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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and performance of the Enhanced Lithotripsy System (ELS) for treating urinary stones in adults aged 21 and older. The ELS uses low pressure ultrasound combined with microbubbles to break urinary stones into small fragments that can pass with minimal discomfort. The study focuses on patients with a single urinary stone located in the ureter, sized between 5 mm and 10 mm, and meeting specific density and treatment guidelines. Participants will receive the experimental ELS procedure designed to fragment stones using ultrasound activation of microbubbles in the urine. This is a single-arm trial where all qualifying patients undergo the ELS treatment. After the procedure, participants will be monitored primarily for the presence or absence of stone fragments using CT scans at 30 days, with a follow-up scan at 60 days if stones remain. During the study, participants will have CT scans to check stone status, and assessments will be made on changes in pain, quality of life, and return to daily activities or work. The study period includes evaluations at 30 days post-treatment and possibly at 60 days for those with remaining stones. The trial aims to observe safety and treatment effects without the use of a comparison group.
CONDITIONS
Brief 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 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive the experimental ELS procedure using low pressure ultrasound to fragment urinary stones.
1 procedure visit (in-person)
Duration - 30 days
Participants are monitored for safety and effectiveness for 30 days after the ELS treatment.
1 follow-up visit (in-person)
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
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