Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-11 @ 9:56 AM
Study NCT ID:
NCT03626194
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2018-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2026-12-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2018-08-02', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical and clinical success in endoscopic tissue apposition', 'timeFrame': 'From baseline to one year', 'description': 'Successful completion of endoscopic suturing/clipping and measured as clinical symptom improvement as well as objective evidence of resolution / improvement of underlying pathology / confirmed with radiologic contrast studies as needed..'}, {'measure': 'Adverse Events', 'timeFrame': 'From baseline to one year', 'description': 'Based on ASGE criteria'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endoscopic Tissue Apposition', 'Endoscopic Suturing', 'Endoscopic Clipping', 'Bariatric Endoscopy', 'Transoral Outlet Reduction', 'Endoscopic Sleeve Gastroplasty']}, 'descriptionModule': {'briefSummary': 'This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.\n\n1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.\n\n1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A prospective database/registry of patients undergoing endoscopic tissue apposition will be formed. Women and minorities will be included as they are frequently found to have indications for which endoscopic tissue apposition may be indicated.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients\\>18 years of age undergoing endoscopy for any of the following indications:\n\nIndications for Tissue Apposition:\n\n* Closure of perforations\n* Closure of full thickness defects created during endoscopic full thickness resection\n* Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection\n* Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)\n* Stent fixation\n* Closure of fistulas\n* Natural Orifice Transluminal Endoscopic Surgery defect closures\n* Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)\n* Primary endoscopic sleeve gastroplasty\n\nExclusion Criteria:\n\n* Patients unable or unwilling to provide consent\n* Pregnant patients\n* Coagulation disorders (INR \\>1.8, platelet \\<50,000)\n* GI Bleeding\n* Hemodynamic instability\n* Enrollment in another device or drug study that may confound the results'}, 'identificationModule': {'nctId': 'NCT03626194', 'briefTitle': 'Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition', 'orgStudyIdInfo': {'id': '16-1826'}}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abigail Lowe', 'role': 'CONTACT', 'email': 'ABIGAIL.LOWE@UCDENVER.EDU', 'phone': '303-724-6070'}, {'name': 'Mihir Wagh, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Abigail Lowe', 'role': 'CONTACT', 'email': 'ABIGAIL.LOWE@UCDENVER.EDU', 'phone': '303-724-6070'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}