A Comparative Analysis of REVOLVE, LipoGrafter, and Viality in Autologous Fat Grafting During Breast Surgery

Weill Cornell Medicine (WCM)

Status: Enrolling

Conditions: Breast Reconstruction; Mastectomy; Mammaplasty

Treatments: Device: LipoGrafter; Device: REVOLVE Advanced Adipose System; Procedure: Viality

Study type: Interventional

Funder types: Other

Identifiers

NCT04891510

20-10022850

Details and patient eligibility

About

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.

Enrollment: 135 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 3 patient groups

REVOLVE Advanced Adipose System

Active Comparator group

Description:

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

Treatment:

Device: REVOLVE Advanced Adipose System

LipoGrafter

Active Comparator group

Description:

Participants will receive the LipoGrafter technique during breast reconstruction.

Treatment:

Device: LipoGrafter

Viality

Active Comparator group

Description:

Participants will receive the Viality technique during breast reconstruction.

Treatment:

Procedure: Viality