The Volumetric Analysis of Fat Grafting

Last updated: May 21, 2018
Sponsor: Hunstad Kortesis Bharti Cosmetic Sugrery
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03544593
11-01-2017
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Pregnancy, currently breast feeding or planning pregnancy for the duration of thetrial

  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 systemicdisease 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 aplatelet 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 studyin a drug or other investigational research study.

Study Design

Total Participants: 50
Study Start date:
January 04, 2018
Estimated Completion Date:
March 31, 2019

Connect with a study center

  • Kelly Costin

    Huntersville, North Carolina 28078
    United States

    Active - Recruiting

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