Urolithiasis Clinical Trial
— SOUNDOfficial title:
Pivotal Study of the SonoMotion Break Wave™ (Trade Mark) System for the Comminution of Urinary Tract Stones
NCT number | NCT05701098 |
Other study ID # | CP0002 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | October 9, 2023 |
Est. completion date | January 2025 |
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.
Status | Recruiting |
Enrollment | 116 |
Est. completion date | January 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
Canada | St. Michael's Hospital, University of Toronto | Toronto | Ontario |
Canada | University of British Columbia | Vancouver | British Columbia |
United States | Lehigh Valley Health Network | Allentown | Pennsylvania |
United States | Northwestern Medicine | Chicago | Illinois |
United States | Vanderbilt University | Nashville | Tennessee |
United States | 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 | University of Washington | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
SonoMotion |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary Effectiveness Endpoint | 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). | 10 +/- 2 weeks post final Break Wave procedure | |
Primary | Primary Safety Endpoint | Occurrence of device and procedure related clinically significant or symptomatic hematoma (perirenal/intrarenal), urinary tract sepsis, or serious cardiac arrhythmia | During procedure and through 90 days post-procedure | |
Secondary | Secondary safety endpoint | Occurrence of all device and procedure related adverse events (AEs), including serious adverse events (SAEs), and Unanticipated Adverse Device Effects (UADEs) | During procedure and through 90 days post-procedure |
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