Evaluating Burst Wave Lithotripsy for Breaking Up Kidney and Ureter Stones During Surgery A Safety and Effectiveness Study in Adults

What this Trial Is About

Researchers are evaluating a new device called Burst Wave Lithotripsy BWL for breaking up urinary tract stones. BWL uses low amplitude ultrasound bursts to fragment stones, differing from traditional shock wave lithotripsy which uses high amplitude shock waves. This single-arm feasibility study aims to test how well BWL can fragment stones in humans during surgery. Participants will receive BWL treatment in the operating room just before their standard ureteroscopic laser lithotripsy procedure. The treatment involves delivering ultrasound bursts at specific settings 350 kHz frequency, 7 MPa peak negative pressure, 20 cycle pulse duration, 17 Hz repetition for up to 10 minutes per stone. Up to three stones per participant can be treated. The study is conducted at two centers in the US. During the procedure, researchers will monitor safety by visually inspecting tissue with a ureteroscopic camera and tracking any adverse events or unplanned medical visits. Effectiveness will be measured by observing stone fragmentation visually and by measuring stone fragments removed after surgery. Safety assessments continue for up to 120 days after treatment. Participation lasts through the surgery and includes post-procedure monitoring.

Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)