Prospective Comparison of Revolve and AuraGen 123 With AuraClens in Autologous Fat Grafting to the Breast

  • STATUS
    Recruiting
  • participants needed
    20
  • sponsor
    AuraGen Aesthetics LLC
Updated on 5 February 2023

Summary

The purpose of this study is to compare fat graft retention over time from lipoaspirate processed using two FDA-cleared devices: the Revolve System (K120902) and the AuraGen 1-2-3 with AuraClens Lipoaspirate Wash System (BK190433).

Description

This is a single-center, prospective, randomized study enrolling patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. A total of 20 patients will be enrolled in the study. Ten patients will receive lipoaspirate processed with the Revolve and ten patients will have lipoaspirate processed with the AuraGen 1-2-3 with AuraClens.

Patients will be followed on post-procedure months 3, 6, and 12. Fat graft retention will be evaluated by photographic assessment by blinded reviewers, and 3D imaging. Patient satisfaction will be measured using the Breast-Q - Augmentation survey.

Details
Condition Autologous Fat Grafting
Treatment AuraGen 1-2-3 with AuraClens system (BK190433), Revolve System (K120902)
Clinical Study IdentifierNCT04906811
SponsorAuraGen Aesthetics LLC
Last Modified on5 February 2023

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