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