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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Primary Effectiveness Outcome - Stone Fragmentation — 12 weeks post-treatment
  Stone fragmentation as determined by stone passage or imaging confirmation.
• Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia — 12 weeks post-treatment
  The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.

Trial sites (6)

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