Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.
This is a two-center, single-arm, feasibility study. The two centers are located within the US and include: University of Washington (UW) School of Medicine and Indiana University (IU) Health Urology Clinic. The investigative study will be performed in the operating room prior to a standard-of-care (SoC) ureteroscopic (URS) laser lithotripsy procedure. The subject will already be under anesthesia. Stones will be limited to ≤ 12 mm. The study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 20 subjects). All subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. The output parameters are nominally defined as: * 350 kil0Hertz (kHz) acoustic frequency * 7 MegaPascals (MPa) peak negative pressure * 20 cycle pulse duration * 17 Hz pulse repetition frequency A maximum of 3 stones can be treated per subject. Safety will be monitored by visual observation of the tissue with an ureteroscopic camera, the self-reported occurrences of adverse events, and occurrences of unplanned emergency department or clinic visits. Fragmentation will be measured by visual observation with an ureteroscopic camera and direct measure of stones removed by basket after the procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Fragment upper urinary tract stones
IU Health North Hospital
Carmel, Indiana, United States
University of Washington Medical Center
Seattle, Washington, United States
Safety - Area of Tissue Injury
The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.
Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Effectiveness - Volume of Fragments < 2 mm
The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.
Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Safety - Adverse Event Assessment
The secondary safety outcome is the documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events typically associated with shock wave lithotripsy (SWL) and URS
Time frame: out to 120 days post-procedure
Effectiveness - Time to Full Comminution
projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm
Time frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
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