Testing the Safety and Effectiveness of the Enhanced Lithotripsy System Using Ultrasound to Break Urinary Stones in Adults

What this Trial Is About

This research aims to evaluate the safety and performance of the Enhanced Lithotripsy System ELS for treating urinary stones in adults. The study focuses on patients aged 21 or older who have a single urinary stone in the ureter. The purpose is to assess how well the ELS can break stones into small fragments that can pass more easily, potentially reducing discomfort. Participants will receive the ELS procedure, which uses low pressure ultrasound combined with microbubbles to pit and fragment the urinary stones. All participants undergo this experimental procedure, and no placebo or comparison group is involved. The study includes follow-up evaluations at 30 days and, if necessary, at 60 days to check for remaining stone fragments via CT scans. During the study, participants will be monitored for stone presence using CT imaging and assessed for changes in pain levels, quality of life, and return to normal daily activities and work. Safety and effectiveness will be evaluated up to 30 days after treatment, with an additional assessment at 60 days if stones remain. The total study duration extends from the procedure through these follow-up periods.

Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial