Recruiting

REVOLVE, LipoGrafter, Viality

Sponsor:

Weill Medical College of Cornell University

Code:

NCT04891510

Conditions

Mastectomy

Mammaplasty

Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REVOLVE Advanced Adipose System

LipoGrafter

Viality

Study Details

Brief summary:

The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.

Conditions

Mastectomy

Mammaplasty

Breast Reconstruction

Study ID

NCT04891510

Start date

May 19, 2021

Status verified date

Jun, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Female;
  • Documented history of previous breast surgery (either complete or partial mastectomy);
  • Available harvest sites for fat grafting as documented by plastic surgeon;
  • BMI > 20;
  • Anticipated harvested fat volume > 50cc;
  • Competency and willingness to provide consent

Exclusion Criteria:

  • Suspected or known to be pregnant

Study Design

Enrollment

135 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: REVOLVE Advanced Adipose System

Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.

active comparator: LipoGrafter

Participants will receive the LipoGrafter technique during breast reconstruction.

active comparator: Viality

Participants will receive the Viality technique during breast reconstruction.

Interventions

REVOLVE Advanced Adipose System

The REVOLVE system is an all-in-one fat processing device that harvests, filters, actively washes, and removes strands from lipoaspirate and allows for reinjection without any additional manipulation (REVOLVE 2020).

LipoGrafter

The LipoGrafter system is designed to be a start-to-finish closed system with minimal processing of the lipoaspirate, minimizing the risk of contamination and fat cell damage (LipoGrafter 2020).

Viality

The Viality system uses the AuraClens solution that acts as a surfactant to bring impurities like blood, free oil, and cellular debris into solution, where they can be flushed out through suction.

Primary outcome measure

  • Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site [ Time Frame: Baseline, 90 day follow-up ]
  • Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire [ Time Frame: Baseline, 90 day follow-up ]

Central Contacts and Locations

Central contacts

Michael B Amrami, MPH

646-544-7658mia7046@med.cornell.edu

Daana Bajnauth

646-789-1447dab4001@med.cornell.edu

Locations

New York Presbyterian - Weill Cornell Medicine

Recruiting

New York, New York, United States, 10021

Contacts

Michael B Amrami, MPH

646-544-7658mia7046@med.cornell.edu

Daana Bajnauth

646-789-1447dab4001@med.cornell.edu

More Information

Sponsor

Weill Medical College of Cornell University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Weill Medical College of Cornell University on 2026-06-22.