Detection and Evaluation of Renal Injury in Burst Wave Lithotripsy Using Ultrasound and Magnetic Resonance Imaging.
Philip C May, Wayne Kreider, Adam D Maxwell...
https://pubmed.ncbi.nlm.nih.gov/28521550Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03873259
Burst Wave Lithotripsy for Breaking Up Urinary Tract Stones: Intraoperative Safety and Effectiveness Evaluation
Led by University of Washington · Updated on 2026-05-13
40
Participants Needed
2
Research Sites
17 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 new technique being studied to break up kidney and ureteral stones using repeated bursts of low-amplitude ultrasound. Unlike traditional shock wave lithotripsy, which uses a single high-energy shock wave, BWL applies multiple cycles of sound waves to fracture stones. This single-arm feasibility study aims to test how well BWL can fragment stones in humans during surgery. The study involves one group where participants receive BWL treatment during a standard ureteroscopic laser stone removal procedure while under anesthesia. Stones treated are limited to 12 mm or smaller. The BWL device delivers treatment with specific parameters including a 350 kHz frequency, 7 MPa peak pressure, 20-cycle pulse duration, and pulses repeated at 17 Hz. Each stone can receive up to 10 minutes of treatment, with a maximum of three stones treated per participant. Participants will be monitored during and after treatment through visual inspection of tissue with a ureteroscopic camera and assessment of stone fragments removed by basket. Safety is tracked by observing tissue injury and recording any adverse events or unexpected medical visits up to 120 days after the procedure. Effectiveness is measured by the volume of stone fragments smaller than 2 mm and the time taken to fully fragment the stones on the day of treatment. The study is conducted at two US centers and plans to treat up to 40 subjects.
CONDITIONS
Brief Title
Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals with at least one kidney stone visible on CT scan
- Scheduled for clinical stone removal using ureteroscopy (URS)
- Age 18 years or older
You will not qualify if you...
- Under 18 years of age
- Pregnant, mentally disabled, prisoner, or other vulnerable group
- Have uncorrected bleeding disorders or coagulopathies
- Taking a clinically significant anticoagulant dose at the procedure time
- Have calcified abdominal aortic or renal artery aneurysm
- Have only one functioning kidney
- Have other medical risks making BWL a poor candidate per physician judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - Day 0
Participants undergo burst wave lithotripsy during their standard ureteroscopic stone removal procedure under anesthesia.
1 intraoperative visit (in-person)
Follow-up
Duration - Up to 120 days post-procedure
Participants are monitored for safety and effectiveness after the procedure, including adverse event assessments and stone fragmentation evaluation.
Approximately 3 to 4 follow-up visits
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
B
Barbrina Dunmire
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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Published Research Related To This Trial
Fragmentation of urinary calculi in vitro by burst wave lithotripsy.
Adam D Maxwell, Bryan W Cunitz, Wayne Kreider...
https://pubmed.ncbi.nlm.nih.gov/25111910Improving Burst Wave Lithotripsy Effectiveness for Small Stones and Fragments by Increasing Frequency: Theoretical Modeling and Ex Vivo Study.
Michael R Bailey, Adam D Maxwell, Shunxiang Cao...
https://pubmed.ncbi.nlm.nih.gov/35229652First In-Human Burst Wave Lithotripsy for Kidney Stone Comminution: Initial Two Case Studies.
Jonathan D Harper, Ian Metzler, Michael Kennedy Hall...
https://pubmed.ncbi.nlm.nih.gov/32940089