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NCT06942949NARecruiting

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

Avvio Medical

Start Date

5/1/2025

Completion Date

9/1/2026

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 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.

Eligibility Criteria

Age Range: 21 years to No maximum

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)

Interventions

DEVICE

ELS (Enhanced Lithotripsy System)

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Conditions

Kidney Calculi; Ureteral Calculi

Locations

Arizona State Urological Research Institute

Phoenix, Arizona 85225

United States

Arkansas Urology Research Center

Little Rock, Arkansas 72211

United States

Michael G. Oefelein Clinical Trials

Bakersfield, California 93301

United States

San Diego Clinical Trials

La Mesa, California 91942

United States

Golden State Urology

Sacramento, California 95823

United States

University of Miami Hospital

Miami, Florida 33136

United States

Georgia Urology

Roswell, Georgia 300076

United States

Comprehensive Urologic Care

Lake Barrington, Illinois 60010

United States

Wichita Urology Group

Wichita, Kansas 67226

United States

Minnesota Urology

Woodbury, Minnesota 55125

United States

Nebraska Urology

Lincoln, Nebraska 68516

United States

Urology Nevada

Reno, Nevada 89511

United States

University of Rochester Medical Center

Rochester, New York 14620

United States

SUNY - Upstate Medical University

Syracuse, New York 13210

United States

Duke

Durham, North Carolina 27710

United States

Urology Specialists Clinic

Sioux City, South Dakota 57108

United States

Urology San Antonio

San Antonio, Texas 78229

United States

University of Virginia

Charlottesville, Virginia 22903

United States

University of Virginia Community Health

Culpeper, Virginia 22701

United States

Urology of Virginia

Virginia Beach, Virginia 23462

United States