The Volumetric Analysis of Fat Grafting

Autologous Fat Grafting Clinical Trial

Official title:

The Volumetric Analysis of Fat Grafting for Aesthetic Body Contouring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544593
• Other study ID #: 11-01-2017
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2018
• Est. completion date: March 2019

Study information

• Verified date: May 2018
• Source: Hunstad Kortesis Bharti Cosmetic Sugrery
• Contact: Kelly Costin, RN, BSN
• Phone: 7046599000
• Email: kelly.c[@]hkbsurgery.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autologous Fat Grafting

Intervention

Device:
• Revolve System
Fat grafting system

Locations

Country	Name	City	State
United States	Kelly Costin	Huntersville	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Hunstad Kortesis Bharti Cosmetic Sugrery	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Graft retention	Vectra 3D volumetric analysis will be utilized to evaluate graft retention.	9 months
Secondary	Volume of adipose harvested (mL)		Intra Op
Secondary	Volume of adipocyte injected (mL)		Intra Op
Secondary	Operating room time (harvesting, processing, and reinjection time) (min)		Intra Op
Secondary	Standardized before and after photos		Pre op, 3 months, 6 months, 9 months