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Prospective Comparison of Revolve™ and AuraGen 123 With AuraClens™ in Autologous Fat Grafting to the Breast | Clinical Trials | Clareo Health

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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

NCT04906811•AuraGen Aesthetics LLC

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•Female patients \> 18 years and \< 65 years of age
•Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) without a breast implant.
•Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits.
•Patients must be non-smokers.
•Patients with available/adequate harvest sites for fat grafting.
•Anticipated harvested fat volume between 400 and 1400 cc
•Anticipated fat injection volume 150-350 cc per breast
•Patients must agree to maintain their weight (i.e. within 5%) by not making any major changes in their diet or lifestyle during the study.

Exclusion Criteria

•Skin rash in the treatment area.
•Patients who smoke or use nicotine products.
•Patients with bleeding disorders or currently taking anticoagulants.
•Patients with a history of trauma or surgery to the treatment area.
•Patients with a history of breast cancer.
•Active, chronic, or recurrent infection.
•Compromised immune system (e.g. diabetes).
•Hypersensitivity to analgesic agents.
•Co-morbid conditions that could limit their ability to participate in the study or to comply with follow-up requirements.
•Untreated drug and/or alcohol abuse.
+4 more criteria

Locations (1)

Back Bay Plastic Surgery

Boston, Massachusetts, United States

Key Dates

Start Date

May 20, 2021

Primary Completion Date

February 12, 2024

Completion Date

February 12, 2024

Last Updated

February 14, 2024

Enrollment

ACTUAL participants

Conditions

Autologous Fat Grafting

Interventions

AuraGen 1-2-3 with AuraClens system (BK190433)

DEVICE

Revolve System (K120902)

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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