AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
NCT ID: NCT05258305
Last Updated: 2023-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
200 participants
INTERVENTIONAL
2022-05-05
2024-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Augmentation
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
AuraGen 1-2-3 with AuraClens
Autologous fat transfer (AFT) is a minimally invasive 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 AuraGen 1-2-3 with AuraClens is a lipoaspirate wash system designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister.
Reconstruction
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
AuraGen 1-2-3 with AuraClens
Autologous fat transfer (AFT) is a minimally invasive 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 AuraGen 1-2-3 with AuraClens is a lipoaspirate wash system designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister.
Interventions
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AuraGen 1-2-3 with AuraClens
Autologous fat transfer (AFT) is a minimally invasive 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 AuraGen 1-2-3 with AuraClens is a lipoaspirate wash system designed to be used in the operating room in conjunction with a user-provided liposuction cannular, a vacuum source, and waste canister.
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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
* 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
* 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.
22 Years
65 Years
FEMALE
Yes
Sponsors
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Tiger Biosciences, LLC.
INDUSTRY
Responsible Party
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Principal Investigators
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Denise Dajles, PhD
Role: STUDY_DIRECTOR
Tiger Biosciences, LLC.
Locations
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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
Dallas Plastic Surgery
University Park, Texas, United States
Bellevue Plastic Surgery
Bellevue, Washington, United States
Countries
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Other Identifiers
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AUG-002
Identifier Type: -
Identifier Source: org_study_id