Ignite Creation Date:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2026-02-26 @ 7:49 PM
Study NCT ID:
NCT03875833
Status:
WITHDRAWN
Last Update Posted:
2023-05-22
First Post:
2019-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010292', 'term': 'Paresthesia'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020886', 'term': 'Somatosensory Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Lack of enrollment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-10-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-18', 'studyFirstSubmitDate': '2019-03-13', 'studyFirstSubmitQcDate': '2019-03-13', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function', 'timeFrame': 'baseline'}, {'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function', 'timeFrame': '3 months'}, {'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function', 'timeFrame': '6 months'}, {'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by subjective patient questionnaire regarding upper extremity sensation and function', 'timeFrame': '12 months'}, {'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings', 'timeFrame': 'baseline', 'description': 'Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.'}, {'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings', 'timeFrame': '3 months', 'description': 'Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.'}, {'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings', 'timeFrame': '6 months', 'description': 'Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.'}, {'measure': 'Number of participants with normal sensory recovery at the site of forearm free flap as assessed by objective clinical findings', 'timeFrame': '12 months', 'description': 'Participants will be evaluated clinically using pinprick, light touch, and two-point discrimination tests. An overall score will be reported.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Head and Neck Neoplasms', 'Dysesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether collagen nerve conduits placed on exposed radial and ulnar nerves during radial and ulnar forearm free flap harvests will reduce the occurrence and degree of sensory nerve deficit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients present with a complex defect after tumor resection\n* all these cases done with the departments of Oral and Maxillofacial Surgery and Otolaryngology at the University of Texas in multiple locations that include, Memorial Hermann Hospital, Ben Taub General Hospital, Lyndon B. Johnson General Hospital and The Methodist hospital.\n* patients that have been diagnosed with head and neck tumors and who will undergo a composite resection and reconstruction with radial or ulnar free vascularized flap.\n\nExclusion Criteria:\n\n* pre-existing nerve deficits\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT03875833', 'briefTitle': 'Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Prospective Analysis of Effect of Collagen Wrap Conduit on Radial and Ulnar Nerve Function Following Radial/Ulnar Forearm Free Flap Harvest', 'orgStudyIdInfo': {'id': 'HSC-DB-18-0760'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Collagen Nerve Wrap Conduit', 'interventionNames': ['Device: Collagen Nerve Wrap Conduit']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Collagen Nerve Wrap Conduit', 'type': 'DEVICE', 'description': 'The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.', 'armGroupLabels': ['Collagen Nerve Wrap Conduit']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'James C Melville, DDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'James C Melville', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}