AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
- Conditions
- Breast Fat Grafting Retention
- Registration Number
- NCT05258305
- Lead Sponsor
- Sientra, Inc.
- Brief Summary
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.
- Detailed Description
Autologous fat transfer (AFT) is a medical procedure that includes aspirating adipose tissue from one part of the body, and washing, filtering and re-injecting the processed fat tissue into a different part of the body with the primary purpose of adding volume. The AuraGen1-2-3 with AuraClens Lipoaspirate Wash System is designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister. The study population will consist of up to 200 subjects in (2) cohorts: 100 subjects undergoing breast reconstruction and 100 subjects undergoing breast augmentation. All subjects will receive autologous lipoaspirate processed with the A123+ AuraClens and will be followed post-procedure at 1-, 3-, 6-, and 12-months. Fat graft retention will be evaluated with 3D imaging using the Canfield Vectra XT imaging system. Patient satisfaction will be measured between baseline and the post-procedure follow-up visits using a breast satisfaction questionnaire.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Fat Grafting Volume Retention 1 Year Fat grafting volume retention change from baseline to 12-months.
Patient Satisfaction 1 Year Sientra Breast Satisfaction Questionnaire survey results at 1, 3, 6 and 12-months post-operatively compared to baseline, based on a rating scale between 1 ("Strongly Disagree") to 7 ("Strongly Agree").
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
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
🇺🇸University Park, Texas, 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
Scroll for more (4 remaining)Tessler Plastic Surgery🇺🇸Scottsdale, Arizona, United States