Study of the SonoMotion Break Wave System to Treat Kidney and Urinary Tract Stones Using Ultrasound

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the SonoMotion Break Wave device to break stones in the upper urinary tract. This prospective, open-label, multi-center, single-arm study will include up to 30 participants with stones sized up to 10 mm in the lower pole and up to 20 mm elsewhere. The study focuses on assessing safety through self-reported adverse events and emergency visits, as well as stone fragmentation measured by stone passage and CT image comparison. Participants will receive the investigational Break Wave procedure, which uses low amplitude ultrasound waves focused on the kidney stone via a specialized therapy probe with an integrated ultrasound imaging probe for guidance. The procedure is performed in hospital surgical environments as outpatient care or in non-surgical settings such as clinics. Anesthesia levels may vary from none to general anesthesia during the procedure. During the study, participants will be monitored for safety outcomes including hematoma, urinary tract infection, or heart rhythm issues over 12 weeks post-treatment. Effectiveness will be evaluated by stone fragmentation, stone free status, and residual fragment size using CT scans and self-reports. Follow-up procedures, including CT scans and adverse event tracking, will assess safety and treatment outcomes throughout the 12-week period after the procedure.

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