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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.

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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.

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

FieldValue
Enrollment Target 101 participants
Start Date 2025-05-01
Est. Completion 2026-07
Phase NA
Avvio Medical

2 total trials

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.

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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Source: ClinicalTrials.gov NCT06942949, the US trial registry maintained by the National Library of Medicine. NCT06942949 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.