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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
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.
University of California San Diego Health
San Diego, California, United States
COMPLETEDUniversity of California, San Francisco
San Francisco, California, United States
COMPLETEDUniversity of Washington Medical Center
Seattle, Washington, United States
COMPLETEDUniversity of Alberta, Division of Urology
Edmonton, Alberta, Canada
COMPLETEDVancouver General Hospital Stone Centre
Vancouver, British Columbia, Canada
RECRUITINGSt. Michael's Unity Health Toronto
Toronto, Ontario, Canada
NOT_YET_RECRUITINGPrimary Effectiveness Outcome - Stone Fragmentation
Stone fragmentation as determined by stone passage or imaging confirmation.
Time frame: 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.
Time frame: 12 weeks post-treatment
Secondary effectiveness outcome - Stone Free Status
Radiographic evidence (CT imaging) of stone free status.
Time frame: 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).
Time frame: 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)
Time frame: 12 weeks post-treatment
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