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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post-op
Awards & highlights

Study Summary

This trial compares how well two devices preserve fat during a liposuction procedure.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Patient Satisfaction

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.

Find a Location

Who is running the clinical trial?

AuraGen Aesthetics LLCLead Sponsor
Daniel A Del Vecchio, MDPrincipal InvestigatorBack Bay Plastic Surgery

Media Library

AuraGen 1-2-3 with AuraClens system (BK190433) (Lipoaspirate Processing Device) Clinical Trial Eligibility Overview. Trial Name: NCT04906811 — N/A
Autologous Fat Transfer Research Study Groups: Fat grafting with the AuraGen 1-2-3 with AuraClens System, Fat grafting with the Revolve System
Autologous Fat Transfer Clinical Trial 2023: AuraGen 1-2-3 with AuraClens system (BK190433) Highlights & Side Effects. Trial Name: NCT04906811 — N/A
AuraGen 1-2-3 with AuraClens system (BK190433) (Lipoaspirate Processing Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04906811 — N/A
~4 spots leftby May 2025
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