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Sound waves smash kidney stones without surgery

NCT ID NCT05701098

Disease control Sponsor: SonoMotion Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called Break Wave™ that uses focused ultrasound waves to break kidney stones into tiny pieces that can pass naturally. 64 adults with upper urinary tract stones (4-10 mm) received the treatment. The goal was to see if the device is safe and effective at fragmenting stones, with follow-up imaging at 10 weeks.

What this could mean

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

Active substance
Break Wave device (ultrasound waves to break kidney stones)
What this could lead to
If successful, this could offer a non-surgical option to break kidney stones, reducing the need for more invasive procedures.
What could go wrong
This is a small, completed trial with only 64 participants. The device may not work for all stone types or sizes, and there are risks like bleeding or infection.

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

64 people

The number who actually took part.

Started

Oct 2023

Finished

Jul 2025

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

18 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: 1. Subjects presenting with at least one stone apparent on radiographic imaging. 2. Target stone must be within the upper urinary tract. 3. Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines. 4. Target stone size is \> 4 mm and ≤ 10 mm. 5. Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits. 6. Target stone can be individually visualized from other stones. Exclusion Criteria: 1. Subject has an acute untreated urinary tract infection or urosepsis. 2. Subject has an uncorrected bleeding disorder or coagulation abnormality. 3. Subject is confirmed to be or suspected to be pregnant. 4. Subject has a urinary tract obstruction distal to the stone. 5. Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure 6. Subject has stones that are not echogenically visible with ultrasound. 7. Subject belongs to a vulnerable group (prisoner, etc.). 8. Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging. 9. Subject is under 18 years of age. 10. Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window). 11. Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms. 12. Subject has a solitary kidney. 13. Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage. 14. Subject is unable to read or comprehend the consent form.

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Conditions

The condition(s) this trial relates to.

Kidney Calculi nephrolithiasis Urinary Calculi urolithiasis

As listed by the trial registrant

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

Kidney calculi Kidney stone Nephrolith Nephrolithiasis Renal calculi Urinary calculi Urolithiasis

Contacts and locations

Locations

  • Kaiser Permanente

    Santa Clara, California, 95051, United States

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103, United States

  • Northwestern Medicine

    Chicago, Illinois, 60611, United States

  • St. Michael's Hospital, University of Toronto

    Toronto, Ontario, M5C 2T2, Canada

  • University of Alberta

    Edmonton, Alberta, T6G 1Z1, Canada

  • University of British Columbia

    Vancouver, British Columbia, Canada

  • University of California - San Francisco

    San Francisco, California, 94143, United States

  • University of California- San Diego

    San Diego, California, 92037, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Vanderbilt University

    Nashville, Tennessee, 37232, United States

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