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Recruiting NCT04891510

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

No phase Interventional Mastectomy Mammaplasty Breast Reconstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REVOLVE Advanced Adipose System, LipoGrafter, Viality.
Who it may be relevant to
Registry conditions: Mastectomy, Mammaplasty, Breast Reconstruction. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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).
  • 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).
  • 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.

Primary outcome measures

  • Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site [Time frame: Baseline, 90 day follow-up]
  • Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire [Time frame: Baseline, 90 day follow-up]
Secondary outcome measures (5)
  • Number of palpable masses from the fat grafting technique, as measured by a physical exam. [Time frame: 90 day follow-up]
  • Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam [Time frame: 90 day follow-up]
  • Presence of infection from the fat grafting technique, as measured by a physical exam [Time frame: 90 day follow-up]
  • Presence seroma from the fat grafting technique, as measured by a physical exam [Time frame: 90 day follow-up]
  • Assessment of wound healing from the fat grafting technique, as measured by a physical exam [Time frame: 90 day follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • New York Presbyterian - Weill Cornell Medicine — New York

Identifiers

NCT: NCT04891510 · 20-10022850

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗