Ignite Creation Date:
2025-12-24 @ 10:44 PM
Ignite Modification Date:
2025-12-31 @ 11:31 PM
Study NCT ID:
NCT05718635
Status:
UNKNOWN
Last Update Posted:
2023-03-28
First Post:
2022-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perforator Mapping and Optimizing Design of the Lateral Arm Flap
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': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-26', 'studyFirstSubmitDate': '2022-10-12', 'studyFirstSubmitQcDate': '2023-01-30', 'lastUpdatePostDateStruct': {'date': '2023-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numbers of perforators', 'timeFrame': 'two years', 'description': 'numbers of perforators in the flap'}, {'measure': 'site of perforators', 'timeFrame': 'two years', 'description': 'distance from lateral humeral epicondyle in CM'}, {'measure': 'Size of perforators', 'timeFrame': 'two years', 'description': 'size in millimeter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coverage of Soft Tissue Defects']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to optimize the design of lateral arm flap. Colored duplex will be done for all Participants and compared to intra operative findings.\n\nflap modification (Supra facial) dissection to lateral arm flap will be done and the results will compared to the ordinary method of dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients\n\nExclusion Criteria:\n\n* children injury to pedicle'}, 'identificationModule': {'nctId': 'NCT05718635', 'briefTitle': 'Perforator Mapping and Optimizing Design of the Lateral Arm Flap', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University'}, 'officialTitle': 'Perforator Mapping and Optimizing Design of the Lateral Arm Flap: Clinical Trial', 'orgStudyIdInfo': {'id': 'AswanU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients candidate for lateral arm flap', 'interventionNames': ['Diagnostic Test: coloured duplex', 'Procedure: supra facial dissection']}], 'interventions': [{'name': 'coloured duplex', 'type': 'DIAGNOSTIC_TEST', 'description': 'colored duplex to locate numbers sites and size of perforators.', 'armGroupLabels': ['patients candidate for lateral arm flap']}, {'name': 'supra facial dissection', 'type': 'PROCEDURE', 'description': 'flap raising in supra facial plane', 'armGroupLabels': ['patients candidate for lateral arm flap']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'OSAMA ELBANNA, MD', 'role': 'CONTACT', 'email': 'osamaelbanna@aswu.edu.eg', 'phone': '021067076234'}], 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}], 'centralContacts': [{'name': 'OSAMA ELBANNA, MD.', 'role': 'CONTACT', 'email': 'osamaelbanna@aswu.edu.eg', 'phone': '021067076234'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Osama Hassan Elbanna', 'investigatorAffiliation': 'Aswan University'}}}}