Prospective Comparison of Revolve™ and AuraGen 123 With AuraClens™ in Autologous Fat Grafting to the Breast
- Conditions
- Autologous Fat Grafting
- Interventions
- Device: AuraGen 1-2-3 with AuraClens system (BK190433)Device: Revolve System (K120902)
- Registration Number
- NCT04906811
- Lead Sponsor
- AuraGen Aesthetics LLC
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 17
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Fat grafting with the AuraGen 1-2-3 with AuraClens System AuraGen 1-2-3 with AuraClens system (BK190433) Patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. Lipoaspirate processed with the AuraGen 1-2-3 with AuraClens system. Fat grafting with the Revolve System Revolve System (K120902) Patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. Lipoaspirate processed with the Revolve System.
- Primary Outcome Measures
Name Time Method Fat volume retention at 6 months post-op 6 months post-op Measurement of volume of fat graft at 6 months post-op, using 3D photography
Fat volume retention at 3 months post-op 3 months post-op Measurement of volume of fat graft at 3 months post-op, using 3D photography
Fat volume retention at 12 months post-op 12 months post-op Measurement of volume of fat graft at 6 months post-op, using 3D photography
- Secondary Outcome Measures
Name Time Method Patient Satisfaction 12 months post-op Breast-Q - Augmentation Survey
Trial Locations
- Locations (1)
Back Bay Plastic Surgery
🇺🇸Boston, Massachusetts, United States