SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

Completed · Not applicable

Conditions studied: Kidney Stone, Urolithiasis, Nephrolithiasis, Renal Calculi, Kidney Calculi, Nephrolith, Urinary Calculi

In brief

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.

Key facts

Study ID: NCT05701098
Run by: SonoMotion
People needed: 64
Starts: 2023-10-09
Expected to finish: 2025-07-31
Last updated by the study team: 2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

Subject has an acute untreated urinary tract infection or urosepsis.
Subject has an uncorrected bleeding disorder or coagulation abnormality.
Subject is confirmed to be or suspected to be pregnant.
Subject has a urinary tract obstruction distal to the stone.
Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
Subject has stones that are not echogenically visible with ultrasound.
Subject belongs to a vulnerable group (prisoner, etc.).
Patients unwilling to comply with the follow-up protocol, including post-procedure radiographic imaging.
Subject is under 18 years of age.
Subject's anatomy limits ability to focus on or deliver Break Wave to the target stone (e.g. viable acoustic window).
Subject has a calcified abdominal aortic aneurysm or calcified renal artery aneurysms.
Subject has a solitary kidney.
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.
Subject is unable to read or comprehend the consent form.

Where it is running

University of California- San Diego — San Diego, California, United States
University of California - San Francisco — San Francisco, California, United States
Kaiser Permanente — Santa Clara, California, United States
Northwestern Medicine — Chicago, Illinois, United States
Lehigh Valley Health Network — Allentown, Pennsylvania, United States
Vanderbilt University — Nashville, Tennessee, United States
University of Washington — Seattle, Washington, United States
University of Alberta — Edmonton, Alberta, Canada
University of British Columbia — Vancouver, British Columbia, Canada
St. Michael's Hospital, University of Toronto — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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