Status:
UNKNOWN
AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
Lead Sponsor:
Tiger Biosciences, LLC.
Conditions:
Breast Fat Grafting Retention
Eligibility:
FEMALE
22-65 years
Phase:
NA
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™ Lipo...
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 differen...
Eligibility Criteria
Inclusion
- Augmentation Subjects
- 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
- 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.
Key Trial Info
Start Date :
May 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05258305
Start Date
May 5 2022
End Date
November 30 2024
Last Update
December 4 2023
Active Locations (15)
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1
Tessler Plastic Surgery
Scottsdale, Arizona, United States, 85251
2
Aura Aesthetica, Inc.
Beverly Hills, California, United States, 90210
3
Baptist Miami / Miami Cancer Institute
Miami, Florida, United States, 33176
4
Meridian Plastic Surgery
Carmel, Indiana, United States, 46290