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

17 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two systems for preparing fat for breast injections. It targets patients having fat grafting without implants. The goal is to see which system helps the fat stay in place better.

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 data supports the effectiveness of the treatment AuraGen 1-2-3 with AuraClens system for breast enhancement?

Research shows that using autologous fat grafting (transferring a person's own fat) for breast reconstruction can improve aesthetic outcomes and patient satisfaction. Studies have demonstrated that this method can lead to long-term improvements in breast size and shape, as well as enhance quality of life by boosting self-confidence and body acceptance. ^{1 2 3 4 5}

How is the AuraGen 1-2-3 with AuraClens system treatment for breast enhancement different from other treatments?

The AuraGen 1-2-3 with AuraClens system is unique because it involves fat grafting, which uses the patient's own fat to enhance breast volume, potentially offering a more natural look and feel compared to synthetic implants. This method may also reduce the risk of rejection or allergic reactions since it uses the body's own tissue. ^{6 7 8 9 10}

Research Team

Daniel A Del Vecchio, MD

Principal Investigator

Back Bay Plastic Surgery

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Total breast reconstruction using large-volume condensed and viable fat grafting after mastectomy. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Better clinical outcome for autologous fat transplant combined with silicone gel prosthesis for breast augmentation: Evidence from meta-analysis. [2020]

3. Germany pubmed.ncbi.nlm.nih.gov

Long-term clinical results and quality of life in patients undergoing autologous fat transplantation for breast augmentation using the BEAULI™ protocol. [2020]

4. China pubmed.ncbi.nlm.nih.gov

[Research progress of external volume expansion assisted autologous fat grafting for breast reconstruction]. [2022]

5. Sweden pubmed.ncbi.nlm.nih.gov

Using an external soft tissue expander before autologous fat grafting for non-irradiated breast reconstruction. [2013]

6. Germany pubmed.ncbi.nlm.nih.gov

Hand augmentation with stabilized hyaluronic acid (Macrolane VRF20 and Restylane Vital, Restylane Vital Light). [2022]

7. England pubmed.ncbi.nlm.nih.gov

Luting composite thickness of two ceramic inlay systems. [2015]

8. Germany pubmed.ncbi.nlm.nih.gov

Clinical Performance of Bulk-Fill Resin Composite Restorations Using the United States Public Health Service and Federation Dentaire Internationale Criteria: A 12-Month Randomized Clinical Trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of class II Targis inlays: preliminary results after 1 year. [2019]

10. India pubmed.ncbi.nlm.nih.gov

The comparative evaluation of depth of cure of bulk-fill composites - An in vitro study. [2022]