Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
The purpose of this study is to evaluate the safety and performance of the ELS to treat urinary stones. The ELS is intended to break urinary stones into small fragments that can pass during or after the procedure with less or no discomfort. Eligible patients are male or females, age 21 or older, with a single urinary stone in the ureter. Participants will undergo the ELS procedure and then be evaluated 30 days later for the presence or absence of urinary stone fragments on a CT scan. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.
• Male or Female aged \>=21 Years
• Provides written informed consent
• One urinary stone within the ureter, size \>=5 mm and \<=10 mm
• Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines
• Urinary stone is present on a CT scan within past 14 days