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NCT Number: NCT04891510

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.

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Key information

Conditions

Mastectomy Breast Reconstruction Mammaplasty

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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).

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.

Primary outcomes

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

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

Secondary outcomes

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

    Time frame: 90 day follow-up

    The physical exam will provide the number of palpable masses at the surgical site.

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

    Time frame: 90 day follow-up

    The physical exam will provide the number of lesions of probable fat necrosis at the surgical site

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

    Time frame: 90 day follow-up

    The physical exam will show if there is infection present at the surgical site. This is a binary "yes/no" item.

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

    Time frame: 90 day follow-up

    The physical exam will show if there is seroma present at the surgical site. This is a binary "yes/no" item.

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

    Time frame: 90 day follow-up

    The physical exam will show if wound healing is normal or delayed at the surgical site. This is a binary "normal/delayed" item.

Study contacts

Contact information is provided by the study sponsor or research team.

Daana Bajnauth

CONTACT

[email protected]

646-789-1447

Michael B Amrami, MPH

CONTACT

[email protected]

646-544-7658

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
May 18, 2021
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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