17', 'studyFirstPostDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Repeat Endoscopy to Replace Dislodged Feeding Tube', 'timeFrame': '12 months', 'description': 'The number of participants that require a repeat endoscopy to place an additional nasoenteric tube due to inadvertent dislodgement'}], 'secondaryOutcomes': [{'measure': 'Inadvertent Tube Dislodgement', 'timeFrame': '12 months', 'description': 'Number of participants that inadvertently have nasoenteric tube dislodged'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Feeding Disorders']}, 'descriptionModule': {'briefSummary': 'In critically ill patients, nutrition is a major part of healing and recovery. In patients unable to tolerate oral feeding, nasoenteric tube feeding (a tube placed from the nose to the stomach or small intestine) provides a safe alternative for feeding. Some patients require these tubes to be placed endoscopically due to numerous patient factors including difficult anatomy, need for post-gastric feeding, among others). In patients that require endoscopically placed tubes, there is risk of perforation, infection, bleeding, aspiration, and rarely even death. In patients that have recurrent dislodgement of endoscopically placed tubes, the need for repeat endoscopy increases patient exposure to these risks. Traditional securing mechanism with adhesive tape to reduce dislodgment often fail in critically ill patients requiring patients to have repeat endoscopies to replace nasoenteric feeding tubes and subjects patients potentially to increased cumulative risks associated with each endoscopy.\n\nThe investigators propose to collect data for one year, the investigators will prospectively follow via chart review endoscopically placed naso-enteric tubes placed with a Standard AMT Bridle securement device and assess if there is a reduction in accidental tube removal requiring replacement endoscopically.', 'detailedDescription': 'Patients to be recruited are those who are scheduled to undergo routine upper endoscopy with nasoenteric tube placement. Patients will be randomized into two groups: control arm and device arm.\n\nControl arm includes patients that will have nasoenteric tubes secured with standard protocol, adhesive tape. Device arm includes patients that will have nasoenteric tubes secured with Standard AMT Bridle. The nasal bridles will be placed by the endoscopist. Upper endoscopy will not be affected. Placement of nasal bridle will take 1-2 minutes after endoscopic procedure completed. No addition sedation, medication or exposure necessary.\n\nPatients will be randomized by sealed envelope randomization. Clinicians are given randomly generated treatment allocations within sealed opaque envelopes. Once a patient has consented to enter the study trial an envelope is opened and the patient is then offered the allocated treatment regimen. Patients will be consented by a member of the research team prior to endoscopy. Randomization will be singly blinded only to the the patient prior to endoscopy. Endoscopist will not be blinded as they will be placing the securement device and in order to reduce selection bias.\n\nIn the event of tube dislodgment, the patient will receive same treatment.\n\nFollow-up of patients will occur via chart review until the time of discharge, at 6 months and at 12 months after feeding tube placement via chart review. Data collected with include repeat EGD, length of endoscopy, length of hospital stay, and mortality. The number of endoscopies and repeated nasoenteric tubes placed will be tracked at six and twelve months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in need for endoscopically placed nasoenteric feeding tube\n\nExclusion Criteria:\n\n* Age greater than 90 years'}, 'identificationModule': {'nctId': 'NCT03966157', 'briefTitle': 'Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes', 'organization': {'class': 'OTHER', 'fullName': 'St. Louis University'}, 'officialTitle': 'The Role of a Nasal Bridle in the Frequency of Repeat Endoscopic Procedures for Endoscopic Naso-enteric Tube Placement', 'orgStudyIdInfo': {'id': '29703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasal Bridle', 'description': 'Patients randomized to have nasal bridle.', 'interventionNames': ['Device: Nasal Bridle']}, {'type': 'NO_INTERVENTION', 'label': 'Standard', 'description': 'Patients randomized with adhesive tape.'}], 'interventions': [{'name': 'Nasal Bridle', 'type': 'DEVICE', 'description': 'Feeding tube secured with nasal bridle', 'armGroupLabels': ['Nasal Bridle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63109', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Samuel Burton', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Louis University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterology Fellow', 'investigatorFullName': 'Samuel Burton, MD', 'investigatorAffiliation': 'St. Louis University'}}}}