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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04891510
Status
Recruiting
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Conditions

  • Breast Reconstruction
  • Mammaplasty
  • Mastectomy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • 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.

Study Details

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.

Key Dates

First listed
May 18, 2021
Start date
May 19, 2021
Status verified
Jun 2026
Primary completion
Jun 1, 2028
Completion
Jun 1, 2028

Study Design

Enrollment
135 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
New York Presbyterian - Weill Cornell MedicineNew YorkNew York10021
Michael B Amrami, MPH
[email protected]
646-544-7658
Daana Bajnauth
[email protected]
646-789-1447

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By research site
New York Presbyterian - Weill Cornell Medicine· New York, NY

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