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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Fat Grafting Retention
• Intervention / Treatment: Device: AuraGen 1-2-3 with AuraClens

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Genice Gallegos; Phone Number: (805) 895-1843; Email: genice.gallegos@veranex.com

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Tessler Plastic Surgery
  • California
    • Beverly Hills, California, United States, 90210
      • Aura Aesthetica, Inc.
  • Florida
    • Miami, Florida, United States, 33176
      • Baptist Miami / Miami Cancer Institute
  • Indiana
    • Carmel, Indiana, United States, 46290
      • Meridian Plastic Surgery
  • Kansas
    • Overland Park, Kansas, United States, 66223
      • Ascentist Plastic Surgery
  • Kentucky
    • Louisville, Kentucky, United States, 40222
      • Calo Aesthetics
  • Louisiana
    • Metairie, Louisiana, United States, 70002
      • Dallas Plastic Surgery
  • New Jersey
    • West Long Branch, New Jersey, United States, 07784
      • V Plastic Surgery
  • New York
    • New York, New York, United States, 10021
      • Luxurgery
    • New York, New York, United States, 10017
      • NYU Langone Plastic Surgery Associates
  • North Carolina
    • Huntersville, North Carolina, United States, 28078
      • Hunstad Kortesis Bharti Cosmetic Surgery
  • Texas
    • Austin, Texas, United States, 78705
      • Restora Austin
    • Richardson, Texas, United States, 75082
      • Regional Plastic Surgery
    • University Park, Texas, United States, 75205
      • Dallas Plastic Surgery
  • Washington
    • Bellevue, Washington, United States, 98004
      • Bellevue Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Augmentation; Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.	Device: 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.
Other: Reconstruction; Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.	Device: 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.

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

Collaborators and Investigators

• Sponsor: Sientra, Inc.
• Investigators: Study Director: Denise Dajles, PhD, Sientra, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2022
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 17, 2022
• First Submitted That Met QC Criteria: February 25, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Estimated): December 4, 2023
• Last Update Submitted That Met QC Criteria: November 30, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AUG-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes