Study to Test Safety and Effectiveness of ARTIA Tissue Matrix for Immediate, Two-Stage Implant Breast Reconstruction After Mastectomy in Adults

What this Trial Is About

This trial evaluates the safety and effectiveness of ARTIA Reconstructive Tissue Matrix in adult women undergoing immediate, two-stage implant-based breast reconstruction following mastectomy. The study focuses on participants having either unilateral or bilateral mastectomy and aims to assess outcomes related to breast reconstruction complications and participant satisfaction. Participants will receive breast reconstruction using the ARTIA Tissue Matrix device in a two-stage prepectoral implant-based procedure. The study is open-label, non-randomized, and conducted across multiple centers. The follow-up includes monitoring for major complications after the first stage and adverse events for up to approximately 36 months. Throughout the study, participants will be monitored for complications related to breast reconstruction, reconstructive failure, capsular contracture, and changes in satisfaction with breasts using the BREAST-Q score. Safety assessments and adverse event tracking will continue up to three years. The total study duration extends until February 2031, with primary outcome assessments at 18 months and secondary measures up to 36 months.

Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants