Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-29 @ 7:06 AM
Study NCT ID:
NCT01958632
Status:
COMPLETED
Last Update Posted:
2013-10-09
First Post:
2013-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Muscle-in-vein Conduits for Digital Nerve Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-05', 'studyFirstSubmitDate': '2013-10-05', 'studyFirstSubmitQcDate': '2013-10-05', 'lastUpdatePostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semmes-Weinstein-Monofilament test', 'timeFrame': 'The earliest 6 months post-OP'}], 'secondaryOutcomes': [{'measure': 'Two-point-discrimination', 'timeFrame': 'The earliest 6 months post-OP'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sensory Recovery']}, 'descriptionModule': {'briefSummary': 'The actual study should provide a first direct comparison between results after reconstruction of sensory nerves of the hand using muscle-in-vein conduits to the standard methods of nerve transplantation and direct nerve suture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ncomplete digital nerve injuries, nerve reconstruction in the first 6 months post trauma\n\nExclusion Criteria:\n\ntotal or subtotal amputations'}, 'identificationModule': {'nctId': 'NCT01958632', 'briefTitle': 'Muscle-in-vein Conduits for Digital Nerve Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'BG Trauma Center Tuebingen'}, 'officialTitle': 'Evaluation of Sensory Recovery After Reconstruction of Digital Nerves of the Hand Using Muscle-in-vein Conduits in Comparison to Nerve Suture or Nerve Transplantation', 'orgStudyIdInfo': {'id': '117/2012BO2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'N', 'description': 'nerve suture', 'interventionNames': ['Procedure: Nerve reconstruction']}, {'label': 'NT', 'description': 'nerve transplantation', 'interventionNames': ['Procedure: Nerve reconstruction']}, {'label': 'VM', 'description': 'vein-in-muscle conduit', 'interventionNames': ['Procedure: Nerve reconstruction']}], 'interventions': [{'name': 'Nerve reconstruction', 'type': 'PROCEDURE', 'armGroupLabels': ['N', 'NT', 'VM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'BG Trauma Center', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'BG Trauma Center Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Plastic Surgeon', 'investigatorFullName': 'Dr. Theodora Manoli', 'investigatorAffiliation': 'BG Trauma Center Tuebingen'}}}}