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Status unknownNCT03544593Updated Jun 4, 2018

The Volumetric Analysis of Fat Grafting

An interventional study of Revolve System in Autologous Fat Grafting, sponsored by Hunstad Kortesis Bharti Cosmetic Sugrery. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-04.

Sponsored by Hunstad Kortesis Bharti Cosmetic Sugrery · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Jan 2018, registered May 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Autologous Fat Grafting
03

In context

Lead sponsor

This is the only study on the registry with Hunstad Kortesis Bharti Cosmetic Sugrery as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • DeviceRevolve System

    Fat grafting system

06

What researchers measure

Primary outcomes

  1. Graft retention

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

    Time frame: 9 months

Secondary outcomes

  1. Volume of adipose harvested (mL)

    Time frame: Intra Op

  2. Volume of adipocyte injected (mL)

    Time frame: Intra Op

  3. Operating room time (harvesting, processing, and reinjection time) (min)

    Time frame: Intra Op

  4. Standardized before and after photos

    Time frame: Pre op, 3 months, 6 months, 9 months

07

Study locations

1 of 1 sites recruiting
  • Kelly Costin
    Huntersville, North Carolina 28078, United States
    • Kelly Costin, RN, BSN · Contact · kelly.c@hkbsurgery.com · 704-659-9000
    • Bill G Kortesis, MD · Principal investigator
    • Joseph P Hunstad, MD · Sub investigator
    • Gaurav Bharti, MD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03544593
Lead sponsor
Hunstad Kortesis Bharti Cosmetic Sugrery
Collaborators
Allergan
Responsible party
Bill G Kortesis, MD (PI, Hunstad Kortesis Bharti Cosmetic Sugrery) — Principal investigator
First posted
Jun 4, 2018
Start date
Jan 4, 2018
Primary completion
Mar 2019 (estimated)
Completion
Mar 2019 (estimated)
Last update
Jun 4, 2018

Study contacts

Kelly Costin, RN, BSN
Contact
kelly.c@hkbsurgery.com
7046599000
Kelly Costin, RN, BSN
study director · Hunstad Kortesis Bharti Cosmetic Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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