Trial Outcomes & Findings for AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast (NCT NCT05258305)
NCT ID: NCT05258305
Last Updated: 2026-08-05
Results Overview
Fat grafting volume retention from procedure to 12-months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
1 Year
Results posted on
2026-08-05
Participant Flow
Participant milestones
| Measure |
Augmentation
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
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.
|
Reconstruction
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
105
|
|
Overall Study
COMPLETED
|
74
|
88
|
|
Overall Study
NOT COMPLETED
|
21
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AuraClens™ System in Processing of Lipoaspirate for Autologous Fat Grafting to the Breast
Baseline characteristics by cohort
| Measure |
Augmentation
n=85 Participants
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
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.
|
Reconstruction
n=105 Participants
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
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.
|
Total
n=190 Participants
Total of all reporting groups
|
|---|---|---|---|
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BMI
|
25.4 kg/m2
STANDARD_DEVIATION 3.7 • n=20 Participants
|
26.4 kg/m2
STANDARD_DEVIATION 4.7 • n=20 Participants
|
25.9 kg/m2
STANDARD_DEVIATION 4.3 • n=40 Participants
|
|
Age, Continuous
|
43.3 years
n=20 Participants
|
51.6 years
n=20 Participants
|
47.9 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=20 Participants
|
105 Participants
n=20 Participants
|
190 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
68 Participants
n=20 Participants
|
91 Participants
n=20 Participants
|
159 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
3 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 1 YearFat grafting volume retention from procedure to 12-months.
Outcome measures
| Measure |
Augmentation
n=137 breasts
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
|
Reconstruction
n=151 breasts
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
|
|---|---|---|
|
Fat Grafting Volume Retention
|
83 % retention
Interval 80.0 to 86.0
|
85 % retention
Interval 85.0 to 89.0
|
PRIMARY outcome
Timeframe: 1 YearConfidence/Satisfaction
Outcome measures
| Measure |
Augmentation
n=70 Participants
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
|
Reconstruction
n=84 Participants
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
|
|---|---|---|
|
Patient Satisfaction
|
61 Participants
|
68 Participants
|
Adverse Events
Augmentation
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Reconstruction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Augmentation
n=85 participants at risk
Subjects undergoing an aesthetic fat grafting procedure to the breast with or without a breast implant.
|
Reconstruction
n=105 participants at risk
Subjects undergoing reconstructive fat grafting procedure to the breast with or without a breast implant.
|
|---|---|---|
|
Infections and infestations
infection at access site
|
1.2%
1/85 • Number of events 1 • from enrollment until end of follow-up, up to 12 months.
|
0.00%
0/105 • from enrollment until end of follow-up, up to 12 months.
|
|
Vascular disorders
liposuction donor site hematoma
|
1.2%
1/85 • Number of events 1 • from enrollment until end of follow-up, up to 12 months.
|
0.00%
0/105 • from enrollment until end of follow-up, up to 12 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place