Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2025-12-26 @ 4:51 AM
Study NCT ID:
NCT05339594
Status:
TERMINATED
Last Update Posted:
2024-07-11
First Post:
2022-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REINVENT Registry (Registry of the Nerve Gap Repair From Integra)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059348', 'term': 'Peripheral Nerve Injuries'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Slow Enrollment, Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2022-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2022-04-06', 'studyFirstSubmitQcDate': '2022-04-15', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary clinical outcome measure is an evaluation of meaningful recovery as expressed by the Medical Research Council (MRC) scale as determined by the 2-point discrimination test (2PD).', 'timeFrame': '18 Months', 'description': 'The primary endpoint success is when each subject reaches meaningful recovery, which is defined as an MRC score of S3+ or S4 (fair, good or excellent 2PD) of the pulp assessment of the distal phalanx of the affected digit(s).'}], 'secondaryOutcomes': [{'measure': 'Evaluation of Static 2 Point Discrimination (s2PD) using DeMayo 2-point discrimination device', 'timeFrame': '18 Months', 'description': 'To be assessed via in office visits'}, {'measure': 'Evaluation of Moving 2PD using DeMayo 2-point discrimination device', 'timeFrame': '18 months', 'description': 'To be assessed via in office visits'}, {'measure': 'Evaluation of Michigan Hand and Outcomes Questionnaire (MHQ)', 'timeFrame': '15 Months', 'description': 'To be assessed via web based tool during at home visits'}, {'measure': 'Evaluation of Visual Analog Scale for Pain (VAS)', 'timeFrame': '15 Months', 'description': 'To be assessed via web based tool during at home visits'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Digital Nerve Gap Repair'], 'conditions': ['Peripheral Nerve Injuries']}, 'descriptionModule': {'briefSummary': "This is a prospective, multi-center, observational registry designed to evaluate two of Integra's collagen nerve gap repair products (NeuraGen® Nerve Guide and NeuraGen® 3D Nerve Guide Matrix). This registry will collect data on the outcome measures throughout the follow-up period for each patient. Data will be collected per standard of care.", 'detailedDescription': "Integra NeuraGen Nerve Guide has been approved for clinical use since 2001 and has become a recognized clinical option for clinical nerve repair for the type of injuries evaluated in this registry. Integra NeuraGen Nerve Guide is used in this registry as a comparator to a next-generation advanced nerve guide, Integra NeuraGen 3D Nerve Guide Matrix, that is based on the original Integra NeuraGen Nerve Guide technology but contains a regenerative matrix in the lumen.\n\nCenters chosen for participation will be current users of Integra's collagen nerve gap repair products listed above."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects with have had a repair of a peripheral nerve injury in the upper extremity distal to the palmer crease of the hand and without previous repairs.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject has undergone nerve gap repair utilizing NeuraGen or NeuraGen 3D\n* Subject is willing and able to comply with postoperative procedures and visits such as immobilization, etc.\n* Subject had a digital nerve injury that occurred up to 90 days prior to the nerve gap repair surgery detailed in this protocol.\n* Subject had digital nerve injury(ies) that involve(s) complete nerve section of a sensory nerve of the palmar aspect of the hand that is distal to the palmer crease of the hand.\n* Subject requires only a single repair per proper digital nerve branch\n\nExclusion Criteria:\n\n* Subject has a known history of hypersensitivity to bovine-derived or chondroitin-based materials.\n* Subject has participated in another clinical trial using an investigational drug or device within 30 days prior to the nerve repair surgery detailed in this protocol.\n* Subject's hand injury is of a nature which could negatively impact healing of the target nerves such as a crush or avulsion injury, incomplete transection of the target nerve, or complete separation of the digit affiliated with the target nerve\n* Subject has debris due to injury of the affected hand where contamination cannot be ruled out.\n* Subject has pre-existing nerve lesions or known diagnosis of compressive neuropathy of median or ulnar nerves (i.e., Cubital or carpal tunnel syndrome)\n* Subject has an infection of the area around the nerve defect.\n* Subjects with diagnosed Peripheral Vascular Disease and Peripheral Arterial Disease\n* Subject is known to have received immunosuppressive or antineoplastic agents or systemic steroids within 7 days of the study.\n* Subject is known to have had or will require radiation or other therapy to the target hand or limb which may impact nerve healing.\n* Subject has a history of injury to or a congenital abnormality of the target or contralateral hand or limb which may impact nerve healing or confound study results."}, 'identificationModule': {'nctId': 'NCT05339594', 'briefTitle': 'REINVENT Registry (Registry of the Nerve Gap Repair From Integra)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'Post-Market Clinical Follow-up Registry of Patients Requiring Nerve Gap Repair From Integra', 'orgStudyIdInfo': {'id': 'T-INVENT-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'NeuraGen Nerve Guide', 'description': 'Integra NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.', 'interventionNames': ['Device: NeuraGen']}, {'label': 'NeuraGen 3D Nerve Guide Matrix', 'description': 'Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.', 'interventionNames': ['Device: NeuraGen 3D']}], 'interventions': [{'name': 'NeuraGen', 'type': 'DEVICE', 'description': 'NeuraGen nerve guide is an absorbable implant for the repair of peripheral nerve gaps.', 'armGroupLabels': ['NeuraGen Nerve Guide']}, {'name': 'NeuraGen 3D', 'type': 'DEVICE', 'description': 'NeuraGen 3D Nerve guide matrix is a resorbable implant for the repair of peripheral nerve gaps.', 'armGroupLabels': ['NeuraGen 3D Nerve Guide Matrix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana Hand to Shoulder Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University at St Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center (UPMC)', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '22903', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '26501', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'Maria Leonard, BSN,RN,CTBS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Integra LifeSciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}