NCT06942949

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (estimated)
• Sponsor: Avvio Medical · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Calculi; Ureteral Calculi

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-05-01
• Completion: 2026-07-01
• First posted: 2025-04-24
• Last updated: 2026-02-02

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study