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

Study Overview
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Brief Summary
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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.

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

Conditions
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Renal Calculi, Urinary Calculi

Intervention / Treatment
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* Device: Break Wave extracorporeal lithotripsy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>The arm receives the investigational Break Wave procedure. | Device: Break Wave extracorporeal lithotripsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary effectiveness outcome - Stone Free Status | Radiographic evidence (CT imaging) of stone free status. | 12 weeks post-treatment | 
| Secondary effectiveness outcome - Residual fragment size | Presence of only stone fragments small enough to pass (less than or equal to 4 mm). | 12 weeks post-treatment | 
| Secondary safety outcome - Adverse events | documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL) | 12 weeks post-treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stone, Lithotripsy, Calculi