Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-03-02 @ 8:05 AM
Study NCT ID:
NCT02800434
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2016-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2016-06-07', 'studyFirstSubmitQcDate': '2016-06-14', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fMRI for evaluation of brain plasticity after transplant', 'timeFrame': '1 year', 'description': 'Evaluation of brain plasticity after transplant'}], 'secondaryOutcomes': [{'measure': 'Rejection', 'timeFrame': 'Every 6 months following graft up to 5 years'}, {'measure': 'Adverse events', 'timeFrame': '5 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['allograft', 'hands', 'immunosuppression', 'fMRI'], 'conditions': ['Amputation']}, 'referencesModule': {'references': [{'pmid': '24646555', 'type': 'BACKGROUND', 'citation': 'Petruzzo P, Gazarian A, Kanitakis J, Parmentier H, Guigal V, Guillot M, Vial C, Dubernard JM, Morelon E, Badet L. Outcomes after bilateral hand allotransplantation: a risk/benefit ratio analysis. Ann Surg. 2015 Jan;261(1):213-20. doi: 10.1097/SLA.0000000000000627.'}]}, 'descriptionModule': {'briefSummary': 'The double amputation of the forearms is a rare handicap that seriously impacts the autonomy and the quality of life of patients, social and familial exclusion, and dependence on third parties for everyday activities.\n\nThe management of these patients is nearly exclusively through the use of prostheses. Certain patients refuse this solution, or remain penalized by the absence of sensation, the lack of precision in movements, and body image issues related to the amputation; the double graft of hands and forearms may, in this circumstance, be the only solution.\n\nThe objective of this pilot study was designed to evaluate the cerebral plasticity of patients who undergo bilateral hand allograph'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* double amputated patients\n* minimum of 3 months and maximum of 3 years interval between amputation and graft\n* adult aged 20 to 40 years\n* psychological maturity\n* written informed consent\n\nExclusion Criteria:\n\n* mono amputated patients\n* previous history of malignant tumor in remission for less than 5 years,\n* malignant tumor\n* previous psychiatric history\n* American Society of Anesthesiology (ASA) score \\>2\n* New York Heart Association (NYHA) \\>1\n* nenal insufficiency\n* severe hypertension'}, 'identificationModule': {'nctId': 'NCT02800434', 'briefTitle': 'Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Clinical Evaluation of Bilateral Hand Allograft: Pilot Study of 7 Cases', 'orgStudyIdInfo': {'id': '99-176'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'hand allograft', 'interventionNames': ['Procedure: hand allograft']}], 'interventions': [{'name': 'hand allograft', 'type': 'PROCEDURE', 'armGroupLabels': ['hand allograft']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': "Service d'Urologie et Chirurgie de la Transplantion", 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'overallOfficials': [{'name': 'Lionel BADET', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Hospices Civils de Lyon - Service d'Urologie et Chirurgie de la Transplantion"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}