Status:
COMPLETED
Feasibility Study of Meso BioMatrix Device for Breast Reconstruction
Lead Sponsor:
Kensey Nash Corporation
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
NA
Brief Summary
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 expande...
Detailed Description
Following mastectomy, women may elect to have breast reconstruction with autologous tissue or breast implants. Two-stage, tissue expander assisted breast reconstruction is one of the common surgical m...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01823107
Start Date
October 1 2012
End Date
June 29 2017
Last Update
September 10 2019
Active Locations (6)
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1
Henry Ford Health System
Detroit, Michigan, United States, 48202
2
Long Island Plasic Surgical Group, PC
Garden City, New York, United States, 11530
3
Long Island Plastic Surgical Group, PC
Garden City, New York, United States, 11530
4
Cancer Center of America at Eastern Regional Medical Center / Dr. Glat Plastic & Reconstructive Surgery
Bala-Cynwyd, Pennsylvania, United States, 19004