Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness
2 other identifiers
interventional
40
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 9, 2019
CompletedFirst Posted
Study publicly available on registry
March 13, 2019
CompletedStudy Start
First participant enrolled
August 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedJuly 10, 2025
May 1, 2025
6.4 years
March 9, 2019
July 7, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Safety - Area of Tissue Injury
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
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 Outcomes (2)
Safety - Adverse Event Assessment
out to 120 days post-procedure
Effectiveness - Time to Full Comminution
Day 0 - the day of the experimental procedure immediately following the acoustic procedure.
Study Arms (1)
Treatment Group
EXPERIMENTALSubjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.
Interventions
Eligibility Criteria
You may qualify if:
- Individuals presenting with at least one kidney stone apparent on CT
- Individuals scheduled for clinical stone removal via ureteroscopy (URS)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
IU Health North Hospital
Carmel, Indiana, 46032, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
Related Publications (4)
May PC, Kreider W, Maxwell AD, Wang YN, Cunitz BW, Blomgren PM, Johnson CD, Park JSH, Bailey MR, Lee D, Harper JD, Sorensen MD. Detection and Evaluation of Renal Injury in Burst Wave Lithotripsy Using Ultrasound and Magnetic Resonance Imaging. J Endourol. 2017 Aug;31(8):786-792. doi: 10.1089/end.2017.0202. Epub 2017 Jun 16.
PMID: 28521550BACKGROUNDMaxwell AD, Cunitz BW, Kreider W, Sapozhnikov OA, Hsi RS, Harper JD, Bailey MR, Sorensen MD. Fragmentation of urinary calculi in vitro by burst wave lithotripsy. J Urol. 2015 Jan;193(1):338-44. doi: 10.1016/j.juro.2014.08.009. Epub 2014 Aug 9.
PMID: 25111910BACKGROUNDBailey MR, Maxwell AD, Cao S, Ramesh S, Liu Z, Williams JC, Thiel J, Dunmire B, Colonius T, Kuznetsova E, Kreider W, Sorensen MD, Lingeman JE, Sapozhnikov OA. Improving Burst Wave Lithotripsy Effectiveness for Small Stones and Fragments by Increasing Frequency: Theoretical Modeling and Ex Vivo Study. J Endourol. 2022 Jul;36(7):996-1003. doi: 10.1089/end.2021.0714. Epub 2022 Jun 22.
PMID: 35229652DERIVEDHarper JD, Metzler I, Hall MK, Chen TT, Maxwell AD, Cunitz BW, Dunmire B, Thiel J, Williams JC, Bailey MR, Sorensen MD. First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies. J Endourol. 2021 Apr;35(4):506-511. doi: 10.1089/end.2020.0725. Epub 2020 Nov 5.
PMID: 32940089DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael R Bailey, PhD, MS
University of Washington
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Some outcomes assessors will be blinded to the treatment conditions. This will include review of video data for tissue injury.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Adjunct Professor, Surgery
Study Record Dates
First Submitted
March 9, 2019
First Posted
March 13, 2019
Study Start
August 8, 2019
Primary Completion
December 31, 2025
Study Completion
April 30, 2026
Last Updated
July 10, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share