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Comparing Fat Grafting Methods for Breast Reconstruction

This study is comparing three different methods for processing fat used in breast reconstruction surgery after a mastectomy (removal of the breast) or mammaplasty (breast reshaping). The methods are REVOLVE, LipoGrafter, and Viality. Researchers want to see which method helps the fat grafts last longer and leads to better patient satisfaction. You may be able to join if you are a woman, at least 18 years old, have had previous breast surgery, have enough fat for grafting, and a BMI (Body Mass Index) over 20. The study will measure how well the fat grafts work using 3D scans and your satisfaction with a special questionnaire. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 135 women. It compares three different device-based fat processing methods.
What's involved
Your fat grafting technique will be measured at the start of the study and again 90 days later. You will also complete a satisfaction questionnaire at these times.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 90 days after their fat grafting procedure to assess efficacy and satisfaction.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04891510

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

Recruiting
NAAges 18+InterventionalTreatment
Weill Medical College of Cornell University
~135 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:REVOLVE Advanced Adipose SystemLipoGrafterViality

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site
Measured over Baseline, 90 day follow-up
+1 more outcome measured

Conditions

Mastectomy
Mammaplasty
Breast Reconstruction

Explore related trials

MammoplastyMastectomy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • David Otterburn, MD · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Michael B Amrami, MPH
[email protected]
646-544-7658
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Suspected or known to be pregnant

What this trial measures

  • Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical siteBaseline, 90 day follow-up

    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.

  • Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaireBaseline, 90 day follow-up

    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.