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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post-op
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a condition like diabetes that weakens my immune system.I am having a breast fat grafting procedure without an implant.I have an ongoing or recurring infection.I am a woman aged between 18 and 65.I have a skin rash where I am receiving treatment.I have a bleeding disorder or am currently on blood thinners.I have had surgery or an injury in the area where I would receive treatment.I have a history of breast cancer.I do not want my breast area to be photographed for the study.I have suitable sites on my body for fat grafting.My surgery is expected to remove between 400 and 1400 cc of fat.I am expected to receive 150-350 cc of fat injection per breast.
Research Study Groups:
This trial has the following groups:- Group 1: Fat grafting with the AuraGen 1-2-3 with AuraClens System
- Group 2: Fat grafting with the Revolve System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I a viable candidate to enroll in this medical research?
"This research requires 20 willing volunteers, aged 18-65 with autologous fat grafting. Additional criteria include a non-smoking status and female gender; participants must also be undergoing cosmetic augmentation of the breast without an implant, and anticipate a harvestable volume between 400-1400 cc."
Answered by AI
Are there still openings for volunteers in this experiment?
"Affirmative. Clinical trials available on clinicaltrials.gov indicate that the study, which was first opened to enrolment on May 20th 2021, is still open and actively seeking participants. Twenty patients are needed across one medical centre for this trial to proceed."
Answered by AI
How many participants are being recruited for this trial?
"Affirmative. The clinicaltrials.gov portal reveals that this experimental procedure, which was launched on the 20th of May 2021, is actively seeking enrollees. Thus far, only 1 medical site has been identified to take part in the trial and it needs a total of twenty patients for their research efforts."
Answered by AI
Are there age limitations with regards to eligibility for this experiment?
"In accordance with the outlined parameters, participants must be of legal age or older and below 65 years old."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
Back Bay Plastic Surgery
Why did patients apply to this trial?
Loss of breast fullness in relation to normal aging. I am looking for a solution for super flat chest I have all my life it’s been really small.
PatientReceived 1 prior treatment
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