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NCT06942949 · ClinicalTrials.gov registry record · NA
Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial
A NA study of Kidney Calculi; Ureteral Calculi, sponsored by Avvio Medical.
- Recruiting
- Registry status
- NA
- Development phase
- 101
- Enrollment target
- 16
- Study locations
NCT06942949: Recruiting NA study of Kidney Calculi; Ureteral Calculi, sponsored by Avvio Medical.
NCT06942949 is a NA study of Kidney Calculi; Ureteral Calculi that is actively recruiting participants, run by Avvio Medical. The registered enrollment target is 101 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06942949, a NA study of Kidney Calculi; Ureteral Calculi, is actively recruiting participants, sponsored by Avvio Medical.
- RECRUITING
- Registry status
- NA
- Development phase
- 101 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE ELS (Enhanced Lithotripsy System)
Study Locations (16)
California
- Michael G. Oefelein Clinical Trials - Bakersfield
- San Diego Clinical Trials - La Mesa
- Golden State Urology - Sacramento
Virginia
- University of Virginia - Charlottesville
- University of Virginia Community Health - Culpeper
- Urology of Virginia - Virginia Beach
New York
- University of Rochester Medical Center - Rochester
- SUNY - Upstate Medical University - Syracuse
Arizona
- Arizona State Urological Research Institute - Phoenix
Florida
- University of Miami Hospital - Miami
Georgia
- Georgia Urology - Roswell
Illinois
- Comprehensive Urologic Care - Lake Barrington
Kansas
- Wichita Urology Group - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2025-05-01 |
| Est. Completion | 2026-07 |
| Phase | NA |
What NCT06942949 shows while recruiting
NCT06942949 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Kidney Calculi; Ureteral Calculi appearing as the primary indexed condition, and to 1 intervention - of which ELS (Enhanced Lithotripsy System) is the first listed.
NCT06942949 lists 16 locations in 11 states (California, Virginia, New York).
Frequently Asked Questions
What is clinical trial NCT06942949 about?
NCT06942949 is a clinical study titled "Evaluation of Enhanced Lithotripsy System (ELS) in the Treatment of Urinary Stones, A Pivotal Trial". 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, wit...
What is the current status of trial NCT06942949?
This trial is currently recruiting. It is a NA study. The enrollment target is 101 participants. The study started on 2025-05-01. Estimated completion is 2026-07.
What conditions does trial NCT06942949 study?
This clinical trial studies the following conditions: Kidney Calculi; Ureteral Calculi.
What interventions are being tested in trial NCT06942949?
The interventions under investigation include: ELS (Enhanced Lithotripsy System) (DEVICE).
Who is sponsoring clinical trial NCT06942949?
This trial is sponsored by Avvio Medical, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06942949 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06942949's enrollment target sits among peer trials
101 840th of 2000 higher than 1,161 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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