NCT04891510

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (estimated)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastectomy
• Mammaplasty
• Breast Reconstruction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-05-19
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2021-05-18
• Last updated: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study