Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSonoMotion
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
Acute untreated urinary tract infection or urosepsis.
Uncorrected bleeding disorders or coagulopathies.
Pregnancy.
Uncorrected obstruction distal to the stone.
Trial design
Design model
Single group
Treatments tested in this trial
Break Wave extracorporeal lithotripsy
DeviceThe 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.
Treatment groups
70 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Primary Effectiveness Outcome - Stone Fragmentation
Stone fragmentation as determined by stone passage or imaging confirmation.
Time frame
12 weeks post-treatment2
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-treatmentSecondary outcomes
1
Secondary effectiveness outcome - Stone Free Status
Radiographic evidence (CT imaging) of stone free status.
Time frame
12 weeks post-treatment2
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-treatment3
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-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
SonoMotion
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov