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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

Trial Design

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

Find a Location

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
1,054 Previous Clinical Trials
1,316,264 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: REVOLVE Advanced Adipose System, LipoGrafter, Standard Decantation
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the stated aims of this experiment?

"This clinical trial's primary outcome of interest, which will be assessed at Baseline and 90 day follow-up, is to determine the efficacy alteration in fat grafting technique via 3D volumetric scanning. Secondary objectives include enumerating probable fat necrosis lesions from the treatment by physical exam, ascertaining seroma presence with a "yes/no" binary item on physical examination, as well as measuring wound healing through a similar binary evaluation."

Answered by AI

What is the scope of participants for this clinical experiment?

"Indeed, the current records on clinicaltrials.gov stipulate that this research project is enrolling patients at present. This study was first published on May 19th 2021 and most recently updated July 28th 2022 with a call for 45 participants from just one site."

Answered by AI

Is enrollment currently possible for this experiment?

"As per data hosted on clinicaltrials.gov, this research trial is actively recruiting participants; it was first advertised on May 19th 2021 and its most recent update occurred on July 28th 2022."

Answered by AI

Who else is applying?

What site did they apply to?
New York Presbyterian - Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

I had fat transfer to ******* 2.5 years ago but most of it has disappeared. Hoping a different method will create longer lasting results.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Comparative Analysis of REVOLVE, LipoGrafter, and the Standard Decantation Technique in Autologous Fat Grafting During Breast Surgery
2021. "A Comparative Analysis of REVOLVE, LipoGrafter, and the Standard Decantation Technique in Autologous Fat Grafting During Breast Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04891510.
~11 spots leftby May 2025
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