Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-28 @ 7:31 AM
Study NCT ID:
NCT01093950
Status:
UNKNOWN
Last Update Posted:
2014-10-09
First Post:
2010-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
White Light Scanning to Aid Body Contouring: A Pilot Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008060', 'term': 'Lipodystrophy'}, {'id': 'D057215', 'term': 'Body Dysmorphic Disorders'}], 'ancestors': [{'id': 'D012875', 'term': 'Skin Diseases, Metabolic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013001', 'term': 'Somatoform Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-07', 'studyFirstSubmitDate': '2010-03-09', 'studyFirstSubmitQcDate': '2010-03-25', 'lastUpdatePostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To study whether the scanner was faster and more accurate than anthropometric measurements.', 'timeFrame': '9 months', 'description': 'The scanner and anthropometric measurements will be compared for accuracy and fidelity of collection. Anthropometric tape measurements will be compared to measurement extraction profiles provided by the scanner.Conclusions will be drawn based on the data collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anthropometric', 'white light scanner', 'extraction profiles', 'Body lipodystrophy'], 'conditions': ['Lipodystrophy', 'Body Dysmorphic Disorders']}, 'descriptionModule': {'briefSummary': 'A white light scanner can more accurately measure body contouring subjects than standard anthropomorphic methods.', 'detailedDescription': 'A 3-D digital body camera that employs non-intrusive white light phase profilometry and 24 coordinated charge-coupled cameras scans and produces a "point cloud" image of the subject. The result of the two-minute scan process is an accurate three-dimensional body model of the subject, consisting of over 1.2 million surface points. The point cloud is compressed to provide programmable measurement extraction profiles (MEP\'s) that automatically extracts linear and circumferential measurements. Subjects are scanned and anthropometrically measured pre-operatively, and at 3, 6 and 9 months post-op.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy, prospective, surgical candidates for body contouring surgery, including: lipoplasty, abdominoplasty, breast reduction, breast augmentation, thigh lift,and brachioplasty are being asked to participate in this research project.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All healthy preoperative body contouring subjects between 18-65 years old are potentially included in this study.\n\nExclusion Criteria:\n\n* Pregnant, nursing,or have a history of epilepsy.\n* Individuals under 18 years old;\n* Problems reading or understanding spoken instructions;\n* Are in jail or in a "locked ward";\n* Are a student or an employee of EVMS; or\n* Are chemically-dependent.'}, 'identificationModule': {'nctId': 'NCT01093950', 'briefTitle': 'White Light Scanning to Aid Body Contouring: A Pilot Project', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'White Light Scanning to Aid Body Contouring: A Pilot Project', 'orgStudyIdInfo': {'id': '05-09-FB-0235'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PROSPECTIVE BODY CONTOURING SUBJECTS', 'description': 'It is anticipated that the participants will undergo body contouring procedures including lipoplasty \\[internal fat suction removal\\], abdominoplasty \\[surgical removal of lower abdominal skin and fat\\], breast reduction \\[surgical removal of breast skin, fat, and breast tissue to reduce breast size\\], breast augmentation \\[surgical breast enlargement\\], thigh lift \\[surgical removal of upper thigh tissue\\], and brachioplasty \\[surgical removal of upper arm tissue\\].\n\nThese procedures will be evaluated by pre- and post-operative digital scans, analog measurements, and clinical examinations and photographs.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '23510', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David A Gilbert, MD', 'role': 'CONTACT', 'email': 'dagilb3@msn.com', 'phone': '757-274-4000'}, {'name': 'David A. Gilbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Hague Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'centralContacts': [{'name': 'DAVID A GILBERT, MD', 'role': 'CONTACT', 'email': 'Dagilb3@msn.com', 'phone': '757-274-4000'}, {'name': 'ROBERT H SCHNARRS, MD', 'role': 'CONTACT', 'email': 'HAGUE400@AOL.COM', 'phone': '757-274-4000'}], 'overallOfficials': [{'name': 'David A Gilbert, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Virginia Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novaptus Systems Incorporated', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David Gilbert', 'investigatorAffiliation': 'Eastern Virginia Medical School'}}}}