Clinical trial NCT04906811: Prospective Comparison of Revolve™ and AuraGen 123 With AuraClens™ in Autologous Fat Grafting to the Breast
Official title: Prospective Comparison of the Revolve™ and AuraGen 1-2-3™ With AuraClens™ Systems in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autologous Fat Grafting
Lead sponsor: AuraGen Aesthetics LLC
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fat volume retention at 3 months post-op
timeFrame: 3 months post-op
measure: Fat volume retention at 6 months post-op
timeFrame: 6 months post-op
measure: Fat volume retention at 12 months post-op
timeFrame: 12 months post-op
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 3 months post-op
measure: Patient Satisfaction
timeFrame: 6 months post-op
measure: Patient Satisfaction
timeFrame: 12 months post-op
Other outcomes:
Locations:
city: Boston
country: United States
facility: Back Bay Plastic Surgery
state: Massachusetts
Study officials:
affiliation: Back Bay Plastic Surgery
name: Daniel A Del Vecchio, MD
role: PRINCIPAL_INVESTIGATOR
References: