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

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ClinicalTrials.gov Identifier: NCT03811171
Recruitment Status : Recruiting
First Posted : January 22, 2019
Last Update Posted : March 18, 2021
Sponsor:
Information provided by (Responsible Party):
SonoMotion

Study Description
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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.


Condition or disease Intervention/treatment Phase
Renal Calculi Urinary Calculi Device: Break Wave extracorporeal lithotripsy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Intervention Details:
  • 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.

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Oren Levy, PhD 4156722631 oren.levy@sonomotion.com

Locations
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United States, California
University of California San Diego Health Recruiting
San Diego, California, United States, 92103
Contact: Roger Sur         
United States, Washington
University of Washington Medical Center Recruiting
Seattle, Washington, United States, 98195
Contact: Barb Burke         
Canada, British Columbia
Vancouver General Hospital Stone Centre Recruiting
Vancouver, British Columbia, Canada, BC V5Z 1M9
Contact: Ben Chew         
Sponsors and Collaborators
SonoMotion
More Information
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Additional Information:

Publications:

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Responsible Party: SonoMotion
ClinicalTrials.gov Identifier: NCT03811171    
Other Study ID Numbers: CLP-0001
First Posted: January 22, 2019    Key Record Dates
Last Update Posted: March 18, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by SonoMotion:
Stone
Lithotripsy
Calculi
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Urinary Calculi
Urolithiasis
 Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases