What is the Purpose of this Study?
The objective of this study is to evaluate the safety and effectiveness of ARTIA in subjects undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy, for cancer treatment or prophylaxis, using a prepectoral technique. The hypotheses are: ? ARTIA is associated with a lower rate of major complications related to the breast reconstruction when compared to breast reconstruction without ADM. ? Subjects report a change from pre-operative "BREAST-Q Satisfaction with Breasts" score to Month 12 after Stage 2 similar to those undergoing breast reconstruction without ADM.
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