The Volumetric Analysis of Fat Grafting

The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring

Title: The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring.

Subjects 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.

Study Overview

• Status: Unknown
• Conditions: Autologous Fat Grafting
• Intervention / Treatment: Device: Revolve System

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Recruiting
      • Kelly Costin
      • Contact: Kelly Costin, RN, BSN; Phone Number: 704-659-9000; Email: kelly.c@hkbsurgery.com
      • Principal Investigator: Bill G Kortesis, MD
      • Sub-Investigator: Joseph P Hunstad, MD
      • Sub-Investigator: Gaurav Bharti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Females or Males in good general health age 18 - 65 years of age
2. Must be willing to give and sign a HIPAA form and informed consent form
3. Must be willing and able to comply with all study protocols and schedules
4. Negative urine pregnancy test prior to surgery treatment (if applicable)
5. 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

Exclusion Criteria:

1. Pregnancy, currently breast feeding or planning pregnancy for the duration of the trial
2. History of breast cancer if fat grafting to breasts
3. Patients who smoke or use nicotine products
4. 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
5. Diabetes Mellitus
6. 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
7. Patients under the age of 18
8. Patients undergoing fat grafting but refuse enrollment
9. Patients with an active infection
10. Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Graft retention	Vectra 3D volumetric analysis will be utilized to evaluate graft retention.	9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Volume of adipose harvested (mL)	Intra Op
Volume of adipocyte injected (mL)	Intra Op
Operating room time (harvesting, processing, and reinjection time) (min)	Intra Op
Standardized before and after photos	Pre op, 3 months, 6 months, 9 months

Collaborators and Investigators

• Sponsor: Hunstad Kortesis Bharti Cosmetic Sugrery
• Collaborators: Allergan
• Investigators: Study Director: Kelly Costin, RN, BSN, Hunstad Kortesis Bharti Cosmetic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: May 8, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): June 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 21, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 11-01-2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes