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

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

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).

Study Overview

• Status: Terminated
• Conditions: Autologous Fat Grafting
• Intervention / Treatment: Device: AuraGen 1-2-3 with AuraClens system (BK190433); Device: Revolve System (K120902)

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.

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02116
      • Back Bay Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: AuraGen Aesthetics LLC
• Investigators: Principal Investigator: Daniel A Del Vecchio, MD, Back Bay Plastic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2021
• Primary Completion (Actual): February 12, 2024
• Study Completion (Actual): February 12, 2024

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 28, 2021

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: AUGCS001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Both devices are FDA-cleared. This is a marketing study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No