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Device

A123+AuraClens for Breast Fat Grafting Retention (AuraGen Trial)

N/A
Waitlist Available
Research Sponsored by Sientra, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Female patients > 22 years and < 65 years of age
Patients with available/adequate harvest sites for fat grafting.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

AuraGen Trial Summary

This trial is testing a new lipoaspirate wash system called the A123+AuraClens. 200 patients will receive autologous lipoaspirate processed with the A123+ AuraClens system during breast reconstruction or augmentation surgery. The fat graft retention and patient satisfaction will be measured at 1, 3, 6, and 12 months post-procedure.

Who is the study for?
This trial is for non-smoking women aged 22-65 with a BMI under 35, who are getting fat grafting to the breast, with or without implants. They must have an anticipated implant volume of 200-550 cc and harvested fat volume of 200-700 cc. Participants should not be pregnant, breastfeeding, or have bleeding disorders, active infections, compromised immune systems, untreated substance abuse issues, or hypersensitivity to pain medications.Check my eligibility
What is being tested?
The study is testing the AuraGen 1-2-3™ with AuraClens™ system's effectiveness in processing fat tissue before it's grafted into the breast. It aims to see how well this method helps retain the transferred fat over time in a non-randomized setting across multiple centers.See study design
What are the potential side effects?
While specific side effects aren't listed for this device-based procedure, common risks may include infection at the extraction or injection site, pain or discomfort from the procedure itself and possible allergic reactions to any materials used.

AuraGen Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman between 23 and 64 years old.
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I have suitable body areas for fat grafting.
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I am having a cosmetic fat transfer to my breast, with or without an implant.
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I have had radiotherapy to my breast.
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My surgery is expected to remove between 200 and 700 cc of fat.
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I am a woman aged between 18 and 65.
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I finished my chemotherapy over a year ago.
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I have suitable body areas for fat removal for grafting.
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I have a condition like diabetes that weakens my immune system.
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I have an ongoing or recurring infection.
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I have a bleeding disorder or am currently on blood thinners.
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I have a skin rash where I am receiving treatment.
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I am having a cosmetic fat transfer to my breast, with or without an implant.
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I am expected to receive a fat injection of 50-350 cc per breast.
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I am currently receiving treatment for breast cancer.

AuraGen Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year 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 Grafting Volume Retention
Patient Satisfaction

AuraGen Trial Design

2Treatment groups
Experimental Treatment
Group I: ReconstructionExperimental Treatment1 Intervention
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
Group II: AugmentationExperimental Treatment1 Intervention
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.

Find a Location

Who is running the clinical trial?

Sientra, Inc.Lead Sponsor
6 Previous Clinical Trials
7,445 Total Patients Enrolled
Denise Dajles, PhDStudy DirectorSientra, Inc.
1 Previous Clinical Trials
1,788 Total Patients Enrolled

Media Library

AuraCleans123+ (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05258305 — N/A
Breast Fat Grafting Retention Research Study Groups: Augmentation, Reconstruction
Breast Fat Grafting Retention Clinical Trial 2023: AuraCleans123+ Highlights & Side Effects. Trial Name: NCT05258305 — N/A
AuraCleans123+ (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05258305 — N/A
Breast Fat Grafting Retention Patient Testimony for trial: Trial Name: NCT05258305 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an opportunity for me to participate in this experiment?

"This clinical experiment requires 200 individuals of a qualifying age bracket (22-65) to partake. In order for enrolment, the following conditions must be met: Participants are obliged to maintain their figures by abstaining from making any drastic changes in diet or exercise; female patients with BMI lower than 30 and non-smokers only; participants need to sign an informed consent form showing that they understand all procedures related to this study as well as comply with follow up visits; harvesting site should have adequate fat volume between 200-700cc while injection volume must fall between 100-300cc per breast. Finally, implant size needs lie within the range of"

Answered by AI

Are there still available slots for individuals to join this experiment?

"According to the details provided on clinicaltrials.gov, this study is actively recruiting patients since its commencement on May 5th 2022 and latest amendment in early May of 2021."

Answered by AI

Does this project accept enrollment from seniors sixty years and older?

"According to the stipulated requirements of this investigation, potential participants must be between 22 and 65 years old."

Answered by AI

To what extent is this trial being utilized by participants?

"Affirmative. According to clinicaltrials.gov, the medical research project was initially publicized on May 5th 2022 and has most recently been modified as of June 9th 2022 is actively recruiting 200 individuals from 1 centre."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Arizona
California
What site did they apply to?
Dallas Plastic Surgery
Aura Aesthetica, Inc.
Other
Tessler Plastic Surgery
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To boost my confidence. I want to gain confidence with *******. I really want to have big breast and im willing to try anything.
PatientReceived no prior treatments
I would really like to help out in this trial thank u so much lupita. I have 2 silicon Implants that have imploded almost 2 years ago would like to something new.
PatientReceived 1 prior treatment

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Aura Aesthetica, Inc.: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
2022. "AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05258305.
~47 spots leftby Nov 2024
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