Status:
RECRUITING
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Lead Sponsor:
SonoMotion
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Renal Calculi
Urinary Calculi
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2027
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03811171
Start Date
August 20 2019
End Date
March 30 2027
Last Update
July 29 2025
Active Locations (6)
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1
University of California San Diego Health
San Diego, California, United States, 92103
2
University of California, San Francisco
San Francisco, California, United States, 94143
3
University of Washington Medical Center
Seattle, Washington, United States, 98195
4
University of Alberta, Division of Urology
Edmonton, Alberta, Canada, T6G1Z1