NCT04906811

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

Prospective Comparison of the Revolve™ and AuraGen 1-2-3™ With AuraClens™ Systems in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: AuraGen Aesthetics LLC · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Autologous Fat Grafting

Interventions

Type	Name	Description
DEVICE	AuraGen 1-2-3 with AuraClens system (BK190433)	Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system
DEVICE	Revolve System (K120902)	Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System

Timeline

• Start date: 2021-05-20
• Primary completion: 2024-02-12
• Completion: 2024-02-12
• First posted: 2021-05-28
• Last updated: 2024-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study