Autologous Fat Grafting
Conditions
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.
Interventions
DEVICEAuraGen 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
DEVICERevolve System (K120902)
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System
Sponsors
AuraGen Aesthetics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 12 months post-op | 12 months post-op | Measurement of volume of fat graft at 6 months post-op, using 3D photography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 3 months post-op | Breast-Q - Augmentation Survey |
Countries
United States
Outcome results
None listed