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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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
About the study
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.
What is being tested
- Burst Wave Lithotripsy (device)
Sponsor: University of Washington · Participants: 40 · Started: Aug 8, 2019
Contact the study team
- Michael R Bailey, PhD, MS · Phone: 206-619-2035
- Barbrina Dunmire · Phone: 206-769-5910
Official record on ClinicalTrials.gov — NCT03873259
Locations in the U.S.
| Indiana | IU Health North Hospital, Carmel |
| Washington | University of Washington Medical Center, Seattle |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.