Can a new washing system make fat grafts last longer?
NCT ID NCT05258305
First seen Aug 05, 2026 · Last updated Aug 06, 2026 · Updated 1 time
Summary
This trial is testing whether a device called AuraGen 1-2-3 with AuraClens can improve how much fat stays in place after breast fat grafting. The study will enroll 200 women undergoing breast augmentation with or without implants. Researchers will measure fat retention over 12 months and track patient satisfaction. The goal is to see if this washing and filtering system leads to better, longer-lasting results.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AuraGen 1-2-3 with AuraClens system (a device for washing and filtering lipoaspirate before fat grafting)
- What this could lead to
- If successful, this could improve the longevity of fat grafts in breast augmentation, leading to better cosmetic outcomes and higher patient satisfaction.
- What could go wrong
- This is a post-market study, not a randomized controlled trial, so results may be less definitive. Fat retention can vary widely between individuals, and the device's benefit over standard processing is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
200 people
The number who actually took part.
- Started
-
May 2022
- Finished
-
Jan 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
22 to 65 years
- Sex
-
Female participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Augmentation Subjects Inclusion Criteria: * Female patients \> 22 years and \< 65 years of age. * Patients with a BMI \< 35. * Patients undergoing an aesthetic fat grafting procedure to the breast (breast augmentation) with or without a breast implant. * Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits. * Patients must be non-smokers. * Patients with available/adequate harvest sites for fat grafting. * Anticipated harvested fat volume between 200 and 700 cc. * Anticipated fat injection volume between 50 and 350 cc per breast. * Anticipated breast implant volume between 200 and 550 cc. * Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study. Exclusion Criteria: * Skin rash in the treatment area. * Patients who smoke or use nicotine products. * Patients with bleeding disorders or currently taking anticoagulants. * Patients with history of trauma or surgery to the treatment area. * Patients with history of breast cancer. * Active, chronic, or recurrent infection. * Compromised immune system. * Hypersensitivity to analgesic agents. * Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements. * Untreated drug and/or alcohol abuse. * Pregnant or breastfeeding. * Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation. * Patients who do not wish to have the study area (breast) photographed. Reconstruction Subjects Inclusion Criteria: * Female patients \> 18 years and \< 65 years of age. * Patients with a BMI \< 35. * Patients undergoing a fat grafting procedure to the breast in a second or third stage of a staged breast reconstruction, with or without a breast implant. * Patient is at least 1 year post-completion of chemotherapy. * Patients must be able to provide written informed consent, understand and be willing to comply with study-related procedures and follow-up visits. * Patients must be non-smokers. * Patients with available/adequate harvest sites for fat grafting. * Anticipated harvested fat volume between 200 and 700 cc. * Anticipated fat injection volume between 50 nd 350cc per breast. * Anticipated breast implant volume (if applicable) between 200 and 550 cc. * Patients must agree to maintain their weight (i.e., within 5%) by not making any major changes in diet or lifestyle during the study. Exclusion Criteria: * Skin rash in the treatment area. * Patients who smoke or use nicotine products. * Patients with bleeding disorders or currently taking anticoagulants. * Patients undergoing active treatment for breast cancer. * Active, chronic, or recurrent infection. * Compromised immune system. * Hypersensitivity to analgesic agents. * Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements. * Untreated drug and/or alcohol abuse. * Pregnant or breastfeeding. * Any issue that, at the discretion of the Investigator, would contra-indicate the patient's participation. * Patients who do not wish to have the study area (breast) photographed.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast fat grafting retention are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Ascentist Plastic Surgery
Overland Park, Kansas, 66223, United States
-
Aura Aesthetica, Inc.
Beverly Hills, California, 90210, United States
-
Baptist Miami / Miami Cancer Institute
Miami, Florida, 33176, United States
-
Bellevue Plastic Surgery
Bellevue, Washington, 98004, United States
-
Calo Aesthetics
Louisville, Kentucky, 40222, United States
-
Dallas Plastic Surgery
Metairie, Louisiana, 70002, United States
-
Hunstad Kortesis Bharti Cosmetic Surgery
Huntersville, North Carolina, 28078, United States
-
Luxurgery
New York, New York, 10021, United States
-
Meridian Plastic Surgery
Carmel, Indiana, 46290, United States
-
NYU Langone Plastic Surgery Associates
New York, New York, 10017, United States
-
Regional Plastic Surgery
Richardson, Texas, 75082, United States
-
Restora Austin
Austin, Texas, 78705, United States
-
Tessler Plastic Surgery
Scottsdale, Arizona, 85251, United States
-
V Plastic Surgery
West Long Branch, New Jersey, 07784, United States