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.
A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
Patients receiving anticoagulants and who are unable or not willing to cease the medication for the Break Wave procedure.
Stones that are not echogenically visible or cannot be positioned within the Break Wave therapy focus.
Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.).
Patients unwilling to comply with the follow-up protocol, including post-procedure CT.
Individuals under 18 years of age.
Anatomic presentations preventing adequate positioning or delivery of the Break Wave pulse.
Calcified abdominal aortic aneurysms or calcified renal artery aneurysms.
Comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
University of California San Diego Healthaccepting new patients San Diego California 92103 United States
University of California, San Franciscoaccepting new patients San Francisco California 94143 United States