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Intraoperative Assessment of Burst Wave Lithotripsy (BWL) for Kidney and Ureteral Stones

This study is testing a new way to break up kidney and ureteral stones called Burst Wave Lithotripsy (BWL). Unlike traditional methods, BWL uses gentle, multi-cycle ultrasound bursts to fragment stones. This study aims to see if BWL can effectively break up stones in people and how safe it is. Researchers will measure the area of tissue injury and the volume of stone fragments smaller than 2mm. You can join if you are 18 or older, have at least one kidney stone visible on a CT scan, and are already scheduled for a standard stone removal procedure (ureteroscopy). The study is currently unclear on its recruitment status and plans to enroll up to 40 participants.

Study design
This is a single-arm feasibility study, meaning all participants will receive the same treatment. It aims to enroll up to 40 people.
What's involved
You would receive the BWL procedure in the operating room while already under anesthesia, just before your standard stone removal surgery. This procedure will last up to 10 minutes per stone.
Compensation
Not stated in the trial record.
Follow-up
Safety and effectiveness will be measured immediately after the procedure on Day 0.

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NCT03873259

Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Recruiting
NAAges 18+InterventionalTreatment
University of Washington
~40 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Burst Wave Lithotripsy

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety - Area of Tissue Injury
Measured over Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
+1 more outcome measured

Conditions

Renal Calculi
Ureteral Calculi

Explore related trials

NephrolithiasisUreteric Stone

Where it's being run

2 sites across 2 states
Indiana1
Washington1

Study leadership

  • Michael R Bailey, PhD, MS · PRINCIPAL_INVESTIGATOR · University of Washington

Who to contact

Michael R Bailey, PhD, MS
[email protected]
206-619-2035
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Eligibility criteria

Inclusion

Individuals presenting with at least one kidney stone apparent on CT
Individuals scheduled for clinical stone removal via ureteroscopy (URS)

Exclusion

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

What this trial measures

  • Safety - Area of Tissue InjuryDay 0 - the day of the experimental procedure immediately following the acoustic procedure.

    The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.

  • Effectiveness - Volume of Fragments < 2 mmDay 0 - the day of the experimental procedure immediately following the acoustic procedure.

    The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.