What is the Purpose of this Study?
The purpose of this study is to evaluate the safety and effectiveness of an experimental product called the ARTIA Reconstructive Tissue Matrix when used in immediate, implant-based, two-stage breast reconstruction following mastectomy for cancer treatment or prophylaxis (prevention), using a prepectoral technique (placing the implant over the chest muscle). The ARTIA is intended to reinforce soft tissue in breast reconstruction surgery. In a mastectomy that has spared the breast skin, surgeons can perform immediate reconstruction of the breast using this skin to cover the implanted tissue expander. Patients enrolled at Cedars-Sinai will be assigned to the ARTIA group and will receive prepectoral breast reconstruction in which the study device is used to cover the tissue expander before covering it with the patient’s breast skin. No tissues or muscles will be used to cover the tissue expander in these patients.
Eligibility
- * Participants who will undergo unilateral or bilateral mastectomy upon enrollment.
- * Participants who are willing and able to undergo immediate pre-pectoral two-stage breast reconstruction with ARTIA or without ADM.
Where can I participate?
Beverly
More about this Clinical Trial
What is the full name of this clinical trial?
A Prospective, Multicenter, Open-Label, Non-Randomized, Controlled Pivotal Study to Evaluate the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix in Implant-Based Two-Stage Prepectoral Breast Reconstruction Post-Mastectomy