Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ELS (Enhanced Lithotripsy System).
- Who it may be relevant to
- Registry conditions: Kidney Calculi; Ureteral Calculi. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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.
Primary outcome measures
- Primary Outcome Measure [Time frame: From ELS treatment to 30 Days afterward.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Arizona State Urological Research Institute — Phoenix
- Arkansas Urology Research Center — Little Rock
- Michael G. Oefelein Clinical Trials — Bakersfield
- San Diego Clinical Trials — La Mesa
- Golden State Urology — Sacramento
- University of Miami Hospital — Miami
- Georgia Urology — Roswell
- Comprehensive Urologic Care — Lake Barrington
- … and 12 more centers
Identifiers
NCT: NCT06942949 · CIP-0002