Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT00252369
Status:
TERMINATED
Last Update Posted:
2009-04-24
First Post:
2005-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'whyStopped': 'Low accrual rate', 'overallStatus': 'TERMINATED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'lastUpdateSubmitDate': '2009-04-23', 'studyFirstSubmitDate': '2005-11-10', 'studyFirstSubmitQcDate': '2005-11-10', 'lastUpdatePostDateStruct': {'date': '2009-04-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fistula healing'}], 'secondaryOutcomes': [{'measure': 'Quality of life'}, {'measure': 'Complications'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'descriptionModule': {'briefSummary': "This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.", 'detailedDescription': "Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Perianal fistula of Crohn's dis\n\nExclusion Criteria:\n\n* More then 2 fistulae perianal sepsis known contraindication to infliximab or glue"}, 'identificationModule': {'nctId': 'NCT00252369', 'briefTitle': "Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.", 'organization': {'class': 'OTHER_GOV', 'fullName': 'Sheba Medical Center'}, 'officialTitle': "Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.", 'orgStudyIdInfo': {'id': 'SHEBA-05-3762-OZ-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Infliximab', 'type': 'DRUG'}, {'name': 'Instillation of fibrin glue', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kfar Saba', 'country': 'Israel', 'facility': 'Meir Medical Center', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'city': 'Zrifin', 'country': 'Israel', 'facility': 'Assaf Harofe Medical Center'}], 'overallOfficials': [{'name': 'Oded Zmora, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sheba Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sheba Medical Center', 'class': 'OTHER_GOV'}}}}