RecruitingNot ApplicableNCT04891510

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


Sponsor

Weill Medical College of Cornell University

Enrollment

135 participants

Start Date

May 19, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria6

  • 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 Criteria1

  • Suspected or known to be pregnant

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Interventions

DEVICEREVOLVE 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).

DEVICELipoGrafter

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).

PROCEDUREViality

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.


Locations(1)

New York Presbyterian - Weill Cornell Medicine

New York, New York, United States

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NCT04891510


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