Ignite Creation Date:
2025-12-24 @ 3:14 PM
Ignite Modification Date:
2025-12-25 @ 3:28 PM
Study NCT ID:
NCT00792792
Status:
WITHDRAWN
Last Update Posted:
2022-11-01
First Post:
2008-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Tissue Transfer Flaps by Modulated Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Not a clinical trial study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2008-11-14', 'studyFirstSubmitQcDate': '2008-11-14', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transfer Skin flap', 'timeFrame': 'up to 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['tissue transfer'], 'conditions': ['Other Reconstructive Surgery']}, 'descriptionModule': {'briefSummary': 'Tissue transfer flaps are a method of moving tissue from a donor location to a recipient location. In the case of a free tissue transfer flaps, the blood vessels to the transferred tissues are detached and then re-attached to different arteries and veins at the recipient site. The process of reconstructive surgery using tissue transfer flaps is not without complications. These complications may include acute arterial or venous occlusion, as well as the development of late complications such as fat necrosis and flap atrophy.', 'detailedDescription': "The researchers developed a safe, non-contact, intra-operative and post-operative device called Modulated Imaging, can detect changes in a flap's optical properties and can correlate with arterial or venous occlusion or with the development of fat necrosis or flap atrophy."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Study population will be selected from Surgical Department as outpatients and in-patient bases that require reconstructive surgery using a pedicle or free tissue transfer flap.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult 18 years and older planned to undergo reconstructive surgery\n\nExclusion Criteria:\n\n* All emergency reconstructive surgery'}, 'identificationModule': {'nctId': 'NCT00792792', 'briefTitle': 'Monitoring of Tissue Transfer Flaps by Modulated Imaging', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Non-contact, Intra-operative & Post-operative Device, Evaluation of Tissue Transfer Flaps After Reconstructive Surgery.', 'orgStudyIdInfo': {'id': '20075891'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tissue transfer skin flap', 'description': 'Modulated Imaging Spectroscopy', 'interventionNames': ['Device: Modulated Imaging']}], 'interventions': [{'name': 'Modulated Imaging', 'type': 'DEVICE', 'description': 'Modulated Imaging Spectroscopy', 'armGroupLabels': ['Tissue transfer skin flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California Medical Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Evans R Gregory, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Aesthetic & Plastic Surgery Institute, UCIMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beckman Laser Institute University of California Irvine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gregory Evans, M.D., Chair, Department of Plastic Surgery', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}