Ignite Creation Date:
2025-12-24 @ 4:28 PM
Ignite Modification Date:
2026-01-01 @ 8:24 AM
Study NCT ID:
NCT01290666
Status:
TERMINATED
Last Update Posted:
2017-01-13
First Post:
2011-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '888-532-4123', 'title': 'Michael J Stamos, MD', 'organization': 'University of California, Irvine'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'GORE® BIO-A® Fistula Plug', 'description': 'All patients in study receive the GORE® BIO-A® Fistula Plug.\n\nFistula Plug: Bioabsorbable fistula plug', 'otherNumAtRisk': 93, 'otherNumAffected': 45, 'seriousNumAtRisk': 93, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 15, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Extrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 16, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Unresolved Fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 12, 'numAffected': 7}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Other', 'stats': [{'groupId': 'EG000', 'numAtRisk': 93, 'numEvents': 56, 'numAffected': 25}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Fistula Closure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'GORE® BIO-A® Fistula Plug', 'description': 'All patients in study receive the GORE® BIO-A® Fistula Plug.\n\nFistula Plug: Bioabsorbable fistula plug'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months post procedure', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Drainage Post Procedure', 'timeFrame': 'Follow up out to 12 months post procedure', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GORE® BIO-A® Fistula Plug', 'description': 'All patients in study receive the GORE® BIO-A® Fistula Plug.\n\nFistula Plug: Bioabsorbable fistula plug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '93'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '23'}]}, {'type': 'Early Termination of Study', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}], 'recruitmentDetails': 'A total of 93 subjects were recruited from 11 sites between March of 2011 and September 2013.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '93', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GORE® BIO-A® Fistula Plug', 'description': 'All patients in study receive the GORE® BIO-A® Fistula Plug.\n\nFistula Plug: Bioabsorbable fistula plug'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '80', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '71', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '93', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sufficient patient population achieved; decision not due to product complaints.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2011-02-03', 'resultsFirstSubmitDate': '2015-11-09', 'studyFirstSubmitQcDate': '2011-02-04', 'lastUpdatePostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-15', 'studyFirstPostDateStruct': {'date': '2011-02-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula Closure', 'timeFrame': '12 months post procedure'}], 'secondaryOutcomes': [{'measure': 'Duration of Drainage Post Procedure', 'timeFrame': 'Follow up out to 12 months post procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Anal Fistula']}, 'referencesModule': {'references': [{'pmid': '25664714', 'type': 'DERIVED', 'citation': 'Stamos MJ, Snyder M, Robb BW, Ky A, Singer M, Stewart DB, Sonoda T, Abcarian H. Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. Dis Colon Rectum. 2015 Mar;58(3):344-51. doi: 10.1097/DCR.0000000000000288.'}]}, 'descriptionModule': {'briefSummary': 'Primary outcome variable is healing at the final follow up visit.', 'detailedDescription': 'The primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the GORE® BIO-A® Fistula Plug when used as a soft tissue reinforcement of anal fistula repair and healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients presenting with anal fistulae that meet inclusion and exclusion criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure\n* Likely cryptoglandular origin\n* Must be at least 18 years of age\n* Patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use PHI data, as applicable\n* Patients willing and able to submit to postoperative follow-up evaluations\n\nExclusion Criteria:\n\n* Crohn's Disease\n* Evidence of on-going local infection\n* History of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, LIFT\n* Superficial fistulas without any muscle involvement\n* Fistulae of traumatic origin, including obstetric\n* Intersphincteric fistulas that would be candidate for fistulotomy\n* Horseshoe or multi-tract fistulas\n* Ano-vaginal or recto-vaginal fistulas\n* Anastomotic fistulas (ileo-anal, colo-anal)\n* A wound-healing or autoimmune disorder (including insulin-dependent diabetics)\n* Subjects who are immunocompromised such as, with HIV, or currently receiving chemo or radiation therapy\n* Subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, TNF agents, methotrexate\n* History of prior or current pelvic radiation\n* Difficulty comprehending or complying with the study (in surgeon's opinion)"}, 'identificationModule': {'nctId': 'NCT01290666', 'briefTitle': 'Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'W.L.Gore & Associates'}, 'officialTitle': 'Multicenter,Prospective, Observational Study of GORE® BIO-A® Fistula Plug for Use in Anal Fistula Repair', 'orgStudyIdInfo': {'id': 'CS157'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'GORE® BIO-A® Fistula Plug', 'description': 'All patients in study receive the GORE® BIO-A® Fistula Plug.', 'interventionNames': ['Device: Fistula Plug']}], 'interventions': [{'name': 'Fistula Plug', 'type': 'DEVICE', 'otherNames': ['GORE® BIO-A® Fistula Plug'], 'description': 'Bioabsorbable fistula plug', 'armGroupLabels': ['GORE® BIO-A® Fistula Plug']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Michael J Stamos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'W.L.Gore & Associates', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}