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Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
Sponsor: Avvio Medical
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.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
101
Start Date
2025-05-01
Completion Date
2026-07
Last Updated
2026-02-02
Healthy Volunteers
No
Conditions
Interventions
ELS (Enhanced Lithotripsy System)
ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones.
Locations (16)
Arizona State Urological Research Institute
Phoenix, Arizona, United States
Michael G. Oefelein Clinical Trials
Bakersfield, California, United States
San Diego Clinical Trials
La Mesa, California, United States
Golden State Urology
Sacramento, California, United States
University of Miami Hospital
Miami, Florida, United States
Georgia Urology
Roswell, Georgia, United States
Comprehensive Urologic Care
Lake Barrington, Illinois, United States
Wichita Urology Group
Wichita, Kansas, United States
Minnesota Urology
Woodbury, Minnesota, United States
University of Rochester Medical Center
Rochester, New York, United States
SUNY - Upstate Medical University
Syracuse, New York, United States
Duke
Durham, North Carolina, United States
Urology San Antonio
San Antonio, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
University of Virginia Community Health
Culpeper, Virginia, United States
Urology of Virginia
Virginia Beach, Virginia, United States