MastectomyNCT04891510
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
A study testing REVOLVE Advanced Adipose System, LipoGrafter and Viality in people with Mastectomy and Mammaplasty, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Mastectomy, Mammaplasty, Breast Reconstruction
- What is being tested?
- REVOLVE Advanced Adipose System, LipoGrafter and Viality
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 19 May 2021to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female;
- Documented history of previous breast surgery (either complete or partial mastectomy);
- Available harvest sites for fat grafting as documented by plastic surgeon;
- BMI > 20;
- Anticipated harvested fat volume > 50cc;
- Competency and willingness to provide consent
Who cannot join
- Suspected or known to be pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
New York Presbyterian - Weill Cornell Medicine
New York, New York, 10021
Michael B Amrami, MPH, 646-544-7658, mia7046@med.cornell.edu
Daana Bajnauth, 646-789-1447, dab4001@med.cornell.edu
About this study
The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.
- Conditions
- Mastectomy, Mammaplasty, Breast Reconstruction
- Being tested
- REVOLVE Advanced Adipose System, LipoGrafter, Viality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REVOLVE Advanced Adipose SystemDevice
The REVOLVE system is an all-in-one fat processing device that harvests, filters, actively washes, and removes strands from lipoaspirate and allows for reinjection without any additional manipulation (REVOLVE 2020).
LipoGrafterDevice
The LipoGrafter system is designed to be a start-to-finish closed system with minimal processing of the lipoaspirate, minimizing the risk of contamination and fat cell damage (LipoGrafter 2020).
VialityProcedure or surgery
The Viality system uses the AuraClens solution that acts as a surfactant to bring impurities like blood, free oil, and cellular debris into solution, where they can be flushed out through suction.
| Study group | Role | What they receive |
|---|---|---|
| REVOLVE Advanced Adipose System | Active comparator | Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction. Receives: Device: REVOLVE Advanced Adipose System |
| LipoGrafter | Active comparator | Participants will receive the LipoGrafter technique during breast reconstruction. Receives: Device: LipoGrafter |
| Viality | Active comparator | Participants will receive the Viality technique during breast reconstruction. Receives: Procedure: Viality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site
3D volumetric scanning assesses the fat graft retention defined as the ratio of fat remaining at the surgical site at 90 day follow-up to that at pre-operative baseline.
Measured: Baseline, 90 day follow-up
Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire
The BREAST-Q questionnaire is used for measuring pre- and postoperative psychosocial, physical, and sexual well-being, satisfaction with breasts, experience of care, and satisfaction with outcome. Scores range on a 0-100 scale, with higher scores indicating better outcomes.
Measured: Baseline, 90 day follow-up
Secondary outcomes (5)
Number of palpable masses from the fat grafting technique, as measured by a physical exam.
The physical exam will provide the number of palpable masses at the surgical site.
Measured: 90 day follow-up
Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam
The physical exam will provide the number of lesions of probable fat necrosis at the surgical site
Measured: 90 day follow-up
Presence of infection from the fat grafting technique, as measured by a physical exam
The physical exam will show if there is infection present at the surgical site. This is a binary "yes/no" item.
Measured: 90 day follow-up
Presence seroma from the fat grafting technique, as measured by a physical exam
The physical exam will show if there is seroma present at the surgical site. This is a binary "yes/no" item.
Measured: 90 day follow-up
Assessment of wound healing from the fat grafting technique, as measured by a physical exam
The physical exam will show if wound healing is normal or delayed at the surgical site. This is a binary "normal/delayed" item.
Measured: 90 day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start19 May 2021
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MastectomyStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Otterburn, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891510
- Sponsor's protocol ID
- 20-10022850
- Status last verified
- Jun 2026
- First submitted
- 17 May 2021
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
- ClinicalTrials.gov ID
- NCT04891510
- Acronym / sponsor ID
- 20-10022850
- Conditions
- Mastectomy, Mammaplasty, Breast Reconstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 19 May 2021 (actual)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to learn whether there is a superior fat processing method in terms of graft retention in breast reconstruction after mastectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| REVOLVE Advanced Adipose System | Active comparator | Device: REVOLVE Advanced Adipose SystemParticipants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction. |
| LipoGrafter | Active comparator | Device: LipoGrafterParticipants will receive the LipoGrafter technique during breast reconstruction. |
| Viality | Active comparator | Procedure: VialityParticipants will receive the Viality technique during breast reconstruction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female;
- Documented history of previous breast surgery (either complete or partial mastectomy);
- Available harvest sites for fat grafting as documented by plastic surgeon;
- BMI > 20;
- Anticipated harvested fat volume > 50cc;
Key exclusion criteria (1 listed)
- Suspected or known to be pregnant
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 |
|---|---|---|
| REVOLVE Advanced Adipose SystemThe REVOLVE system is an all-in-one fat processing device that harvests, filters, actively washes, and removes strands from lipoaspirate and allows for reinjection without any additional manipulation (REVOLVE 2020). | Device | REVOLVE Advanced Adipose System |
| LipoGrafterThe LipoGrafter system is designed to be a start-to-finish closed system with minimal processing of the lipoaspirate, minimizing the risk of contamination and fat cell damage (LipoGrafter 2020). | Device | LipoGrafter |
| VialityThe Viality system uses the AuraClens solution that acts as a surfactant to bring impurities like blood, free oil, and cellular debris into solution, where they can be flushed out through suction. | Procedure or surgery | Viality |
Primary outcome
Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site
Time frame: Baseline, 90 day follow-up
3D volumetric scanning assesses the fat graft retention defined as the ratio of fat remaining at the surgical site at 90 day follow-up to that at pre-operative baseline.
Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire
Time frame: Baseline, 90 day follow-up
The BREAST-Q questionnaire is used for measuring pre- and postoperative psychosocial, physical, and sexual well-being, satisfaction with breasts, experience of care, and satisfaction with outcome. Scores range on a 0-100 scale, with higher scores indicating better outcomes.
5 secondary outcomes
Number of palpable masses from the fat grafting technique, as measured by a physical exam.
Time frame: 90 day follow-up
Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam
Time frame: 90 day follow-up
Presence of infection from the fat grafting technique, as measured by a physical exam
Time frame: 90 day follow-up
Presence seroma from the fat grafting technique, as measured by a physical exam
Time frame: 90 day follow-up
Assessment of wound healing from the fat grafting technique, as measured by a physical exam
Time frame: 90 day follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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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.
David Otterburn, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REVOLVE Advanced Adipose System, LipoGrafter and Viality in people with Mastectomy and Mammaplasty, run by Weill Medical College of Cornell University at 1 site 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 6 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Amrami, MPH (646-544-7658, mia7046@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site (time frame: Baseline, 90 day follow-up). 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?
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 22 Jun 2026.