Status:
TERMINATED
Prospective Comparison of Revolve™ and AuraGen 123 With AuraClens™ in Autologous Fat Grafting to the Breast
Lead Sponsor:
AuraGen Aesthetics LLC
Conditions:
Autologous Fat Grafting
Eligibility:
FEMALE
18-65 years
Phase:
NA
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 Lipoa...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 12 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04906811
Start Date
May 20 2021
End Date
February 12 2024
Last Update
February 14 2024
Active Locations (1)
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1
Back Bay Plastic Surgery
Boston, Massachusetts, United States, 02116