Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2026-04-19 @ 9:52 PM
Study NCT ID:
NCT01313000
Status:
COMPLETED
Last Update Posted:
2012-03-26
First Post:
2011-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study To Evaluate Upper Arm Autologous Fat Transfer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C564245', 'term': 'Platelet Glycoprotein IV Deficiency'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2011-03-09', 'studyFirstSubmitQcDate': '2011-03-10', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fat, transfer, autologous fat transfer, bicep'], 'conditions': ['Cosmetic and Circumferential Change After Fat Transfer']}, 'descriptionModule': {'briefSummary': 'The objective of this pilot study is to observe the utility of autologous transfer of fat collected using ultrasonic assisted liposuction into the upper arms with ultrasonic visualization.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients undergoing abdominal liposuction who wish autologous fat transfer to the upper arms', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Is male.\n2. Is between 20 and 50 years of age, inclusive, on the day of enrolment.\n3. Is to undergo abdominal liposuction.\n4. Wishes to undergo autologous fat transfer to the upper arms.\n\nExclusion Criteria:\n\n1. Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.\n2. Undergoing body contouring for reconstruction following injury or disease.\n3. Deemed inappropriate candidates for the surgical procedures for any reason.\n4. Are unwilling to undergo the study procedures or participate fully in all follow-up.'}, 'identificationModule': {'nctId': 'NCT01313000', 'briefTitle': 'Study To Evaluate Upper Arm Autologous Fat Transfer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sound Surgical Technologies, LLC.'}, 'officialTitle': 'Pilot Study To Evaluate Upper Arm Autologous Fat Transfer', 'orgStudyIdInfo': {'id': 'SST2001-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autologous fat transfer', 'interventionNames': ['Procedure: Autologous fat transfer']}], 'interventions': [{'name': 'Autologous fat transfer', 'type': 'PROCEDURE', 'description': 'Autologous fat transfer from abdomen to upper arms', 'armGroupLabels': ['Autologous fat transfer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90069', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Dr David Matlock', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sound Surgical Technologies, LLC.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'David Matlock', 'oldOrganization': 'Vaser HiDef Liposculpturing Institute of Beverly Hills'}}}}