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

A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones

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.

Inclusion Criteria:

• Individuals presenting with at least one kidney stone apparent on CT.
• Stones must be within the upper urinary tract.
• Stones are indicated for SWL treatment per the American Urology Association (AUA) 2016 guidelines.8
• Stones must be measured under CT to be within the AUA 2016 SWL guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones).

Exclusion Criteria:

• Acute untreated urinary tract infection or urosepsis.
• Uncorrected bleeding disorders or coagulopathies.
• Pregnancy.
• Uncorrected obstruction distal to the stone.
• 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.
• Solitary kidney
• 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.