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

NCT05258305 | Unknown FDA Device

• 1 other identifier: AUG-002
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 15

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.

Conditions

Breast Fat Grafting Retention

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Augmentation

OTHER

Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.

Device: AuraGen 1-2-3 with AuraClens

Reconstruction

OTHER

Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.

Device: AuraGen 1-2-3 with AuraClens

Interventions

AuraGen 1-2-3 with AuraClens DEVICE

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.

Augmentation; Reconstruction

Eligibility Criteria

• Age: 22 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Female patients \> 18 years and \< 65 years of age.

Sponsors & Collaborators

• Tiger Biosciences, LLC.: lead

Study Sites (15)

Tessler Plastic Surgery

Scottsdale, Arizona, 85251, United States

Location

Aura Aesthetica, Inc.

Beverly Hills, California, 90210, United States

Location

Baptist Miami / Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Meridian Plastic Surgery

Carmel, Indiana, 46290, United States

Location

Ascentist Plastic Surgery

Overland Park, Kansas, 66223, United States

Location

Calo Aesthetics

Louisville, Kentucky, 40222, United States

Location

Dallas Plastic Surgery

Metairie, Louisiana, 70002, United States

Location

V Plastic Surgery

West Long Branch, New Jersey, 07784, United States

Location

NYU Langone Plastic Surgery Associates

New York, New York, 10017, United States

Location

Luxurgery

New York, New York, 10021, United States

Location

Hunstad Kortesis Bharti Cosmetic Surgery

Huntersville, North Carolina, 28078, United States

Location

Restora Austin

Austin, Texas, 78705, United States

Location

Regional Plastic Surgery

Richardson, Texas, 75082, United States

Location

Dallas Plastic Surgery

University Park, Texas, 75205, United States

Location

Bellevue Plastic Surgery

Bellevue, Washington, 98004, United States

Location

Study Officials

• Denise Dajles, PhD

  Tiger Biosciences, LLC.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: February 28, 2022
• Study Start: May 5, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)