The Volumetric Analysis of Fat Grafting

NCT03544593 | Unknown FDA Device

• 1 other identifier: 11-01-2017
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autologous Fat Grafting

Outcome Measures

Primary Outcomes (1)

• Graft retention

  Vectra 3D volumetric analysis will be utilized to evaluate graft retention.

  9 months

Secondary Outcomes (4)

• 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

Interventions

Revolve System DEVICE

Fat grafting system

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hunstad Kortesis Bharti Cosmetic Sugrery: lead
• Allergan: collaborator

Study Sites (1)

Kelly Costin

Huntersville, North Carolina, 28078, United States

RECRUITING

Study Officials

• Kelly Costin, RN, BSN

  Hunstad Kortesis Bharti Cosmetic Surgery

  STUDY DIRECTOR

Central Study Contacts

Kelly Costin, RN, BSN

CONTACT

7046599000; kelly.c@hkbsurgery.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 4, 2018
• Study Start: January 4, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: June 4, 2018

Record last verified: 2018-05

Locations

US (1)