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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prospective Comparison of the Revolve™ and AuraGen 1-2-3™ With AuraClens™ Systems in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast

Conditions
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Autologous Fat Grafting

Intervention / Treatment
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* Device: AuraGen 1-2-3 with AuraClens system (BK190433)
* Device: Revolve System (K120902)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fat grafting with the AuraGen 1-2-3 with AuraClens System<br>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. | Device: AuraGen 1-2-3 with AuraClens system (BK190433)<br>* Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system<br>|
| Active Comparator: Fat grafting with the Revolve System<br>Patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. Lipoaspirate processed with the Revolve System. | Device: Revolve System (K120902)<br>* Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat volume retention at 3 months post-op | Measurement of volume of fat graft at 3 months post-op, using 3D photography | 3 months post-op | 
| Fat volume retention at 6 months post-op | Measurement of volume of fat graft at 6 months post-op, using 3D photography | 6 months post-op | 
| Fat volume retention at 12 months post-op | Measurement of volume of fat graft at 6 months post-op, using 3D photography | 12 months post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction | Breast-Q - Augmentation Survey | 3 months post-op | 
| Patient Satisfaction | Breast-Q - Augmentation Survey | 6 months post-op | 
| Patient Satisfaction | Breast-Q - Augmentation Survey | 12 months post-op |