Can a new washing system make fat grafts last longer?

NCT ID NCT05258305

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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