Break Wave extracorporeal lithotripsy to break kidney stones
A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones
This trial will try the Break Wave machine to break upper urinary tract stones up to 20 mm (10 mm in the lower pole) in adults as an outpatient procedure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | SonoMotion Industry-sponsored |
| Locations | 6 sites (San Diego, California and 5 other locations) |
| Trial ID | NCT03811171 on ClinicalTrials.gov |
What this trial studies
This is a prospective, open-label, multi-center, single-arm first-in-human study enrolling up to 30 subjects to test the SonoMotion Break Wave extracorporeal lithotripter. Procedures are performed in hospital outpatient or non-surgical clinic/office settings under varying anesthesia from none to general anesthesia. Safety will be tracked by patient-reported adverse events, unplanned ED or clinic visits, and any need for additional interventions. Stone fragmentation and passage will be measured by patient reports and comparison of pre- and post-procedure CT images.
Who should consider this trial
Good fit: Adults with at least one CT-visible upper urinary tract stone that meets AUA SWL size limits (≤10 mm for lower pole stones, ≤20 mm elsewhere), who can undergo outpatient treatment and complete required follow-up including post-procedure CT.
Not a fit: Patients with untreated urinary infection, uncorrected bleeding disorders, pregnancy, distal obstruction, stones not visible or positionable for the device, or those unwilling to stop anticoagulants or comply with follow-up are unlikely to benefit.
Why it matters
Potential benefit: If successful, it could offer a noninvasive outpatient option to fragment certain kidney stones with potentially faster recovery and less need for invasive procedures.
How similar studies have performed: Traditional shock wave lithotripsy has a long record of success for appropriately sized stones, but this is the first-in-human trial of the Break Wave device specifically.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
San Diego, California and 5 other locations
- University of California San Diego Health — San Diego, California, United States (Completed)
- University of California, San Francisco — San Francisco, California, United States (Completed)
- University of Washington Medical Center — Seattle, Washington, United States (Completed)
- University of Alberta, Division of Urology — Edmonton, Alberta, Canada (Completed)
- Vancouver General Hospital Stone Centre — Vancouver, British Columbia, Canada (Recruiting)
- St. Michael's Unity Health Toronto — Toronto, Ontario, Canada (Not_yet_recruiting)
Study contacts
- Study coordinator: Oren Levy, PhD
- Email: oren.levy@sonomotion.com
- Phone: 4156722631
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.