SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)

Not Applicable

Recruiting

• Conditions: Kidney Stone; Kidney Calculi; Nephrolithiasis; Nephrolith; Renal Calculi; Urinary Calculi; Urolithiasis
• Interventions: Device: Break Wave extracorporeal lithotripsy

• Registration Number: NCT05701098
• Lead Sponsor: SonoMotion

Brief 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.

Study Timeline

• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-01-27
• Study Start: 2023-10-09
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-28
• Primary Completion: 2024-12
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 116

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Break Wave™ Procedure	Break Wave extracorporeal lithotripsy	The subject will undergo the Break Wave procedure.

Primary Outcome Measures

Name	Time	Method
Primary Effectiveness Endpoint	10 +/- 2 weeks post final Break Wave procedure	Proportion of subjects with a radiographic assessment of the target stone demonstrating either (i) stone free status (zero fragments) or (ii) the presence of only stone fragments small enough to pass spontaneously (≤ 4 mm).
Primary Safety Endpoint	During procedure and through 90 days post-procedure	Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia

Secondary Outcome Measures

Name	Time	Method
Secondary safety endpoint	During procedure and through 90 days post-procedure	Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs)

Trial Locations

Locations (10)

University of California- San Diego; 🇺🇸 San Diego, California, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Northwestern Medicine; 🇺🇸 Chicago, Illinois, United States

St. Michael's Hospital, University of Toronto; 🇨🇦 Toronto, Ontario, Canada

Kaiser Permanente; 🇺🇸 Santa Clara, California, United States

Lehigh Valley Health Network; 🇺🇸 Allentown, Pennsylvania, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Washington; 🇺🇸 Seattle, Washington, United States

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

University of California - San Francisco; 🇺🇸 San Francisco, California, United States