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

Stopped early · Not applicable

Conditions studied: Autologous Fat Grafting

In brief

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).

Key facts

Study ID

NCT04906811

Run by

AuraGen Aesthetics LLC

People needed

17

Starts

2021-05-20

Expected to finish

2024-02-12

Last updated by the study team

2024-02-14

Who can join

Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Pregnant or breastfeeding.
• Any issue that, at the discretion of the investigator, would contraindicate the patient's participation.
• Patients who do not wish to have the study area (breast) photographed
• NOTE Please note that there is no remuneration for participation in this study.

Where it is running

• Back Bay Plastic Surgery — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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