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A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
Led by Weill Medical College of Cornell University · Updated on 2025-07-31
135
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying different fat processing methods to find out which one provides better graft retention during breast reconstruction after mastectomy. This study compares three techniques: REVOLVE Advanced Adipose System, LipoGrafter, and Viality, to see which is superior in maintaining fat graft volume and improving patient satisfaction. Participants will be randomly assigned to receive one of three fat grafting methods during their breast reconstruction surgery. The REVOLVE system processes fat by harvesting, filtering, washing, and removing strands for reinjection without additional steps. The LipoGrafter uses a closed system with minimal processing to reduce contamination and fat cell damage. The Viality technique employs a solution to wash away impurities like blood and oil before suctioning. Participants will have baseline and 90-day follow-up assessments including 3D volumetric scans to measure fat graft retention and complete the BREAST-Q questionnaire to evaluate satisfaction. Physical exams at 90 days will check for lumps, fat necrosis lesions, infections, seroma, and wound healing. The study will monitor these outcomes to compare the effectiveness and safety of the fat grafting methods over the short term.
CONDITIONS
Brief Title
A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- Documented history of previous breast surgery (either complete or partial mastectomy)
- Available harvest sites for fat grafting as documented by plastic surgeon
- Body mass index (BMI) greater than 20
- Anticipated harvested fat volume greater than 50cc
- Competency and willingness to provide consent
You will not qualify if you...
- Suspected or known to be pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo breast reconstruction surgery using one of three fat grafting techniques: REVOLVE Advanced Adipose System, LipoGrafter, or Viality.
1 surgical visit (in-person)
Duration - 90 days
Participants are monitored for outcomes including fat grafting efficacy, patient satisfaction, and physical exam assessments of masses, lesions, infection, seroma, and wound healing.
1 follow-up visit at 90 days (in-person)
Trial Site Locations
Total: 1 location
1
New York Presbyterian - Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
Research Team
M
Makayla Kochheiser
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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