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

July 10, 2026 updated by: Tiger Biosciences, LLC.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
    • Washington
      • Bellevue, Washington, United States, 98004
        • Bellevue Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fat Grafting Volume Retention
Time Frame: 1 Year
Fat grafting volume retention from procedure to 12-months.
1 Year
Patient Satisfaction
Time Frame: 1 Year
Confidence/Satisfaction
1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tiger Biosciences, LLC.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Sara Saul, PhD, Tiger Biosciences, LLC.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 8, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 8, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 17, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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