SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD)
United States64 participantsStarted 2023-10-09
Plain-language summary
The goal of this clinical trial is to test the Break Waveâ„¢ 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 Waveâ„¢ procedure, b) have a telehealth visit at 2 weeks, and c) return for an imaging study at approximately 10 weeks post-procedure.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects presenting with at least one stone apparent on radiographic imaging.
✓. Target stone must be within the upper urinary tract.
✓. Target stone is indicated for shock wave lithotripsy (SWL) treatment per American Urological Association (AUA) 2016 guidelines.
✓. Target stone size is \> 4 mm and ≤ 10 mm.
✓. Subject is willing and able to provide informed consent and comply with the study protocol required follow up visits.
✓. Target stone can be individually visualized from other stones.
Exclusion criteria
✕. Subject has an acute untreated urinary tract infection or urosepsis.
✕. Subject has an uncorrected bleeding disorder or coagulation abnormality.
✕. Subject is confirmed to be or suspected to be pregnant.
✕. Subject has a urinary tract obstruction distal to the stone.
✕. Subject is receiving anticoagulants and is unable or not willing to cease the medication for the Break Wave procedure
✕. Subject has stones that are not echogenically visible with ultrasound.
✕. Subject belongs to a vulnerable group (prisoner, etc.).
What they're measuring
1
Primary Effectiveness Endpoint
Timeframe: 10 +/- 2 weeks post final Break Wave procedure
2
Primary Safety Endpoint
Timeframe: During procedure and through 90 days post-procedure