Recruiting

Burst Wave LithotripsyIntraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Sponsor:

University of Washington

Code:

NCT03873259

Conditions

Renal Calculi

Ureteral Calculi

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Burst Wave Lithotripsy

Study Details

Brief 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.

Conditions

Renal Calculi

Ureteral Calculi

Study ID

NCT03873259

Start date

Aug 8, 2019

Status verified date

Jul, 2026

Completion date

Apr 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment Group

Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.

Interventions

Burst Wave Lithotripsy

Fragment upper urinary tract stones

Primary outcome measure

Safety - Area of Tissue Injury [ Time Frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure. ]
Effectiveness - Volume of Fragments < 2 mm [ Time Frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure. ]

Central Contacts and Locations

Central contacts

Michael R Bailey, PhD, MS

206-619-2035 mbailey@uw.edu

Barbrina Dunmire

206-769-5910 mrbean@uw.edu

Locations

IU Health North Hospital

Recruiting

Carmel, Indiana, United States, 46032

University of Washington Medical Center

Recruiting

Seattle, Washington, United States, 98195

More Information

Sponsor

University of Washington

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-07-21.