A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
NCT ID: NCT04891510
Last Updated: 2025-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
135 participants
INTERVENTIONAL
2021-05-19
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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REVOLVE Advanced Adipose System
Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.
REVOLVE Advanced Adipose System
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).
LipoGrafter
Participants will receive the LipoGrafter technique during breast reconstruction.
LipoGrafter
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).
Viality
Participants will receive the Viality technique during breast reconstruction.
Viality
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.
Interventions
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REVOLVE Advanced Adipose System
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).
LipoGrafter
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).
Viality
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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David Otterburn, MD
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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New York Presbyterian - Weill Cornell Medicine
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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20-10022850
Identifier Type: -
Identifier Source: org_study_id
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