Extracorporeal Lithotripsy for Kidney Stones

(SOUND Trial)

Recruiting at 9 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: SonoMotion

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing the Break Wave™ system, which uses sound waves to break up kidney stones. It targets patients with stones between 4mm and 10mm in size. The goal is to see if the device is safe and effective in making the stones small enough to pass naturally. The Break Wave™ system is a new method of lithotripsy that uses short, broadly focused bursts of ultrasound rather than shock waves to fragment stones.

Research Team

Mathew D. Sorensen, M.D.

Principal Investigator

University of Washington Medicine

Eligibility Criteria

This trial is for adults with kidney stones larger than 4mm but smaller or equal to 10mm, located in the upper urinary tract and suitable for shock wave treatment. Participants must be able to give informed consent, follow the study protocol, and attend follow-up visits. Excluded are those under 18, pregnant women, patients on anticoagulants who can't stop them temporarily, individuals with certain aneurysms or solitary kidneys, those unable to understand the consent form, anyone with untreated UTIs or urosepsis, prisoners or vulnerable groups.

Inclusion Criteria

The size of the target stone is bigger than 4 millimeters and smaller than or equal to 10 millimeters.

The stone that needs to be treated can be clearly seen and distinguished from other stones.

My kidney stone is suitable for shock wave treatment according to 2016 guidelines.

Exclusion Criteria

I currently have an untreated urinary tract infection or urosepsis.

Your kidney stones cannot be seen clearly on an ultrasound.

I am willing to follow all follow-up care instructions, including getting imaging tests.

Treatment Details

Interventions

• Break Wave (Extracorporeal Shock Wave Lithotripsy)

Trial Overview The SOUND Pivotal Trial tests the Break Wave™ system's safety and effectiveness in breaking up kidney stones using extracorporeal lithotripsy. Patients will undergo one procedure followed by a telehealth check-in at two weeks and an imaging study around ten weeks later to assess stone fragmentation.

Participant Groups

Group I: Break Wave™ Procedure Experimental Treatment 1 Intervention

The subject will undergo the Break Wave procedure.

Who Is Running the Clinical Trial?

SonoMotion

Lead Sponsor

Trials

2

Recruited

150+