A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

NCT04891510 | Recruiting DMC FDA Device

• 1 other identifier: 20-10022850
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site

  3D volumetric scanning assesses the fat graft retention defined as the ratio of fat remaining at the surgical site at 90 day follow-up to that at pre-operative baseline.

  Baseline, 90 day follow-up

• Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire

  The BREAST-Q questionnaire is used for measuring pre- and postoperative psychosocial, physical, and sexual well-being, satisfaction with breasts, experience of care, and satisfaction with outcome. Scores range on a 0-100 scale, with higher scores indicating better outcomes.

  Baseline, 90 day follow-up

Secondary Outcomes (5)

• Number of palpable masses from the fat grafting technique, as measured by a physical exam.

  90 day follow-up

• Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam

  90 day follow-up

• Presence of infection from the fat grafting technique, as measured by a physical exam

  90 day follow-up

• Presence seroma from the fat grafting technique, as measured by a physical exam

  90 day follow-up

• Assessment of wound healing from the fat grafting technique, as measured by a physical exam

  90 day follow-up

Study Arms (3)

REVOLVE Advanced Adipose System

ACTIVE COMPARATOR

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

Device: REVOLVE Advanced Adipose System

LipoGrafter

ACTIVE COMPARATOR

Participants will receive the LipoGrafter technique during breast reconstruction.

Device: LipoGrafter

Viality

ACTIVE COMPARATOR

Participants will receive the Viality technique during breast reconstruction.

Procedure: Viality

Interventions

REVOLVE Advanced Adipose System DEVICE

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).

REVOLVE Advanced Adipose System

LipoGrafter DEVICE

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).

LipoGrafter

Viality PROCEDURE

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.

Viality

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Suspected or known to be pregnant

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

New York Presbyterian - Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Study Officials

• David Otterburn, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Makayla Kochheiser

CONTACT

740.816.9707; mlk4002@med.cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 18, 2021
• Study Start: May 19, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)