Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
Recruiting now · Not applicable
Conditions studied: Kidney Calculi; Ureteral Calculi
In brief
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.
Key facts
- Study ID
- NCT06942949
- Run by
- Avvio Medical
- People needed
- 101
- Starts
- 2025-05-01
- Expected to finish
- 2026-09-01
- Last updated by the study team
- 2026-06-16
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
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
- Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)
Where it is running
- Urology of Virginia — Virginia Beach, Virginia, United States (enrolling)
- Arizona State Urological Research Institute — Phoenix, Arizona, United States (enrolling)
- University of Miami Hospital — Miami, Florida, United States (enrolling)
- Georgia Urology — Roswell, Georgia, United States (enrolling)
- Comprehensive Urologic Care — Lake Barrington, Illinois, United States (enrolling)
- Wichita Urology Group — Wichita, Kansas, United States (enrolling)
- Minnesota Urology — Woodbury, Minnesota, United States (enrolling)
- University of Rochester Medical Center — Rochester, New York, United States (enrolling)
- SUNY - Upstate Medical University — Syracuse, New York, United States (enrolling)
- Urology San Antonio — San Antonio, Texas, United States (enrolling)
- San Diego Clinical Trials — La Mesa, California, United States (enrolling)
- Golden State Urology — Sacramento, California, United States (enrolling)
- Arkansas Urology Research Center — Little Rock, Arkansas, United States
- Michael G. Oefelein Clinical Trials — Bakersfield, California, United States
- Urology Specialists Clinic — Sioux City, South Dakota, United States
- Nebraska Urology — Lincoln, Nebraska, United States
- Urology Nevada — Reno, Nevada, United States
- University of Virginia — Charlottesville, Virginia, United States
- University of Virginia Community Health — Culpeper, Virginia, United States
- Duke — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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