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SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) (SOUND)

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. Identifier: NCT05701098
Recruitment Status : Recruiting
First Posted : January 27, 2023
Last Update Posted : February 28, 2024
Information provided by (Responsible Party):

Brief Summary:

The goal of this clinical trial is to test the Break Wave™ system in patients with upper urinary tract stones. The main question it aims to answer is whether the device is safe and effective in fragmenting (breaking) stones.

Participants will a) undergo the Break Wave™ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.

Condition or disease Intervention/treatment Phase
Kidney Stone Urolithiasis Nephrolithiasis Renal Calculi Kidney Calculi Nephrolith Urinary Calculi Device: Break Wave extracorporeal lithotripsy Not Applicable

Detailed Description:

This is a prospective, open-label, multi-center, single-arm (non-randomized) study to demonstrate the safety and effectiveness of breaking stones in the upper urinary tract using the SonoMotion Break Wave™ technology. Up to 116 patients will be screened to participate. Depending on the institution, the procedure may be performed in an outpatient hospital surgical environment, or in a non-surgical environment such as a clinic or office procedure room. Subjects will have a target stone diagnosed to be >4millimeter (mm) to 10 mm in size.

Safety will be measured by the adverse event occurrence, unplanned emergency department or clinic visits, and the need for further intervention. Effectiveness will be determined by the size of fragments identified at the 10 week follow-up imaging.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
Actual Study Start Date : October 9, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Break Wave™ Procedure
The subject will undergo the 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 ultrasound imaging system and a therapy probe driven by a high voltage generator. The probe will be placed on the patient's skin, the stone located via diagnostic ultrasound and up to 30 minutes of therapy will be delivered to the stone. The therapy probe accommodates coaxial alignment of an ultrasound imaging probe for treatment guidance.

Primary Outcome Measures :
  1. Primary Effectiveness Endpoint [ Time Frame: 10 +/- 2 weeks post final Break Wave procedure ]
    Proportion of subjects with a radiographic assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (≤ 4 mm).

  2. Primary Safety Endpoint [ Time Frame: During procedure and through 90 days post-procedure ]
    Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia

Secondary Outcome Measures :
  1. Secondary safety endpoint [ Time Frame: During procedure and through 90 days post-procedure ]
    Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs)

Information from the National Library of Medicine

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.

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

Inclusion Criteria:

  1. Subjects presenting with at least one stone apparent on radiographic imaging.
  2. Target stone must be within the upper urinary tract.
  3. Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
  4. Target stone size is > 4 mm and ≤ 10 mm.
  5. Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
  6. Target stone can be individually visualized from other stones.

Exclusion Criteria:

  1. Subject has an acute untreated urinary tract infection or urosepsis.
  2. Subject has an uncorrected bleeding disorder or coagulation abnormality.
  3. Subject is confirmed to be or suspected to be pregnant.
  4. Subject has a urinary tract obstruction distal to the stone.
  5. Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
  6. Subject has stones that are not echogenically visible with ultrasound.
  7. Subject belongs to a vulnerable group (prisoner, etc.).
  8. Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
  9. Subject is under 18 years of age.
  10. Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
  11. Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
  12. Subject has a solitary kidney.
  13. Subject has a comorbidity risk(s) which, at the discretion of the physician, would make the subject a poor candidate for the Break Wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.
  14. Subject is unable to read or comprehend the consent form.

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 identifier (NCT number): NCT05701098

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Contact: Emily Hergenreter 9255949600

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United States, California
University of California- San Diego Recruiting
San Diego, California, United States, 92037
Contact: Jamie Finegan   
Principal Investigator: Roger Sur, MD         
University of California - San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Michelle Li   
Contact: Victoria Hogue   
Principal Investigator: Justin Ahn, MD         
Sub-Investigator: Ralph Wang, MD         
Kaiser Permanente Recruiting
Santa Clara, California, United States, 95051
Contact: Yasha Rezaeihaghighi, RN   
Principal Investigator: Helena Chang, MD         
Sub-Investigator: Leo Chen, MD         
United States, Illinois
Northwestern Medicine Recruiting
Chicago, Illinois, United States, 60611
Contact: Alyssa McDonald   
Principal Investigator: Amy E. Krambeck, MD         
Sub-Investigator: Madhvi Deol, MD         
Sub-Investigator: Nicholas Dean, MD         
Sub-Investigator: Amanda Vo, MD         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Samuel Rivera   
Principal Investigator: James R. Johannes, MD         
Sub-Investigator: Errin J. Hoffman, MD         
United States, Tennessee
Vanderbilt University Not yet recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Nicholas Kavoussi, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Barbara H Burke   
Principal Investigator: Jonathan D. Harper, MD         
Sub-Investigator: M. Kennedy Hall, MD         
Sub-Investigator: Mathew D. Sorensen, MD         
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z1
Contact: Ijeoma Ogbuehi, PhD   
Principal Investigator: Shubha K. De, MD         
Sub-Investigator: Rahim Samji, MD         
Sub-Investigator: Tim A Wollin, MD         
Sub-Investigator: Trevor Schuler, MD         
Sub-Investigator: Richard Bochinski, MD         
Canada, British Columbia
University of British Columbia Recruiting
Vancouver, British Columbia, Canada
Contact: Victor Wong   
Principal Investigator: Ben Chew, MD         
Sub-Investigator: Connor Forbes, MD         
Sub-Investigator: Ryan Patterson, MD         
Canada, Ontario
St. Michael's Hospital, University of Toronto Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Contact: Daniela Ghiculete, MD MSc   
Principal Investigator: Kenneth Pace, MD Msc FRCSC         
Sponsors and Collaborators
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Responsible Party: SonoMotion Identifier: NCT05701098    
Other Study ID Numbers: CP0002
First Posted: January 27, 2023    Key Record Dates
Last Update Posted: February 28, 2024
Last Verified: February 2024
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
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by SonoMotion:
Kidney Stone
Renal Calculi
Kidney Calculi
Urinary Calculi
Ultrasound therapy
Additional relevant MeSH terms:
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Kidney Calculi
Urinary Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases