Recruiting

SonoMotion Break Wave

Sponsor:

SonoMotion

Code:

NCT03811171

Conditions

Renal Calculi

Urinary Calculi

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Break Wave extracorporeal lithotripsy

Study Details

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 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

Renal Calculi

Urinary Calculi

Study ID

NCT03811171

Start date

Aug 20, 2019

Status verified date

Jul, 2025

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Jan 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

70 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment

The arm receives the investigational Break Wave procedure.

Interventions

Break Wave extracorporeal lithotripsy

The 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.

Primary outcome measure

  • Primary Effectiveness Outcome - Stone Fragmentation [ Time Frame: 12 weeks post-treatment ]
  • Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia [ Time Frame: 12 weeks post-treatment ]

Central Contacts and Locations

Central contacts

Oren Levy, PhD

4156722631oren.levy@sonomotion.com

Locations

Vancouver General Hospital Stone Centre

Recruiting

Vancouver, British Columbia, Canada, BC V5Z 1M9

More Information

Sponsor

SonoMotion

Last update posted

Jul 29, 2025

Last verified

Jul, 2025

Keywords

  • Stone
  • Lithotripsy
  • Calculi

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by SonoMotion on 2025-07-29.