4 results
This is a feasibility study of the Balloon-based Focal Cryoablation System to assess safety and performance in patients with a Barretts esophagus
The study is designed to clinically demonstrate device acute safety (Primary Endpoint) along with longer FU device safety and effectiveness evaluation (Secondary Endpoint).The main objectives of the study areU :1) Evaluate the Acute safety of the…
This study will evaluate the efficacy of the CbFAS with the optimal safe dose on the conversion of Barrett's epithelium to healthy squamous cell epithelium in a larger cohort. Furthermore, the device performance of the improved CbFAS will be…
This IDE trial is proposed herein to gather clinical data on the safety and effectiveness of a hybridsinus node sparing ablation procedure utilizing the AtriCure ISOLATOR Synergy Surgical AblationSystem to obtain an IST indication.