Clinical trial NCT05258305: AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
Official title: Prospective Study on Fat Retention When Using the AuraGen 1-2-3™ With AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Fat Grafting Retention
Lead sponsor: Tiger Biosciences, LLC.
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 200
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-randomized open-label study with a patient population consisting of up to 200 subjects divided in 2 cohorts with 100 patients each: reconstruction and augmentation.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fat Grafting Volume Retention
timeFrame: 1 Year
measure: Patient Satisfaction
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Tessler Plastic Surgery
state: Arizona
city: Beverly Hills
country: United States
facility: Aura Aesthetica, Inc.
state: California
city: Miami
country: United States
facility: Baptist Miami / Miami Cancer Institute
state: Florida
city: Carmel
country: United States
facility: Meridian Plastic Surgery
state: Indiana
city: Overland Park
country: United States
facility: Ascentist Plastic Surgery
state: Kansas
city: Louisville
country: United States
facility: Calo Aesthetics
state: Kentucky
city: Metairie
country: United States
facility: Dallas Plastic Surgery
state: Louisiana
city: West Long Branch
country: United States
facility: V Plastic Surgery
state: New Jersey
city: New York
country: United States
facility: NYU Langone Plastic Surgery Associates
state: New York
city: New York
country: United States
facility: Luxurgery
state: New York
city: Huntersville
country: United States
facility: Hunstad Kortesis Bharti Cosmetic Surgery
state: North Carolina
city: Austin
country: United States
facility: Restora Austin
state: Texas
city: Richardson
country: United States
facility: Regional Plastic Surgery
state: Texas
city: University Park
country: United States
facility: Dallas Plastic Surgery
state: Texas
city: Bellevue
country: United States
facility: Bellevue Plastic Surgery
state: Washington
Study officials:
affiliation: Tiger Biosciences, LLC.
name: Denise Dajles, PhD
role: STUDY_DIRECTOR
References: