What side effects are associated with this type of intervention?

Common side effects of autologous fat transfer treatments, including those processed with systems like the Revolve and AuraGen 1-2-3 with AuraClens, typically include swelling, bruising, and temporary discomfort at both the donor and recipient sites. There is also a risk of infection, fat necrosis, and the formation of cysts or lumps. In some cases, there may be asymmetry or irregularities in the contour of the treated area. These side effects are generally mild and resolve over time, but more severe complications, although rare, can occur.

What prior FDA approvals exist?

The FDA has approved several devices for autologous fat transfer, focusing on fat graft retention through lipoaspirate processing. Notably, the Revolve System (K120902) and the AuraGen 1-2-3 with AuraClens Lipoaspirate Wash System (BK190433) are two such devices. These systems are designed to process lipoaspirate to enhance fat graft retention, which is crucial for successful autologous fat grafting procedures, such as those used in breast reconstruction and cosmetic enhancements.

What other types of research exist?

Promising novel alternatives for autologous fat transfer in 2024 include the use of advanced techniques such as the Puregraft system, which offers a closed, sterile fat graft processing method to enhance fat retention. Additionally, the Lipogems system, which processes fat tissue into smaller clusters while preserving the stromal vascular fraction, is gaining attention for its regenerative properties and improved graft survival. Both systems are designed to optimize fat graft retention and patient outcomes.

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Lipoaspirate Processing Device

Fat Grafting Devices for Breast Enhancement

N/A

Waitlist Available

Led By Daniel A Del Vecchio, MD

Research Sponsored by AuraGen Aesthetics LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients between 18 and 65 years of age

Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) without a breast implant

Must not have

Skin rash in the treatment area

Patients with bleeding disorders or currently taking anticoagulants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post-op

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, potential side effects may include reactions at the treatment site such as swelling, bruising or infection; systemic responses like allergic reactions; and complications related to the procedure itself.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman aged between 18 and 65.

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

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I have suitable sites on my body for fat grafting.

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My surgery is expected to remove between 400 and 1400 cc of fat.

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I am expected to receive 150-350 cc of fat injection per breast.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a skin rash where I am receiving treatment.

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I have a bleeding disorder or am currently on blood thinners.

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I have had surgery or an injury in the area where I would receive treatment.

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I have a history of breast cancer.

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I have an ongoing or recurring infection.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post-op

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post-op

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post-op for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Fat volume retention at 12 months post-op

Fat volume retention at 3 months post-op

Fat volume retention at 6 months post-op

Secondary study objectives

Patient Satisfaction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Fat grafting with the AuraGen 1-2-3 with AuraClens SystemActive Control1 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 SystemActive Control1 Intervention

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

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Autologous fat transfer involves harvesting fat from one part of the body and transplanting it to another area to correct contour defects. The mechanisms of action include the careful processing of lipoaspirate to enhance fat cell viability and retention. Systems like the Revolve System and AuraGen 1-2-3 with AuraClens Lipoaspirate Wash System are designed to optimize this process by purifying and concentrating the fat cells, which can lead to better graft retention and more predictable outcomes. This is crucial for patients as it minimizes the need for repeat procedures, reduces complications, and improves the overall aesthetic results.