AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast

Completed · Not applicable

Conditions studied: Breast Fat Grafting Retention

In brief

Prospective, multi-center, non-randomized, open-label, post-market clinical study evaluating adipose graft retention over time from lipoaspirate processed using the AuraGen 1-2-3™ with AuraClens™ Lipoaspirate Wash System.

Key facts

Study ID: NCT05258305
Run by: Tiger Biosciences, LLC.
People needed: 200
Starts: 2022-05-05
Expected to finish: 2025-01-08
Last updated by the study team: 2026-08-05

Who can join

Age: 22 and older, up to 65. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Tessler Plastic Surgery — Scottsdale, Arizona, United States
Aura Aesthetica, Inc. — Beverly Hills, California, United States
Baptist Miami / Miami Cancer Institute — Miami, Florida, United States
Meridian Plastic Surgery — Carmel, Indiana, United States
Ascentist Plastic Surgery — Overland Park, Kansas, United States
Calo Aesthetics — Louisville, Kentucky, United States
Dallas Plastic Surgery — Metairie, Louisiana, United States
V Plastic Surgery — West Long Branch, New Jersey, United States
NYU Langone Plastic Surgery Associates — New York, New York, United States
Luxurgery — New York, New York, United States
Hunstad Kortesis Bharti Cosmetic Surgery — Huntersville, North Carolina, United States
Restora Austin — Austin, Texas, United States
Regional Plastic Surgery — Richardson, Texas, United States
Bellevue Plastic Surgery — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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