Break Wave extracorporeal lithotripsy to break kidney stones

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Vancouver General Hospital Stone Centre
  Vancouver, British Columbia, Canada Recruiting
• 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
• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.