An interventional study of Break Wave extracorporeal lithotripsy in Kidney Stone, Urolithiasis and Nephrolithiasis, sponsored by SonoMotion. Completed at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by SonoMotion · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones.
Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to demonstrate the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave™ technology. Up to 116 patients will be screened to participate. Depending on the institution, the procedure may be performed in an outpatient hospital surgical environment, or in a non-surgical environment such as a clinic or office procedure room. Subjects will have a target stone diagnosed to be >4millimeter (mm) to 10 mm in size.
Safety will be measured by the adverse event occurrence, unplanned emergency department or clinic visits, and the need for further intervention. Effectiveness will be determined by the size of fragments identified at the 10 week follow-up imaging.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's enrollment of 64 is below the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →SonoMotion is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The subject will undergo the Break Wave procedure.
Device: Break Wave extracorporeal lithotripsy
The Break Wave device will be used to exert a low amplitude burst of ultrasound waves focused at the kidney stone. The primary components of the device include an ultrasound imaging system and a therapy probe driven by a high voltage generator. The probe will be placed on the patient's skin, the stone located via diagnostic ultrasound and up to 30 minutes of therapy will be delivered to the stone. The therapy probe accommodates coaxial alignment of an ultrasound imaging probe for treatment guidance.
Primary Effectiveness Endpoint
Proportion of subjects with a radiographic 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).
Time frame: 10 +/- 2 weeks post final Break Wave procedure
Primary Safety Endpoint
Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia
Time frame: During procedure and through 90 days post-procedure
Secondary safety endpoint
Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs)
Time frame: During procedure and through 90 days post-procedure
Plan to share: No
Ran from Oct 2023 to primary completion in Jun 2025, 20 months.
Of 199 interventional studies with no phase under Kidney Calculi, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 51. This study's 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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