NCT05701098

SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: SonoMotion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-10-09
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2023-01-27
• Last updated: 2025-05-30

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated device study