Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 12:24 AM
Study NCT ID:
NCT04057157
Status:
COMPLETED
Last Update Posted:
2022-10-14
First Post:
2019-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Assessment of Biodesign Dural Repair Grafts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065634', 'term': 'Cerebrospinal Fluid Leak'}, {'id': 'D002558', 'term': 'Cerebrospinal Fluid Otorrhea'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-13', 'studyFirstSubmitDate': '2019-08-13', 'studyFirstSubmitQcDate': '2019-08-13', 'lastUpdatePostDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients without clinically relevant cerebrospinal fluid (CSF) leakage', 'timeFrame': '2 months', 'description': 'Clinically relevant CSF leakage is when it requires treatment (e.g., lumbar drain or surgical repair) or leads to an infection of the central nervous system (e.g., meningitis).'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dura mater repair', 'cerebrospinal fluid leak', 'CSF leak', 'Biodesign® Dural Repair Graft', 'Biodesign® Duraplasty Repair Graft'], 'conditions': ['Cerebrospinal Fluid Leak']}, 'descriptionModule': {'briefSummary': 'The purpose of this clinical study is to gather post-market clinical evidence on the use of the Biodesign® Dural and Duraplasty Grafts when used as a dura substitute of the dura mater.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have had dura mater repair using a Biodesign Dural or Duraplasty Graft.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Planned use of the Biodesign Dural or Duraplasty Graft.\n\nExclusion Criteria:\n\n1. Age \\<18 years\n2. Unable or unwilling to provide informed consent\n3. Life expectancy \\<6 months'}, 'identificationModule': {'nctId': 'NCT04057157', 'briefTitle': 'Post-market Assessment of Biodesign Dural Repair Grafts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cook Group Incorporated'}, 'officialTitle': 'Post-market Clinical Data Collection Plan for the Biodesign® Dural and Duraplasty Grafts', 'orgStudyIdInfo': {'id': '17-10'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Biodesign Dural or Duraplasty Repair Grafts', 'type': 'DEVICE', 'description': 'Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama Birmingham Hospital', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '40139', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Ospedale Bellaria-Bolonga', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Cook Research Incorporated (CRI) is fully committed to supporting the principles of responsible data sharing, including providing qualified scientific researchers access to deidentified, patient-level data from CRI clinical studies to conduct legitimate scientific research. Data underlying the results reported in this clinical study will be made available for request after final report has been distributed and ending 5 years after final report has been distributed. Interested researchers may review the "Cook Research Incorporated Policy on Access to Clinical Study Data" at https://www.cookresearchinc.com/extranet/data-access.html and submit a complete research proposal to request data access. Additional study documents (such as the study protocol) will be shared as needed if the data access request is granted. A data sharing agreement will be executed for access to deidentified patient-level data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cook Research Incorporated', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}