Evaluating the Safety and Effectiveness of OviTex PRS Device in Breast Reconstruction Surgery for Women

What this Trial Is About

Researchers are evaluating the safety and effectiveness of OviTex PRS, a device made from a multi-layer construct of extracellular matrix derived from ovine forestomach and embroidered with polymer filament, in patients undergoing implant-based breast reconstruction. The study focuses on women aged 22 to 75 who are having their first immediate unilateral or bilateral direct-to-implant pre-pectoral breast reconstruction after mastectomy for cancer or cancer prevention. The trial is sponsored by Tela Bio Inc and aims to monitor reconstructive failure and major complications over 12 months. Participants receive the OviTex PRS device during their breast reconstruction surgery. The study includes careful consideration of who can participate, excluding those with certain medical conditions, prior breast surgeries, or specific treatment histories. The trial does not involve blinding or placebo groups and follows patients for 12 months to assess outcomes after the surgery. During the study, participants will attend follow-up visits for clinic evaluations, complete questionnaires, and have photographs taken to track their progress. Researchers will measure reconstructive failure rates and major complications from enrollment through one year post-surgery. Participants must be able to comply with study visits and requirements, and safety monitoring will continue throughout the study duration.

Effectiveness and Safety of OviTex® PRS in Breast Reconstruction