Break Wave(TM) Extracorporeal Lithotripter First-in-Human Study
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03811171 |
Recruitment Status :
Recruiting
First Posted : January 22, 2019
Last Update Posted : May 19, 2022
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Renal Calculi Urinary Calculi | Device: Break Wave extracorporeal lithotripsy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Study of the SonoMotion Break Wave(TM) System for the Comminution of Urinary Tract Stones |
Actual Study Start Date : | August 20, 2019 |
Estimated Primary Completion Date : | February 28, 2023 |
Estimated Study Completion Date : | June 30, 2023 |

Arm | Intervention/treatment |
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Experimental: Treatment
The arm receives the investigational Break Wave procedure.
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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. |
- Primary Effectiveness Outcome - Stone Fragmentation [ Time Frame: 12 weeks post-treatment ]Stone fragmentation as determined by stone passage or imaging confirmation.
- 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.
- Secondary effectiveness outcome - Stone Free Status [ Time Frame: 12 weeks post-treatment ]Radiographic evidence (CT imaging) of stone free status.
- 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).
- 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)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03811171
Contact: Oren Levy, PhD | 4156722631 | oren.levy@sonomotion.com |
United States, California | |
University of California San Diego Health | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Roger Sur | |
University of California, San Francisco | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Thomas Chi, MD 415-353-2200 tom.chi@ucsf.edu | |
Contact: Ralph Wang, MD 415-353-1634 ralph.wang@ucsf.edu | |
United States, Washington | |
University of Washington Medical Center | Recruiting |
Seattle, Washington, United States, 98195 | |
Contact: Barb Burke | |
Canada, Alberta | |
University of Alberta, Division of Urology | Recruiting |
Edmonton, Alberta, Canada, T6G1Z1 | |
Contact: Shuba De, MD 780-407-5800 shubha1@ualberta.ca | |
Contact: Breanne Stewart, RN 780-974-8606 breanne1@ualberta.ca | |
Canada, British Columbia | |
Vancouver General Hospital Stone Centre | Recruiting |
Vancouver, British Columbia, Canada, BC V5Z 1M9 | |
Contact: Ben Chew | |
Canada, Ontario | |
St. Michael's Unity Health Toronto | Not yet recruiting |
Toronto, Ontario, Canada, M5C 2T2 | |
Contact: Kenneth Pace, MD 416-867-3695 Kenneth.Pace@unityhealth.to | |
Contact: Daniela Ghiculete, MSc 416-864-6060 Daniela.Ghiculete@unityhealth.to |
Publications:
Responsible Party: | SonoMotion |
ClinicalTrials.gov Identifier: | NCT03811171 |
Other Study ID Numbers: |
CLP-0001 |
First Posted: | January 22, 2019 Key Record Dates |
Last Update Posted: | May 19, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Stone Lithotripsy Calculi |
Kidney Calculi Nephrolithiasis Urinary Calculi Urolithiasis |
Calculi Pathological Conditions, Anatomical Kidney Diseases Urologic Diseases |