Actively Recruiting
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Led by SonoMotion · Updated on 2025-07-29
70
Participants Needed
6
Research Sites
397 weeks
Total Duration
On this page
Sponsors
S
SonoMotion
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals presenting with at least one kidney stone apparent on CT
- Stones must be within the upper urinary tract
- Stones indicated for shock wave lithotripsy treatment per American Urology Association 2016 guidelines
- Stones must be 10 mm or smaller for lower pole stones and 20 mm or smaller for other locations as measured by CT
You will not qualify if you...
- Acute untreated urinary tract infection or urosepsis
- Uncorrected bleeding disorders or coagulopathies
- Pregnancy
- Uncorrected obstruction distal to the stone
- Patients on anticoagulants unable or unwilling to stop medication for the procedure
- Stones not visible on ultrasound or cannot be positioned within the therapy focus
- Individuals in vulnerable groups (pregnant, mentally disabled, prisoner, etc.)
- Patients unwilling to comply with follow-up protocol including post-procedure CT
- Individuals under 18 years of age
- Anatomical issues preventing adequate positioning or delivery of the therapy
- Calcified abdominal aortic or renal artery aneurysms
- Solitary kidney
- Comorbidities or anatomical anomalies making the patient a poor candidate as determined by physician
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
University of California San Diego Health
San Diego, California, United States, 92103
Completed
2
University of California, San Francisco
San Francisco, California, United States, 94143
Completed
3
University of Washington Medical Center
Seattle, Washington, United States, 98195
Completed
4
University of Alberta, Division of Urology
Edmonton, Alberta, Canada, T6G1Z1
Completed
5
Vancouver General Hospital Stone Centre
Vancouver, British Columbia, Canada, BC V5Z 1M9
Actively Recruiting
6
St. Michael's Unity Health Toronto
Toronto, Ontario, Canada, M5C 2T2
Not Yet Recruiting
Research Team
O
Oren Levy, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here