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Bubble blast: new device aims to shatter kidney stones without surgery

NCT ID NCT06942949

Disease control Sponsor: Avvio Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the Enhanced Lithotripsy System (ELS) that uses low-pressure ultrasound to activate tiny bubbles in the urine, breaking kidney or ureter stones into small pieces that can pass naturally. The trial will enroll 101 adults with a single stone in the ureter. Participants receive the ELS procedure and are checked with a CT scan 30 days later to see if the stone is gone or reduced to fragments small enough to pass.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Enhanced Lithotripsy System (ELS) device with microbubbles
What this could lead to
If it works, this could offer a less painful way to break up urinary stones so they pass naturally, reducing the need for surgery.
What could go wrong
This is a small, early-stage trial with only 101 people. The device may not break stones effectively for everyone, and some may still need additional procedures.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 101 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

Kidney Calculi Ureteral Calculi ureterolithiasis urolithiasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Kidney calculi; ureteral calculi

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona State Urological Research Institute

    RECRUITING

    Phoenix, Arizona, 85225, United States

  • Arkansas Urology Research Center

    ENROLLING_BY_INVITATION

    Little Rock, Arkansas, 72211, United States

  • Comprehensive Urologic Care

    RECRUITING

    Lake Barrington, Illinois, 60010, United States

  • Duke

    ACTIVE_NOT_RECRUITING

    Durham, North Carolina, 27710, United States

  • Georgia Urology

    RECRUITING

    Roswell, Georgia, 300076, United States

  • Golden State Urology

    RECRUITING

    Sacramento, California, 95823, United States

  • Michael G. Oefelein Clinical Trials

    ACTIVE_NOT_RECRUITING

    Bakersfield, California, 93301, United States

  • Minnesota Urology

    RECRUITING

    Woodbury, Minnesota, 55125, United States

  • Nebraska Urology

    ENROLLING_BY_INVITATION

    Lincoln, Nebraska, 68516, United States

  • SUNY - Upstate Medical University

    RECRUITING

    Syracuse, New York, 13210, United States

  • San Diego Clinical Trials

    RECRUITING

    La Mesa, California, 91942, United States

  • University of Miami Hospital

    RECRUITING

    Miami, Florida, 33136, United States

  • University of Rochester Medical Center

    RECRUITING

    Rochester, New York, 14620, United States

  • University of Virginia

    WITHDRAWN

    Charlottesville, Virginia, 22903, United States

  • University of Virginia Community Health

    ACTIVE_NOT_RECRUITING

    Culpeper, Virginia, 22701, United States

  • Urology Nevada

    ENROLLING_BY_INVITATION

    Reno, Nevada, 89511, United States

  • Urology San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Urology Specialists Clinic

    ENROLLING_BY_INVITATION

    Sioux City, South Dakota, 57108, United States

  • Urology of Virginia

    RECRUITING

    Virginia Beach, Virginia, 23462, United States

  • Wichita Urology Group

    RECRUITING

    Wichita, Kansas, 67226, United States

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