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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-19

Study Completion Date

2027-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mastectomy Mammaplasty Breast Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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REVOLVE Advanced Adipose System

Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.

Group Type ACTIVE_COMPARATOR

REVOLVE Advanced Adipose System

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

LipoGrafter

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Viality

Intervention Type PROCEDURE

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).

Intervention Type DEVICE

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).

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Suspected or known to be pregnant
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status RECRUITING

Countries

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United States

Central Contacts

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Makayla Kochheiser

Role: CONTACT

740.816.9707

Facility Contacts

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Yunchan Chen

Role: primary

858.997.6026

Other Identifiers

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20-10022850

Identifier Type: -

Identifier Source: org_study_id

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