Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study

July 24, 2025 updated by: SonoMotion

A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G1Z1
        • Completed
        • University of Alberta, Division of Urology
    • British Columbia
      • Vancouver, British Columbia, Canada, BC V5Z 1M9
        • Recruiting
        • Vancouver General Hospital Stone Centre
        • Contact:
          • Ben Chew
    • Ontario
  • United States
    • California
      • San Diego, California, United States, 92103
        • Completed
        • University of California San Diego Health
      • San Francisco, California, United States, 94143
        • Completed
        • University of California, San Francisco
    • Washington
      • Seattle, Washington, United States, 98195
        • Completed
        • University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
The arm receives the investigational Break Wave procedure.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Effectiveness Outcome - Stone Fragmentation
Time Frame: 12 weeks post-treatment
Stone fragmentation as determined by stone passage or imaging confirmation.
12 weeks post-treatment
Primary Safety Outcome - Hematoma, urinary tract sepsis, or cardiac arrythmia
Time Frame: 12 weeks post-treatment
The documented occurrence of clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrythmia.
12 weeks post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary effectiveness outcome - Stone Free Status
Time Frame: 12 weeks post-treatment
Radiographic evidence (CT imaging) of stone free status.
12 weeks post-treatment
Secondary effectiveness outcome - Residual fragment size
Time Frame: 12 weeks post-treatment
Presence of only stone fragments small enough to pass (less than or equal to 4 mm).
12 weeks post-treatment
Secondary safety outcome - Adverse events
Time Frame: 12 weeks post-treatment
documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events associated with shock wave lithotripsy (SWL)
12 weeks post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SonoMotion

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2019

Primary Completion (Estimated)

January 30, 2027

Study Completion (Estimated)

March 30, 2027

Study Registration Dates

First Submitted

January 17, 2019

First Submitted That Met QC Criteria

January 18, 2019

First Posted (Actual)

January 22, 2019

Study Record Updates

Last Update Posted (Actual)

July 29, 2025

Last Update Submitted That Met QC Criteria

July 24, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-0001
  • R44DK109779 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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