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

Autologous Fat Grafting Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04906811
• Other study ID #: AUGCS001
• Status: Terminated
• Phase: N/A
• Start date: May 20, 2021
• Est. completion date: February 12, 2024

Study information

• Verified date: February 2024
• Source: AuraGen Aesthetics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: February 12, 2024
• Est. primary completion date: February 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autologous Fat Grafting

Intervention

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
• Revolve System (K120902)
Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System

Locations

Country	Name	City	State
United States	Back Bay Plastic Surgery	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AuraGen Aesthetics LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Patient Satisfaction	Breast-Q - Augmentation Survey	3 months post-op
Secondary	Patient Satisfaction	Breast-Q - Augmentation Survey	6 months post-op
Secondary	Patient Satisfaction	Breast-Q - Augmentation Survey	12 months post-op