Fat Grafting Devices for Breast Enhancement

Overseen By Yiannis Monovoukas, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: AuraGen Aesthetics LLC

Must not be taking: Anticoagulants

Disqualifiers: Smoking, Breast cancer, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well two devices, the AuraGen 1-2-3 with AuraClens system and the Revolve System, retain fat in the breast after a fat grafting procedure. Researchers seek to determine which device is more effective for breast enhancement without implants. Ideal participants are women planning to undergo fat grafting for breast augmentation, who do not smoke, and can maintain stable weight during the study. As an unphased trial, this study allows participants to contribute to innovative research in breast enhancement techniques.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking anticoagulants (blood thinners).

What prior data suggests that these fat grafting devices are safe for breast enhancement?

Research has shown that both the AuraGen 1-2-3 with AuraClens system and the Revolve System safely perform fat grafting procedures. The AuraGen system creates fat grafts with healthy cells that last a long time, making it generally well-tolerated with few problems.

Studies have found that the Revolve System leads to fewer issues, such as small lumps or cysts, compared to other methods. It also reduces the need for additional surgeries to add extra fat, making it a safe and effective choice for breast reconstruction.

Both systems have FDA approval, indicating they meet safety standards for certain procedures. This approval suggests these devices are safe options for fat grafting to the breast. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they explore innovative ways to enhance breast appearance using fat grafting instead of traditional implants or fillers. The AuraGen 1-2-3 with AuraClens system and the Revolve System both aim to refine fat grafting by processing the patient's own fat, making the procedure feel more natural and potentially reducing rejection risks. These systems promise more precise and cleaner fat transfer, which could lead to better outcomes in terms of aesthetics and safety compared to existing methods. This approach opens the door to a more personalized and potentially safer option for breast enhancement.

What evidence suggests that these fat grafting devices are effective for breast enhancement?

In this trial, participants will undergo fat grafting using either the AuraGen 1-2-3 with AuraClens system or the Revolve System. Research has shown that the AuraGen 1-2-3 with AuraClens system retains more transferred fat over time and creates fat grafts with healthy cells, resulting in better and longer-lasting outcomes. In contrast, the Revolve System reduces the risk of small lumps and cysts compared to other methods and speeds up the procedure by transferring fat more efficiently. Both systems show promise in creating stable and long-lasting fat grafts, making them effective options for breast enhancement through fat grafting. ^{1 2 3 4 5}

Who Is on the Research Team?

Daniel A Del Vecchio, MD

Principal Investigator

Back Bay Plastic Surgery

Are You a Good Fit for This Trial?

This trial is for women aged 18-65 planning to undergo fat grafting to the breast without implants. They must be non-smokers with a stable weight, able to give consent and follow study procedures. Excluded are those with skin rashes, bleeding disorders, past breast trauma or cancer, infections, compromised immune systems, untreated substance abuse issues, or pregnancy.

Inclusion Criteria

I am having a breast fat grafting procedure without an implant.

I am a woman aged between 18 and 65.

Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits

Exclusion Criteria

Untreated drug and/or alcohol abuse

I have a condition like diabetes that weakens my immune system.

I have an ongoing or recurring infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an aesthetic fat grafting procedure to the breast using either the Revolve System or the AuraGen 1-2-3 with AuraClens system

1 day

1 visit (in-person)

Follow-up

Participants are monitored for fat graft retention and patient satisfaction at 3, 6, and 12 months post-procedure

12 months

3 visits (in-person) at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• AuraGen 1-2-3 with AuraClens system (BK190433)
• Revolve System (K120902)

Trial Overview The study aims to compare the effectiveness of two FDA-cleared devices in preserving fat grafts: Revolve System and AuraGen 1-2-3 with AuraClens system. It will monitor how well each device maintains transferred fat over time after aesthetic breast augmentation.

How Is the Trial Designed?

Group I: Fat grafting with the AuraGen 1-2-3 with AuraClens System Active Control 1 Intervention

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.

Group II: Fat grafting with the Revolve System Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

AuraGen Aesthetics LLC

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05258305

AuraClens™ System in Processing of Lipoaspirate for ... Prospective Study on Fat Retention When Using the AuraGen 1-2-3™ With AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04906811

Study Details | NCT04906811 | Prospective Comparison of ... 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.

3. withpower.com withpower.com/trial/phase-4-2021-c07da

Fat Grafting Devices for Breast Enhancement Trial Overview The study aims to compare the effectiveness of two FDA-cleared devices in preserving fat grafts: Revolve System and AuraGen 1-2-3 with AuraClens ...

4. investors.sientra.com investors.sientra.com/news/news-details/2022/Sientra-Announces-Acquisition-of-Novel-Fat-Grafting-Technology-from-AuraGen-Aesthetics-LLC/default.aspx

Sientra Announces Acquisition of Novel Fat Grafting ... “AuraGen's transformative fat grafting system will provide us with a unique platform to not only grow our total market share within breast ...

5. sec.gov sec.gov/Archives/edgar/data/1551693/000095017022005233/sien-20211231.htm

10-K The AuraGen fat grafting technology has been shown to produce fat grafts with high fat concentration, high cell viability, and high retention rates in both in ...