Breast Fat Grafting RetentionAuraGenNCT05258305

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

A study testing AuraGen 1-2-3 with AuraClens in people with Breast Fat Grafting Retention, run by Tiger Biosciences, LLC. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Fat Grafting Retention
What is being tested?: AuraGen 1-2-3 with AuraClens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 14 sitesUnited States
Study dates: 5 May 2022to 8 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.
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.

Who cannot join

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.

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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
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.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

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

Other trials in United States

About this study

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

Read the 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.

Conditions: Breast Fat Grafting Retention
Being tested: AuraGen 1-2-3 with AuraClens

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AuraGen 1-2-3 with AuraClensDevice
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.

Study groups in NCT05258305
Study group	Role	What they receive
Augmentation	Other	Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant. Receives: Device: AuraGen 1-2-3 with AuraClens
Reconstruction	Other	Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant. Receives: Device: AuraGen 1-2-3 with AuraClens

What is being measured

The primary outcome is the main question the study is designed to answer.

Fat Grafting Volume Retention
Fat grafting volume retention from procedure to 12-months.
Measured: 1 Year
Patient Satisfaction
Confidence/Satisfaction
Measured: 1 Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 May 20228 Jan 2025

First posted28 Feb 2022
Study start5 May 2022
Primary completion8 Jan 2025
Study completion8 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast Fat Grafting RetentionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
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)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05258305
Sponsor's protocol ID: AUG-002
Acronym: AuraGen
Status last verified: Jul 2026
First submitted: 17 Feb 2022
Last updated: 5 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Shridharani SM, Eagan S, Tessler O, Medina MA 3rd, Saul SM, Calobrace MB. A Multicenter Prospective Study of Enhanced Viability Fat Transfer for Cosmetic Augmentation and Reconstruction of the Breast. Plast Reconstr Surg. 2026 May 19. doi: 10.1097/PRS.0000000000013190. Online ahead of print.
PubMed 42153746

Study at a glance

From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05258305
Acronym / sponsor ID: AuraGen / AUG-002
Conditions: Breast Fat Grafting Retention
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Tiger Biosciences, LLC.Industry (pharma, biotech, devices)
Study start: 5 May 2022 (actual)
Primary completion: 8 Jan 2025 (actual)
Study completion: 8 Jan 2025 (actual)
First posted: 28 Feb 2022 (actual)
Results: Posted 5 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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.

Arm	Type	Receives
Augmentation	Other	Device: AuraGen 1-2-3 with AuraClensSubjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
Reconstruction	Other	Device: AuraGen 1-2-3 with AuraClensSubjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.

Who may qualify

Ages: 22 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

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.

Key exclusion criteria (26 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AuraGen 1-2-3 with AuraClensAutologous 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.	Device	Augmentation, Reconstruction

Primary outcome

Fat Grafting Volume Retention
Time frame: 1 Year
Fat grafting volume retention from procedure to 12-months.
Patient Satisfaction
Time frame: 1 Year
Confidence/Satisfaction

Results and safety

Results posted to the registry on 5 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Augmentation	95	74
Reconstruction	105	88

Primary outcome: Fat Grafting Volume Retention

Time frame: 1 Year. Mean (95% Confidence Interval). Unit: % retention

Measure	Augmentation n = 70	Reconstruction n = 84
Value	83 (80 to 86)	85 (85 to 89)

Primary outcome: Patient Satisfaction

Time frame: 1 Year. Count of participants. Unit: Participants

Measure	Augmentation n = 70	Reconstruction n = 84
Value	61	68

Adverse events

Time frame: from enrollment until end of follow-up, up to 12 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Augmentation	0 of 85 (0%)	2 of 85 (2.4%)	0 of 85
Reconstruction	0 of 105 (0%)	0 of 105 (0%)	0 of 105

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 42153746Shridharani SM, Eagan S, Tessler O, Medina MA 3rd, Saul SM, Calobrace MB. A Multicenter Prospective Study of Enhanced Viability Fat Transfer for Cosmetic Augmentation and Reconstruction of the Breast. Plast Reconstr Surg. 2026 May 19. doi: 10.1097/PRS.0000000000013190. Online ahead of print.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sara Saul, PhD study director

Tiger Biosciences, LLC.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AuraGen 1-2-3 with AuraClens in people with Breast Fat Grafting Retention, run by Tiger Biosciences, LLC. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat Grafting Volume Retention (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05258305, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.