Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT03544593
Status:
UNKNOWN
Last Update Posted:
2018-06-04
First Post:
2018-05-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Volumetric Analysis of Fat Grafting
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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-21', 'studyFirstSubmitDate': '2018-05-08', 'studyFirstSubmitQcDate': '2018-05-21', 'lastUpdatePostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Graft retention', 'timeFrame': '9 months', 'description': 'Vectra 3D volumetric analysis will be utilized to evaluate graft retention.'}], 'secondaryOutcomes': [{'measure': 'Volume of adipose harvested (mL)', 'timeFrame': 'Intra Op'}, {'measure': 'Volume of adipocyte injected (mL)', 'timeFrame': 'Intra Op'}, {'measure': 'Operating room time (harvesting, processing, and reinjection time) (min)', 'timeFrame': 'Intra Op'}, {'measure': 'Standardized before and after photos', 'timeFrame': 'Pre op, 3 months, 6 months, 9 months'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Autologous Fat Grafting']}, 'descriptionModule': {'briefSummary': 'Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring.\n\nSubjects who wish to undergo fat grafting for aesthetic body contouring will be offered enrollment to the study. The study will consist of a Screening/Baseline visit, Surgery day and 3 follow up visits. Each follow up visit will utilize Vectra 3D photography (Canfeild, NJ) to collect volumetric data. At the conclusion of the study, Volume data from Baseline and 3 follow up visits will be analyzed to determine fat retention rates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Females or Males in good general health age 18 - 65 years of age\n2. Must be willing to give and sign a HIPAA form and informed consent form\n3. Must be willing and able to comply with all study protocols and schedules\n4. Negative urine pregnancy test prior to surgery treatment (if applicable)\n5. The patient must have had a stable weight (no fluctuation of \\>15 pounds in a year), diet, and physical activity for the previous 6 months\n\nExclusion Criteria:\n\n1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial\n2. History of breast cancer if fat grafting to breasts\n3. Patients who smoke or use nicotine products\n4. Any UNCONTROLLED systemic disease -a potential patient in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study\n5. Diabetes Mellitus\n6. Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \\< 100,000 per microliter or International Normalized Ratio \\> 1.5 within 4 weeks of surgery\n7. Patients under the age of 18\n8. Patients undergoing fat grafting but refuse enrollment\n9. Patients with an active infection\n10. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.'}, 'identificationModule': {'nctId': 'NCT03544593', 'briefTitle': 'The Volumetric Analysis of Fat Grafting', 'organization': {'class': 'OTHER', 'fullName': 'Hunstad Kortesis Bharti Cosmetic Sugrery'}, 'officialTitle': 'The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring', 'orgStudyIdInfo': {'id': '11-01-2017'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Revolve System', 'type': 'DEVICE', 'description': 'Fat grafting system'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28078', 'city': 'Huntersville', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Costin, RN, BSN', 'role': 'CONTACT', 'email': 'kelly.c@hkbsurgery.com', 'phone': '704-659-9000'}, {'name': 'Bill G Kortesis, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Joseph P Hunstad, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gaurav Bharti, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kelly Costin', 'geoPoint': {'lat': 35.41069, 'lon': -80.84285}}], 'centralContacts': [{'name': 'Kelly Costin, RN, BSN', 'role': 'CONTACT', 'email': 'kelly.c@hkbsurgery.com', 'phone': '7046599000'}], 'overallOfficials': [{'name': 'Kelly Costin, RN, BSN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hunstad Kortesis Bharti Cosmetic Surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hunstad Kortesis Bharti Cosmetic Sugrery', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Bill G Kortesis, MD', 'investigatorAffiliation': 'Hunstad Kortesis Bharti Cosmetic Sugrery'}}}}