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Renal Calculi clinical trials at UCSD
1 research study open to eligible people

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

    open to eligible people ages 18 years and up

    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 the operating room under varying levels of anesthesia. 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.

    San Diego, California and other locations

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