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

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. Subjects who still have stone present at Day 30 will be evaluated again at Day 60. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.

Inclusion Criteria:

• Male or Female aged >=21 Years
• Provides written informed consent
• One urinary stone within the ureter, size >=5 mm and <=10 mm present on CT
• Stone is indicated for Shock Wavve Lithotrips Per AUA 2026 guidelines
• Stone to be treated has a maximum density of <= 1200 HU

Exclusion Criteria:

• Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
• Non-calcium based stones (e.g., uric acid stones)
• Untreated UTI
• Presence of abnormal skin conditions in the area to be treated
• Coagulation abnormality
• Inability to lay still for 30 minutes
• Pregnant
• Abnormal Kidney Function
• Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)