Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
ELS
1 other identifier
interventional
101
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2025
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 24, 2025
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
ExpectedFebruary 2, 2026
April 1, 2025
1 year
April 17, 2025
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome Measure
CT assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (\<=4 mm) at 30 Days post procedure.
From ELS treatment to 30 Days afterward.
Study Arms (1)
The ELS Trial is a prospective, multi-center, single arm study.
EXPERIMENTALAll Subjects who qualify to participate in the ELS Trial will receive the experimental ELS procedure.
Interventions
ELS (Enhanced Lithotripsy System) utilizes low pressure ultrasound to actuate proprietary microbubbles administered into the urine to pit and fragment urinary stones.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Avvio Medicallead
Study Sites (16)
Arizona State Urological Research Institute
Phoenix, Arizona, 85225, 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
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 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 24, 2025
Study Start
May 1, 2025
Primary Completion
May 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
February 2, 2026
Record last verified: 2025-04