Status:
RECRUITING
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
Lead Sponsor:
Avvio Medical
Conditions:
Kidney Calculi; Ureteral Calculi
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
- Medical Expulsion Therapy (e.g., Flomax)
- 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)
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT06942949
Start Date
May 1 2025
End Date
October 1 2025
Last Update
October 1 2025
Active Locations (15)
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1
Arizona State Urological Research Institute
Phoenix, Arizona, United States, 85225
2
Michael G. Oefelein Clinical Trials
Bakersfield, California, United States, 93301
3
San Diego Clinical Trials
La Mesa, California, United States, 91942
4
Golden State Urology
Sacramento, California, United States, 95823