Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness
University of Washington
40 participants
Aug 8, 2019
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria2
- Individuals presenting with at least one kidney stone apparent on CT
- Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Exclusion Criteria7
- 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
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Interventions
Fragment upper urinary tract stones
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT03873259