SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

Description

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.

Conditions

Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith, Urinary Calculi

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Study Overview

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Study Details

Study overview

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.

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

SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

Condition
Kidney Stone
Intervention / Treatment

-

Contacts and Locations

San Diego

University of California- San Diego, San Diego, California, United States, 92037

San Francisco

University of California - San Francisco, San Francisco, California, United States, 94143

Santa Clara

Kaiser Permanente, Santa Clara, California, United States, 95051

Chicago

Northwestern Medicine, Chicago, Illinois, United States, 60611

Allentown

Lehigh Valley Health Network, Allentown, Pennsylvania, United States, 18103

Nashville

Vanderbilt University, Nashville, Tennessee, United States, 37232

Seattle

University of Washington, Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

SonoMotion,

Study Record Dates

2026-01