Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-03 @ 11:48 AM
Study NCT ID:
NCT02037659
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2014-01-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermabond Treatment for Gastric Variceal Bleeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004932', 'term': 'Esophageal and Gastric Varices'}], 'ancestors': [{'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006975', 'term': 'Hypertension, Portal'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100832', 'term': 'octyl 2-cyanoacrylate'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-27', 'studyFirstSubmitDate': '2014-01-14', 'studyFirstSubmitQcDate': '2014-01-14', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding.', 'timeFrame': '36 months', 'description': 'Patients with gastric variceal bleeding will be treated with DermaBond injection via EUS (endoscopic ultrasound). A follow-up EUS will observe the treated varices and determine if retreatment with DermaBond is necessary, or if observation alone is required.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Varices']}, 'descriptionModule': {'briefSummary': "The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.", 'detailedDescription': 'Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with DermaBond for gastric varices.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAnyone receiving treatment with DermaBond for treatment gastric varices.\n\nExclusion Criteria:\n\nNo evidence of gastric varices.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02037659', 'briefTitle': 'Dermabond Treatment for Gastric Variceal Bleeding', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Endoscopic Ultrasound (EUS) Gastric Variceal Bleeding Database Repository', 'orgStudyIdInfo': {'id': 'Dermabond'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gastric Varices treatment', 'description': 'DermaBond (glue) treatment of Gastric Varices.', 'interventionNames': ['Procedure: DermaBond treatment of Gastric Varices']}], 'interventions': [{'name': 'DermaBond treatment of Gastric Varices', 'type': 'PROCEDURE', 'otherNames': ['DermaBond: (cyanoacrylate tissue adhesive).'], 'description': 'Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.', 'armGroupLabels': ['Gastric Varices treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202-5121', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'John M. DeWitt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Endoscopic Ulatrsound', 'investigatorFullName': 'John DeWitt', 'investigatorAffiliation': 'Indiana University'}}}}