Recruiting
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
What is being tested
REVOLVE Advanced Adipose System
+ LipoGrafter
+ Viality
DeviceProcedure
Who is being recruted
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: May 2021
Summary
Principal SponsorWeill Medical College of Cornell University
Study ContactMakayla Kochheiser
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: May 19, 2021
Actual date on which the first participant was enrolled.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.
Official TitleA Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
Principal SponsorWeill Medical College of Cornell University
Study ContactMakayla Kochheiser
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
135 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
6 inclusion criteria required to participate
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;
Show More Criteria
1 exclusion criteria prevent from participating
Suspected or known to be pregnant
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
3 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorParticipants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.
Group II
Active ComparatorParticipants will receive the LipoGrafter technique during breast reconstruction.
Group III
Active ComparatorParticipants will receive the Viality technique during breast reconstruction.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
New York Presbyterian - Weill Cornell Medicine
New York, United StatesOpen New York Presbyterian - Weill Cornell Medicine in Google MapsRecruiting
One Study Center