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Sound waves zap kidney stones: no needle, no knife needed

NCT ID NCT04796792

Disease control Sponsor: University of Washington 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new ultrasound device that can break kidney stones into tiny pieces and reposition them, all without anesthesia. Researchers will enroll 140 people with small kidney stones to see if the procedure is safe and helps stones pass naturally. The goal is to offer a gentler alternative to surgery or shock wave therapy.

What this could mean

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

Active substance
Ultrasound device (Burst Wave Lithotripsy and Ultrasonic Propulsion)
What this could lead to
If successful, this could offer a non-invasive, anesthesia-free way to break up and reposition kidney stones, helping them pass more easily and reducing the need for surgery.
What could go wrong
This is an early feasibility study with only 140 participants, so results may not apply to everyone. The technology may not effectively fragment all stone types, and there is a risk of side effects like pain or injury.

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 140 people

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

Started

Apr 2023

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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

Accepted

You do not need to have the condition being studied to take part.

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: * Individuals presenting with at least one kidney stone * Stone with maximum dimension \> 2 mm and ≤ 7 mm as determined by clinical imaging * Individuals with SCI - (Phase 2b only) Exclusion Criteria: * Individuals under 18 years of age * Individuals who are pregnant or who are trying to get pregnant * Prisoners * with cognitive impairment that would limit their ability to comprehend their role in consent or participation. * Individuals who are unable to read or understand English * Individuals who are unable or unwilling to participate in follow up activities * Individuals who cannot be positioned for ultrasound imaging * Individuals with uncorrected bleeding disorders or coagulopathies * Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure * Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure * Individuals with a solitary kidney * Individuals with an uncorrected urinary tract obstruction * Individuals with an untreated infection * Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure * Individuals who have received two previous investigational procedures for the same stone target * Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.

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Conditions

The condition(s) this trial relates to.

nephrolithiasis Urinary Calculi urolithiasis

As listed by the trial registrant

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

Urinary calculi Urinary stone

How to take part

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

  1. The places running it

    2 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

  • Indiana University Health - North Hospital

    WITHDRAWN

    Carmel, Indiana, 46032, United States

  • University of Washington

    RECRUITING

    Seattle, Washington, 98195, United States

  • VA Puget Sound Health Care System

    RECRUITING

    Seattle, Washington, 98108, United States

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