Feasibility Study of Meso BioMatrix Device for Breast Reconstruction

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

The purpose of the study is to evaluate the safety and feasibility of the use of Meso BioMatrix Acellular Peritoneum Matrix for the reinforcement of weakened soft tissue during 2-stage, tissue expander assisted breast reconstruction.

Key facts

Study ID: NCT01823107
Run by: Kensey Nash Corporation
People needed: 25
Starts: 2012-10-01
Expected to finish: 2017-06-29
Last updated by the study team: 2019-09-10

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Non-smoker
Undergoing unilateral or bilateral, two-stage, tissue expander-assisted breast reconstruction
Life expectancy greater than 18 months
Agreement to return for the trial required follow-up visits

You may not qualify if…

Body mass index ≥ 35
Prior reconstructive breast surgery, breast augmentation, mastopexy or reduction mammoplasty
History of chronic corticosteroid use
Type I Diabetes
History of radiation therapy to the chest
Pre-operative treatment with induction chemotherapy for breast cancer
Pregnancy
Participating in another investigational drug or device trial that has not completed the follow-up period

Where it is running

Henry Ford Health System — Detroit, Michigan, United States
Long Island Plasic Surgical Group, PC — Garden City, New York, United States
Long Island Plastic Surgical Group, PC — Garden City, New York, United States
Cancer Center of America at Eastern Regional Medical Center / Dr. Glat Plastic & Reconstructive Surgery — Bala-Cynwyd, Pennsylvania, United States
Vanderbilt University Medical Center — Nashville, Tennessee, United States
University of Utah (Huntsman Cancer Hospital) — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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