Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
Eligible age
21+ yrs
Accepts
All genders
Locations
15 states
Healthy volunteers
No
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About this study
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.
Sponsor: Avvio Medical
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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
Where it's recruiting
Source: ClinicalTrials.gov · NCT06942949 · last updated 2026-06-16