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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Reconstruction; Mastectomy; Mammaplasty
• Intervention / Treatment: Device: REVOLVE Advanced Adipose System; Device: LipoGrafter; Procedure: Viality

• Study Type: Interventional
• Enrollment (Estimated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Makayla Kochheiser; Phone Number: 740.816.9707; Email: mlk4002@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • New York Presbyterian - Weill Cornell Medicine
      • Contact: Yunchan Chen; Phone Number: 858.997.6026; Email: yuc4005@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: REVOLVE Advanced Adipose System; Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.	Device: 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).
Active Comparator: LipoGrafter; Participants will receive the LipoGrafter technique during breast reconstruction.	Device: 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).
Active Comparator: Viality; Participants will receive the Viality technique during breast reconstruction.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of palpable masses from the fat grafting technique, as measured by a physical exam.	The physical exam will provide the number of palpable masses at the surgical site.	90 day follow-up
Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam	The physical exam will provide the number of lesions of probable fat necrosis at the surgical site	90 day follow-up
Presence of infection from the fat grafting technique, as measured by a physical exam	The physical exam will show if there is infection present at the surgical site. This is a binary "yes/no" item.	90 day follow-up
Presence seroma from the fat grafting technique, as measured by a physical exam	The physical exam will show if there is seroma present at the surgical site. This is a binary "yes/no" item.	90 day follow-up
Assessment of wound healing from the fat grafting technique, as measured by a physical exam	The physical exam will show if wound healing is normal or delayed at the surgical site. This is a binary "normal/delayed" item.	90 day follow-up

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: David Otterburn, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20-10022850

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes