Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
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About
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.
Full description
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.
Enrollment
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Volunteers
Inclusion criteria
- Individuals presenting with at least one kidney stone apparent on CT
- Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Exclusion criteria
- Individuals under 18 years of age
- Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.)
- Individuals with uncorrected bleeding disorders or coagulopathies
- Individuals taking a clinically significant anticoagulant dose at the time of the procedure
- Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm
- Individuals with a solitary kidney
- Individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the BWL procedure
Trial design
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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