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

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.

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Key information

Conditions

Kidney Calculi; Ureteral Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ureteral Calculi Ureteral Diseases Ureterolithiasis Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State Urological Research Institute, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

ELS (Enhanced Lithotripsy System)

Device

ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones.

Primary outcomes

Primary Outcome Measure

Time frame: From ELS treatment to 30 Days afterward.

CT assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (<=4 mm) at 30 Days post procedure.

Study contacts

Contact information is provided by the study sponsor or research team.

Louis Marcoux

CONTACT

[email protected]

415-887-2037

Sponsors and collaborators

Lead sponsor

Avvio Medical

Industry

Registry information

Acronym: ELS

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Apr 24, 2025
Registry last updated: Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed