Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial

Not Applicable

Recruiting

• Conditions: Kidney Calculi; Ureteral Calculi

• Registration Number: NCT06942949
• Lead Sponsor: Avvio Medical

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. Other outcome measures will be changes in pain, quality of life, and return to normal daily activities/work.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Study First Posted: 2025-04-24
• Study Start: 2025-05-01
• Last Update Submitted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2025-10
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Male or Female aged >=21 Years
• Provides written informed consent
• One urinary stone within the ureter, size >=5 mm and <=10 mm
• Stone is indicated for Shock Wavve Lithotrips Per AUA 2016 guidelines
• Urinary stone is present on a CT scan within past 14 days

Exclusion Criteria

• Anatomic presentations that would preclude obtaining an acoustic window for the ultrasound treatment
• Medical Expulsion Therapy (e.g., Flomax)
• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	From ELS treatment to 30 Days afterward.	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.

Trial Locations

Locations (10)

Michael G. Oefelein Clinical Trials; 🇺🇸 Bakersfield, California, United States

University of Miami Hospital; 🇺🇸 Miami, Florida, United States

Duke; 🇺🇸 Durham, North Carolina, United States

Urology of Virginia; 🇺🇸 Virginia Beach, Virginia, United States

Arizona State Urological Research Institute; 🇺🇸 Phoenix, Arizona, United States

Golden State Urology; 🇺🇸 Sacramento, California, United States

Comprehensive Urologic Care; 🇺🇸 Lake Barrington, Illinois, United States

Wichita Urology Group; 🇺🇸 Wichita, Kansas, United States

Sheldon Freedman, MD; 🇺🇸 Las Vegas, Nevada, United States

Urology San Antonio; 🇺🇸 San Antonio, Texas, United States