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

NCT04906811 | Terminated FDA Device

• 1 other identifier: AUGCS001
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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).

Conditions

Autologous Fat Grafting

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Patient Satisfaction

  3 months post-op

• Patient Satisfaction

  6 months post-op

• Patient Satisfaction

  12 months post-op

Study Arms (2)

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

ACTIVE COMPARATOR

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 with the Revolve System

ACTIVE COMPARATOR

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

Device: Revolve System (K120902)

Interventions

AuraGen 1-2-3 with AuraClens system (BK190433) DEVICE

Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system

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

Revolve System (K120902) DEVICE

Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System

Fat grafting with the Revolve System

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AuraGen Aesthetics LLC: lead

Study Sites (1)

Back Bay Plastic Surgery

Boston, Massachusetts, 02116, United States

Location

Study Officials

• Daniel A Del Vecchio, MD

  Back Bay Plastic Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 28, 2021
• Study Start: May 20, 2021
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)