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N/A

Autologous Fat Grafting Techniques for Breast Surgery

N/A
Recruiting
Led By David Otterburn, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Anticipated harvested fat volume > 50cc
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 day follow-up
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two methods of fat processing in terms of how well the fat survives after being transplanted into the breast.

Who is the study for?
This trial is for women who have had breast surgery, like a mastectomy, and need reconstruction. They should be able to provide consent, have enough fat in certain areas for grafting (over 50cc), and a BMI over 20. Pregnant individuals cannot participate.
What is being tested?
The study is comparing three methods of processing fat during breast reconstruction: LipoGrafter, REVOLVE Advanced Adipose System, and the Standard Decantation technique to see which one keeps the most fat after grafting.
What are the potential side effects?
Potential side effects may include pain at the site where fat is taken from or added to, swelling, bruising, infection risk at surgical sites, and possible dissatisfaction with cosmetic outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I expect to have more than 50cc of fat removed.
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I am female.
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I have had breast surgery before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 day follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 day follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in efficacy of fat grafting technique, as measured by 3D volumetric scanning at the surgical site
Change in patient satisfaction of fat grafting technique, as measured by the BREAST-Q questionnaire
Secondary study objectives
Assessment of wound healing from the fat grafting technique, as measured by a physical exam
Number of lesions of probable fat necrosis from the fat grafting technique, as measured by a physical exam
Number of palpable masses from the fat grafting technique, as measured by a physical exam.
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: VialityActive Control1 Intervention
Participants will receive the Viality technique during breast reconstruction.
Group II: REVOLVE Advanced Adipose SystemActive Control1 Intervention
Participants will receive the REVOLVE Advanced Adipose System technique during breast reconstruction.
Group III: LipoGrafterActive Control1 Intervention
Participants will receive the LipoGrafter technique during breast reconstruction.

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,655 Total Patients Enrolled
David Otterburn, MDPrincipal InvestigatorWeill Medical College of Cornell University

Media Library

LipoGrafter (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT04891510 — N/A
Mastectomy Research Study Groups: Viality, REVOLVE Advanced Adipose System, LipoGrafter
Mastectomy Clinical Trial 2023: LipoGrafter Highlights & Side Effects. Trial Name: NCT04891510 — N/A
LipoGrafter (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04891510 — N/A
~8 spots leftby May 2025
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