Evaluation of a new system for breaking down urinary stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of the Enhanced Lithotripsy System (ELS) for treating urinary stones. The ELS aims to fragment stones into smaller pieces that can be passed more easily, potentially reducing discomfort during the procedure. Eligible participants, aged 21 and older with a single ureteral stone, will undergo the ELS procedure and be assessed 30 days later using a CT scan to check for stone fragments. Additional outcomes include measuring changes in pain levels, quality of life, and the ability to return to normal activities.

Why it matters

Who can join: the full rules

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)

Where it's running

• Arizona State Urological Research Institute
  Phoenix, Arizona, United States Recruiting
• San Diego Clinical Trials
  La Mesa, California, United States Recruiting
• Golden State Urology
  Sacramento, California, United States Recruiting
• University of Miami Hospital
  Miami, Florida, United States Recruiting
• Georgia Urology
  Roswell, Georgia, United States Recruiting
• Comprehensive Urologic Care
  Lake Barrington, Illinois, United States Recruiting

Study contacts

• Study coordinator: Louis Marcoux
• Email: louis.marcoux@avviomed.com
• Phone: 415-887-2037

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.