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

Study Overview
=================
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.

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

Conditions
-----------------
Breast Fat Grafting Retention

Intervention / Treatment
-----------------
* Device: AuraGen 1-2-3 with AuraClens


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Augmentation<br>Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant. | Device: AuraGen 1-2-3 with AuraClens<br>* 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.<br>|
| Other: Reconstruction<br>Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant. | Device: AuraGen 1-2-3 with AuraClens<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat Grafting Volume Retention | Fat grafting volume retention change from baseline to 12-months. | 1 Year | 
| Patient Satisfaction | 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). | 1 Year |