Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-02 @ 10:14 AM
Study NCT ID:
NCT03321266
Status:
COMPLETED
Last Update Posted:
2019-09-25
First Post:
2017-10-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2017-10-20', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of fistula closure', 'timeFrame': 'up to 2 years', 'description': 'Absence of drainage from the external fistula opening with complete epithelialization of the external fistula opening upon clinical exam.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Fistula plug'], 'conditions': ['Anorectal Fistula']}, 'descriptionModule': {'briefSummary': 'The study is a retrospective review of the use of the Biodesign® Fistula Plug (C-FPS-\\[X\\]). A total of 73 patients will be enrolled who have had a fistula plug placed to treat anorectal fistulas and will therefore be eligible for statistical analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients implanted with the Cook Biodesign Fistula Plug at each of the participating institutions through 31 Dec 2016 will be included in the retrospective data collection regardless of outcome. A patient must have at least one follow-up visit.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have had surgery to treat anorectal fistula where the Biodesign® Fistula Plug was placed during the procedure\n\nExclusion Criteria:\n\n* Patients not receiving the Biodesign® Fistula Plug for treatment of their anorectal fistula'}, 'identificationModule': {'nctId': 'NCT03321266', 'briefTitle': 'Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'A Retrospective Review of the Use of the Cook Biodesign® Fistula Plug (C-FPS-0.2, C-FPS-0.4, and C-FPS-0.7) to Treat Anorectal Fistulas', 'orgStudyIdInfo': {'id': '17-03'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated for a anorectal fistula', 'description': 'Patients who were treated for a anorectal fistula with a Biodesign Fistula plug', 'interventionNames': ['Device: Cook Biodesign® Fistula Plug']}], 'interventions': [{'name': 'Cook Biodesign® Fistula Plug', 'type': 'DEVICE', 'description': 'The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.', 'armGroupLabels': ['Patients treated for a anorectal fistula']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville School of Medicine', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Our Lady of the Lake Regional Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '02904', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'University Surgical Associates', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '65189', 'city': 'Wiesbaden', 'country': 'Germany', 'facility': "St Josef's Hospital", 'geoPoint': {'lat': 50.08601, 'lon': 8.24435}}], 'overallOfficials': [{'name': 'Adal Saeed, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St Josef's Hospital, Wiesbaden"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Group Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}