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

Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones

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.

Study Overview

• Status: Completed
• Conditions: Kidney Calculi; Nephrolithiasis; Urinary Calculi; Urolithiasis; Renal Calculi; Kidney Stone; Nephrolith
• Intervention / Treatment: Device: Break Wave extracorporeal lithotripsy

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z1
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada
      • University of British Columbia
  • Ontario
    • Toronto, Ontario, Canada, M5C 2T2
      • St. Michael's Hospital, University of Toronto
• United States
  • California
    • San Diego, California, United States, 92037
      • University of California- San Diego
    • San Francisco, California, United States, 94143
      • University of California - San Francisco
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Medicine
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Lehigh Valley Health Network
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Effectiveness Endpoint	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).	10 +/- 2 weeks post final Break Wave procedure
Primary Safety Endpoint	Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia	During procedure and through 90 days post-procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: SonoMotion
• Investigators: Study Director: Mathew D. Sorensen, M.D., University of Washington Medicine

Publications and helpful links

General Publications

• Chew BH, Harper JD, Sur RL, Chi T, De S, Buckley AR, Paterson RF, Wong VKF, Forbes CM, Hall MK, Kessler R, Bechis SK, Woo JR, Wang RC, Bayne DB, Bochinski D, Schuler TD, Wollin TA, Samji R, Sorensen MD. Break Wave Lithotripsy for Urolithiasis: Results of the First-in-Human International Multi-Institutional Clinical Trial. J Urol. 2024 Oct;212(4):580-589. doi: 10.1097/JU.0000000000004091. Epub 2024 Sep 10.

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2023
• Primary Completion (Actual): June 18, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 24, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Urolithiasis; Non-invasive; Nephrolithiasis; Urinary Calculi; Extracorporeal; Renal Calculi; Ultrasound therapy; Kidney Stone; Kidney Calculi; Nephrolith
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pathological Conditions, Signs and Symptoms; Kidney Calculi; Nephrolithiasis; Urinary Calculi; Urolithiasis
• Other Study ID Numbers: CP0002

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