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

RecruitingNAAges 21 Years - anyAllAvvio Medical
NCT06942949 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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)
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What it tests

  • ELS (Enhanced Lithotripsy System)
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Where

20 sites
Arizona State Urological Research Institute
Phoenix, United States
Arkansas Urology Research Center
Little Rock, United States
Michael G. Oefelein Clinical Trials
Bakersfield, United States
San Diego Clinical Trials
La Mesa, United States
Golden State Urology
Sacramento, United States
University of Miami Hospital
Miami, United States
Georgia Urology
Roswell, United States
Comprehensive Urologic Care
Lake Barrington, United States

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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