An interventional study of Break Wave extracorporeal lithotripsy in Renal Calculi and Urinary Calculi, sponsored by SonoMotion. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by SonoMotion · Not applicable, Interventional, and Treatment
This is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave technology. Up to 30 subjects will be included. The procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. The procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). Stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else.
Safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. Fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (CT) images before and after the procedure.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 70 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.
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Exclusion Criteria:
The arm receives the investigational 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 85 mm aperture diameter therapy probe driven by a high voltage generator. The therapy probe has a cavity in the middle to accommodate coaxial alignment of an ultrasound imaging probe for treatment guidance.
Primary Effectiveness Outcome - Stone Fragmentation
Stone fragmentation as determined by stone passage or imaging confirmation.
Time frame: 12 weeks post-treatment
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
Time frame: 12 weeks post-treatment
Secondary effectiveness outcome - Stone Free Status
Radiographic evidence (CT imaging) of stone free status.
Time frame: 12 weeks post-treatment
Secondary effectiveness outcome - Residual fragment size
Presence of only stone fragments small enough to pass (less than or equal to 4 mm).
Time frame: 12 weeks post-treatment
Secondary safety outcome - Adverse events
documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL)
Time frame: 12 weeks post-treatment
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Plan to share: No
Started Aug 2019 (actual). Primary completion is estimated for Jan 2027, 89 months after the start.
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 planned 89 months is above that.
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