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Break Wave Extracorporeal Lithotripter for Kidney Stones

This study is testing a new device called Break Wave extracorporeal lithotripsy to see if it can safely and effectively break up kidney stones (renal calculi) in the upper urinary tract. The Break Wave device uses low-amplitude ultrasound waves focused on the stone. Researchers will look at how well the stones break apart and if there are any serious side effects like bleeding (hematoma), infection (urinary tract sepsis), or heart rhythm problems (cardiac arrhythmia). You might be able to join if you have at least one kidney stone in your upper urinary tract that is 10mm or smaller for lower pole stones, or 20mm or smaller for other stones, as seen on a CT scan. The study aims to enroll up to 30 people, but the current recruitment status is unclear.

Study design
This is a single-arm study, meaning everyone receives the Break Wave treatment. It is open-label, so both you and the study team will know you are receiving the treatment. Up to 30 people will be included.
What's involved
The procedure will be performed in a hospital or clinic setting, and you may or may not receive anesthesia. The study will measure stone fragmentation and safety outcomes at 12 weeks after treatment.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for 12 weeks after the treatment to assess stone fragmentation and safety.

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NCT03811171

Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

Recruiting
NAAges 18+InterventionalTreatment
SonoMotion
~70 participants
Updated 2025-07-29 on ClinicalTrials.gov
What's tested:Break Wave extracorporeal lithotripsy

At a glance

Recruiting sites
1 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Effectiveness Outcome - Stone Fragmentation
Measured over 12 weeks post-treatment
+1 more outcome measured

Conditions

Renal Calculi
Urinary Calculi

Explore related trials

Nephrolithiasis

Where it's being run

6 sites across 5 states
California2
Washington1
Alberta1
British Columbia1
Ontario1

Who to contact

Oren Levy, PhD
[email protected]
4156722631
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Individuals presenting with at least one kidney stone apparent on CT.
Stones must be within the upper urinary tract.
Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).

Exclusion

Acute untreated urinary tract infection or urosepsis.
Uncorrected bleeding disorders or coagulopathies.
Pregnancy.
Uncorrected obstruction distal to the stone.
Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
Individuals under 18 years of age.
Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
Solitary kidney
Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.

What this trial measures

  • Primary Effectiveness Outcome - Stone Fragmentation12 weeks post-treatment

    Stone fragmentation as determined by stone passage or imaging confirmation.

  • Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia12 weeks post-treatment

    The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.