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NCT Number: NCT03811171

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

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.

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Key information

Conditions

Renal Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Calculi Kidney Diseases Male Urogenital Diseases Nephrolithiasis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta, Division of Urology, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Break Wave extracorporeal lithotripsy

Device

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 outcomes

  1. Primary Effectiveness Outcome - Stone Fragmentation

    Time frame: 12 weeks post-treatment

    Stone fragmentation as determined by stone passage or imaging confirmation.

  2. 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 outcomes

  1. Secondary effectiveness outcome - Stone Free Status

    Time frame: 12 weeks post-treatment

    Radiographic evidence (CT imaging) of stone free status.

  2. 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).

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Oren Levy, PhD

CONTACT

[email protected]

4156722631

Sponsors and collaborators

Lead sponsor

SonoMotion

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2019
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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