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

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.

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.

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.