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.

NCT Number	NCT06942949
Lead Sponsor	Avvio Medical
Conditions	Kidney Calculi; Ureteral Calculi
Enrollment	101 participants
Start Date	2025-05-01
Primary Completion	2026-08 (estimated)
Study Completion	2026-09 (estimated)
Updated on ClinicalTrials.gov	2026-06-16