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

AuraGen Aesthetics

Status: Terminated

Conditions: Autologous Fat Grafting

Treatments: Device: Revolve System (K120902); Device: AuraGen 1-2-3 with AuraClens system (BK190433)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04906811

AUGCS001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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17 participants in 2 patient groups

Fat grafting with the AuraGen 1-2-3 with AuraClens System

Active Comparator group

Description:

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.

Treatment:

Device: AuraGen 1-2-3 with AuraClens system (BK190433)

Fat grafting with the Revolve System

Active Comparator group

Description:

Patients undergoing an aesthetic fat grafting procedure to the breast without a breast implant. Lipoaspirate processed with the Revolve System.

Treatment:

Device: Revolve System (K120902)