Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-01 @ 11:54 AM
Study NCT ID:
NCT01174992
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2010-08-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002558', 'term': 'Cerebrospinal Fluid Otorrhea'}], 'ancestors': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-19', 'studyFirstSubmitDate': '2010-08-03', 'studyFirstSubmitQcDate': '2010-08-03', 'lastUpdatePostDateStruct': {'date': '2012-06-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of success', 'timeFrame': 'Day 1 (intraoperative)', 'description': 'Proportion of success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage.'}], 'secondaryOutcomes': [{'measure': 'Incidence of CSF leakage', 'timeFrame': 'Day 5 post-op'}, {'measure': 'Incidence of CSF leakage', 'timeFrame': 'Day 30 post-op'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'up to 30 days post-op'}, {'measure': 'Incidence of surgical site infections', 'timeFrame': 'Day 5 and 30 post-op'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fibrin sealant', 'CSF leak'], 'conditions': ['Dura Defects']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety and efficacy of EVICEL for use as an adjunct to dura sutures in elective cranial surgery to provide intraoperative watertight closure.', 'detailedDescription': 'This is a randomized, multi-center controlled study evaluating the effectiveness of EVICEL\\* as an adjunct to sutured dural closure compared to control to obtain an intraoperative watertight dural closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing elective craniotomy/craniectomy\n* Age greater than or equal to 18 years\n* Patients who are able and willing to comply with the procedures required by the protocol.\n* Signed and dated written informed consent from the subject or from his/her legal representative prior to any study-related procedures.\n\nExclusion Criteria:\n\n* Chemotherapy or radiation therapy within 7 days following surgery.\n* Conditions compromising the immune system.\n* Known hypersensitivity to the components (human fibrinogen, arginine hydrochloride, glycine, sodium chloride, sodium citrate, calcium chloride, human thrombin, human albumin, mannitol and sodium acetate) of the investigational product.\n* Female subjects of childbearing potential with a positive pregnancy test prior to surgery.\n* Female subjects who are breastfeeding or intend to become pregnant during the clinical study period.\n* Participation in another clinical trial with exposure to another investigational drug or device within 30 days prior to enrollment.\n* Major intraoperative findings or complications identified by the surgeon that may preclude conduct of the planned surgical procedure.'}, 'identificationModule': {'nctId': 'NCT01174992', 'briefTitle': 'A Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ethicon, Inc.'}, 'officialTitle': 'A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL as an Adjunct to Sutured Dural Repair', 'orgStudyIdInfo': {'id': '400-09-001'}, 'secondaryIdInfos': [{'id': '2009-016501-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Evicel', 'interventionNames': ['Biological: Evicel']}, {'type': 'OTHER', 'label': 'Sutures only', 'interventionNames': ['Other: Sutures only']}], 'interventions': [{'name': 'Evicel', 'type': 'BIOLOGICAL', 'description': 'EVICEL is a human plasma derived fibrin sealant', 'armGroupLabels': ['Evicel']}, {'name': 'Sutures only', 'type': 'OTHER', 'description': 'Standard of care', 'armGroupLabels': ['Sutures only']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-3600', 'city': 'Genk', 'country': 'Belgium', 'facility': 'Department of Neurosurgery, Ziekenhuis Oost Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'zip': 'B-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Department of Neurosurgery, University Hospital of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}, {'zip': 'FI-33521', 'city': 'Tampere', 'country': 'Finland', 'facility': 'Department of Neurosciences and Rehabilitation, Tampere University Hospital', 'geoPoint': {'lat': 61.49911, 'lon': 23.78712}}, {'zip': '696 BRON', 'city': 'Cedex', 'country': 'France', 'facility': 'Service de Neurochirurgie B, Hopital Neurologique de Lyon'}, {'zip': 'D-45122', 'city': 'Essen', 'country': 'Germany', 'facility': 'Klinik für Neurochirurgie, Universitätsklinikum Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '35385', 'city': 'Giessen', 'country': 'Germany', 'facility': 'Department of Neurosurgery, University Giessen-Marburg', 'geoPoint': {'lat': 50.58727, 'lon': 8.67554}}, {'zip': '85049', 'city': 'Ingolstadt', 'country': 'Germany', 'facility': 'Department of Neurosurgery, Klinikum Ingolstadt GmbH', 'geoPoint': {'lat': 48.76508, 'lon': 11.42372}}, {'zip': 'D-24105', 'city': 'Kiel', 'country': 'Germany', 'facility': 'Department of Neurosurgery University Clinics of Schleswig-Holstein Campus Kiel', 'geoPoint': {'lat': 54.32133, 'lon': 10.13489}}, {'zip': '1081 HV', 'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'VU Medical Centre', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'zip': 'OX3 9DU', 'city': 'Headington', 'state': 'Oxford', 'country': 'United Kingdom', 'facility': 'Department of Neurosurgery, John Radcliffe Hospital', 'geoPoint': {'lat': 51.75737, 'lon': -1.21974}}, {'zip': 'DD1 9SY', 'city': 'Dundee', 'country': 'United Kingdom', 'facility': 'Department of Neurosurgery, Ninewells Hospital & Medical School', 'geoPoint': {'lat': 56.46913, 'lon': -2.97489}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Edinburgh Centre for Neuro-Oncology, Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'James Hart, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ethicon, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ethicon, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'OMRIX Biopharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}