Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-03 @ 5:25 PM
Study NCT ID:
NCT00653094
Status:
UNKNOWN
Last Update Posted:
2008-04-04
First Post:
2008-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D005402', 'term': 'Fistula'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-03', 'studyFirstSubmitDate': '2008-04-01', 'studyFirstSubmitQcDate': '2008-04-03', 'lastUpdatePostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated', 'timeFrame': 'after sugery'}, {'measure': 'Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated', 'timeFrame': 'after surgery'}, {'measure': 'Success in inserting a draining Seton into the fistula tract by the Halevy kit', 'timeFrame': 'after surgery'}, {'measure': 'Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated', 'timeFrame': 'after surgery'}], 'secondaryOutcomes': [{'measure': 'Control of sphincter will be evaluated by -the Cleveland continence score', 'timeFrame': 'after follow up'}, {'measure': 'Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery.', 'timeFrame': 'after follow up'}, {'measure': 'Healing of the fistula will be evaluated by a physical examination', 'timeFrame': 'after follow up'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['crohn', 'fistula', 'surgery', 'fibrin glue', 'seton drainage'], 'conditions': ['Crohn Disease', 'Fistula']}, 'descriptionModule': {'briefSummary': 'Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. The injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. The use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. This study was design to test the use of Halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. In this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male and Female age greater than 18\n* Patients suffering from Crohn's disease\n* Patients with any number of simple or complex fistulas who require surgical intervention, requiring the insertion of a drain (Seton) into the fistula tract, and/or injection of biologic adhesive, or an anal fistula plug\n* Able and willing to sign an informed consent\n* Patient will be available for follow up.\n\nExclusion Criteria:\n\n* Pregnant or lactating woman. Woman of childbearing potential will undergo a pregnancy test at the beginning of the trial\n* Known immunodeficiency.\n* Exclusion Criteria for injecting biologic adhesive:\n\n * Known allergy to fibrin glue or one of its components.\n * An undrained perianal abscess, diagnosed by a physical examination or imaging methods.\n* Known Alcohol or drug abuse"}, 'identificationModule': {'nctId': 'NCT00653094', 'briefTitle': "An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'ResQ Medical Ltd'}, 'officialTitle': "An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease", 'orgStudyIdInfo': {'id': 'H.K.prot.02-03-08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'interventionNames': ['Device: Halevy kit']}], 'interventions': [{'name': 'Halevy kit', 'type': 'DEVICE', 'description': 'the use of Halevy kit in Crohn patients with Fistulas', 'armGroupLabels': ['A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Eran Mr Goldin, Prof', 'role': 'CONTACT'}, {'name': 'Eran dr Goldin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yossi Mr Lissi, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hadassah medical center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Eran Mr Goldin, Prof', 'role': 'CONTACT', 'phone': '02-6776848'}, {'name': 'Haim Mr Halevi, Dr.', 'role': 'CONTACT', 'phone': '052-2479211'}], 'overallOfficials': [{'name': 'Eran MR Goldin, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ResQ Medical Ltd', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Elisha Yalin', 'oldOrganization': 'ResQ Medical Ltd'}}}}