Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT03873259

Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Led by University of Washington · Updated on 2026-05-13

40

Participants Needed

2

Research Sites

455 weeks

Total Duration

On this page

Sponsors

U

University of Washington

Lead Sponsor

I

Indiana University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals presenting with at least one kidney stone visible on CT
  • Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Not Eligible

You will not qualify if you...

  • 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 comorbidity risks judged by a physician to make them a poor candidate for BWL

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

IU Health North Hospital

Carmel, Indiana, United States, 46032

Actively Recruiting

2

University of Washington Medical Center

Seattle, Washington, United States, 98195

Actively Recruiting

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Research Team

M

Michael R Bailey, PhD, MS

CONTACT

B

Barbrina Dunmire

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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