Actively Recruiting
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
Led by Avvio Medical · Updated on 2026-02-02
101
Participants Needed
16
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female aged �3e=21 Years
- Provides written informed consent
- One urinary stone within the ureter, size �3e=5 mm and �3c=10 mm present on CT
- Stone is indicated for Shock Wave Lithotripsy per AUA 2026 guidelines
- Stone to be treated has a maximum density of �3c= 1200 HU
You will not qualify if you...
- Anatomic presentations that prevent obtaining an acoustic window for ultrasound treatment
- Non-calcium based stones (e.g., uric acid stones)
- Untreated urinary tract infection
- Presence of abnormal skin conditions in the treatment area
- Coagulation abnormalities
- Inability to lie still for 30 minutes
- Pregnancy
- Abnormal kidney function
- Any genitourinary history or procedure that has altered anatomy (e.g. urinary tract reconstruction)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Arizona State Urological Research Institute
Phoenix, Arizona, United States, 85225
Actively Recruiting
2
Michael G. Oefelein Clinical Trials
Bakersfield, California, United States, 93301
Actively Recruiting
3
San Diego Clinical Trials
La Mesa, California, United States, 91942
Actively Recruiting
4
Golden State Urology
Sacramento, California, United States, 95823
Actively Recruiting
5
University of Miami Hospital
Miami, Florida, United States, 33136
Actively Recruiting
6
Georgia Urology
Roswell, Georgia, United States, 300076
Actively Recruiting
7
Comprehensive Urologic Care
Lake Barrington, Illinois, United States, 60010
Actively Recruiting
8
Wichita Urology Group
Wichita, Kansas, United States, 67226
Actively Recruiting
9
Minnesota Urology
Woodbury, Minnesota, United States, 55125
Actively Recruiting
10
University of Rochester Medical Center
Rochester, New York, United States, 14620
Actively Recruiting
11
SUNY - Upstate Medical University
Syracuse, New York, United States, 13210
Actively Recruiting
12
Duke
Durham, North Carolina, United States, 27710
Actively Recruiting
13
Urology San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
14
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
15
University of Virginia Community Health
Culpeper, Virginia, United States, 22701
Actively Recruiting
16
Urology of Virginia
Virginia Beach, Virginia, United States, 23462
Actively Recruiting
Research Team
L
Louis Marcoux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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