Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
Study NCT ID:
NCT04007692
Status:
TERMINATED
Last Update Posted:
2024-09-19
First Post:
2019-07-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004940', 'term': 'Esophageal Stenosis'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Accrual difficulties:\n\nThis trial was initiated prior to COVID-19 and interrupted by the pandemic for a significant length of time.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-11', 'studyFirstSubmitDate': '2019-07-02', 'studyFirstSubmitQcDate': '2019-07-02', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stent migration rate', 'timeFrame': '4 weeks post stent placement', 'description': 'Number of participants with stent migration as assessed by objective evidence of stent migration on endoscopy at 3-4 weeks after esophageal stent placement'}, {'measure': 'Adverse Events', 'timeFrame': '4 weeks', 'description': 'Number of adverse events reported'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esophageal stenosis', 'Endoscopic suturing', 'Esophageal stent fixation', 'Stent migration'], 'conditions': ['Esophageal Stenosis', 'Stent Migration', 'Suture, Complication']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'Researchers are trying to determine which suturing pattern for esophageal stent placement is more effective in a randomized fashion as currently what suturing pattern to use is an arbitrary decision.', 'detailedDescription': 'The participants who are receiving esophageal stent placement will be prospectively randomized to receive two suturing patterns (simple interrupted pattern and triangular pattern) for endoscopic esophageal stent fixation. We will investigate rate of the stent migration at 3-4 weeks by endoscopy after the stent placement as part of routine clinical care. Data of the duration of endoscopic suturing, adverse events, details of the stent used, indication for use will also be collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-vulnerable adults who are receiving an endoscopically placed esophageal stent for any indication at Mayo Clinic Rochester.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 18 or above\n* Subjects undergoing esophageal stent placement with any indication\n\nExclusion Criteria:\n\n* Imprisoned individuals,\n* Institutionalized patients\n* Inability or unwillingness of individual'}, 'identificationModule': {'nctId': 'NCT04007692', 'briefTitle': 'Optimal Endoscopic Suturing Pattern for Esophageal Stent Fixation', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Suturing Pattern for Endolumenal Stenting Procedures', 'orgStudyIdInfo': {'id': '18-003817'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Simple interrupted suture group', 'description': 'Participants will have a simple interrupted suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up.', 'interventionNames': ['Procedure: Esophageal stent placement']}, {'label': 'Triangular suture group', 'description': 'Participants will have a triangular suturing pattern, determined by care provider, at the time of esophageal stent placement for esophageal stent fixation as part of standard care and will have an endoscopy at 3-4 weeks after the stent placement as part of a routine follow-up.', 'interventionNames': ['Procedure: Esophageal stent placement']}], 'interventions': [{'name': 'Esophageal stent placement', 'type': 'PROCEDURE', 'description': 'Exposure of interest is standard of care esophageal stent placement', 'armGroupLabels': ['Simple interrupted suture group', 'Triangular suture group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Barham K Abu Dayyeh, 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': 'Barham K. Abu Dayyeh, M.D.', 'investigatorAffiliation': 'Mayo Clinic'}}}}