Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)

May 10, 2026 updated by: Jonathan Harper, MD, University of Washington

Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a two-center, single-arm, feasibility study. The two centers are located within the US and include: University of Washington (UW) School of Medicine and Indiana University (IU) Health Urology Clinic.

The investigative study will be performed in the operating room prior to a standard-of-care (SoC) ureteroscopic (URS) laser lithotripsy procedure. The subject will already be under anesthesia. Stones will be limited to ≤ 12 mm.

The study has one (treatment) arm and is approved to enroll up to 40 subjects (with the intent to treat 20 subjects). All subjects will be treated with the same output parameters for up to a maximum of 10 minutes per stone. The output parameters are nominally defined as:

  • 350 kil0Hertz (kHz) acoustic frequency
  • 7 MegaPascals (MPa) peak negative pressure
  • 20 cycle pulse duration
  • 17 Hz pulse repetition frequency

A maximum of 3 stones can be treated per subject.

Safety will be monitored by visual observation of the tissue with an ureteroscopic camera, the self-reported occurrences of adverse events, and occurrences of unplanned emergency department or clinic visits. Fragmentation will be measured by visual observation with an ureteroscopic camera and direct measure of stones removed by basket after the procedure.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Michael R Bailey, PhD, MS
  • Phone Number: 206-619-2035
  • Email: mbailey@uw.edu

Study Contact Backup

  • Name: Barbrina Dunmire
  • Phone Number: 206-769-5910
  • Email: mrbean@uw.edu

Study Locations

  • United States
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • IU Health North Hospital
        • Contact:
          • Kimberly Smoot
    • Washington
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center
        • Contact:
          • Barbara Burke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.
Device: Burst Wave Lithotripsy
Fragment upper urinary tract stones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Area of Tissue Injury
Time Frame: Day 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.
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.
The primary effectiveness endpoint is the volume fraction of stone fragments less than 2 mm relative to the original stone volume.
Day 0 - the day of the experimental procedure immediately following the acoustic procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety - Adverse Event Assessment
Time Frame: out to 120 days post-procedure
The secondary safety outcome is the documented occurrence of all adverse events and comparison of the incidence (rate of occurrence) to the adverse events typically associated with shock wave lithotripsy (SWL) and URS
out to 120 days post-procedure
Effectiveness - Time to Full Comminution
Time Frame: Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm
Day 0 - the day of the experimental procedure immediately following the acoustic procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Indiana University

Investigators

  • Principal Investigator: Michael R Bailey, PhD, MS, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2019

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

April 30, 2028

Study Registration Dates

First Submitted

March 9, 2019

First Submitted That Met QC Criteria

March 11, 2019

First Posted (Actual)

March 13, 2019

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 10, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SITE00000349
  • 5P01DK043881-22 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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