Burst wave lithotripsy used during ureteroscopy to break kidney or ureter stones
Official title: Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness
Run by University of Washington · NCT03873259 · Data updated 2026-11-12
This study tests a new ultrasound method called burst wave lithotripsy to try to break kidney or ureter stones during ureteroscopy in adults scheduled for stone removal.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Washington Academic / other |
| Locations | 2 sites (Carmel, Indiana and 1 other locations) |
| Status | Recruiting |
| Started | August 8, 2019 |
| Main results expected | December 31, 2027 |
| Study ends | April 30, 2028 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT03873259 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with at least one kidney or ureter stone visible on CT who are already scheduled for ureteroscopic stone removal and who do not have excluded comorbidities are the intended participants.
✕Probably not a fit
Patients with stones larger than 12 mm, a solitary kidney, uncorrected bleeding disorders, significant anticoagulation, calcified aortic or renal artery aneurysms, pregnant people, minors, or other physician-deemed high-risk comorbidities are excluded and unlikely to benefit from this procedure.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
At two U.S. academic centers, this single-arm feasibility protocol will enroll adults undergoing standard ureteroscopic stone removal and apply burst wave lithotripsy (BWL) intraoperatively while the patient is under anesthesia. Stones up to 12 mm will be treated for up to 10 minutes per stone using fixed ultrasound settings (350 kHz, ~7 MPa peak negative pressure, 20-cycle pulses at 17 Hz), with up to three stones treated per subject. Fragmentation will be measured visually with the ureteroscope and by collecting fragments with a basket, while safety is monitored by endoscopic observation, adverse event reporting, and tracking unplanned clinic or ED visits. The purpose is to gather initial human feasibility and safety data on whether BWL can comminute stones during ureteroscopy.
Why it matters
Potential benefit: If successful, BWL could fragment stones more quickly and with less collateral tissue trauma during ureteroscopy, potentially reducing laser use and procedure time.
How similar studies have gone: BWL is a relatively new approach with encouraging preclinical work and early feasibility reports but has not yet been widely proven in larger clinical trials.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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IU Health North Hospital
Carmel, Indiana, United States Recruiting -
University of Washington Medical Center
Seattle, Washington, United States Recruiting
Study contacts
- Principal investigator: Michael R Bailey, PhD, MS — University of Washington
- Study coordinator: Michael R Bailey, PhD, MS
- Email: mbailey@uw.edu
- Phone: 206-619-2035
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.