Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Washington
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals presenting with at least one kidney stone apparent on CT
Individuals scheduled for clinical stone removal via ureteroscopy (URS)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Burst Wave Lithotripsy
DeviceFragment upper urinary tract stones
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Treatment GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety - Area of Tissue Injury
The primary safety endpoint is the area of hemorrhage observed through direct visualization with the ureteroscope.
Time frame
Day 0 - the day of the experimental procedure immediately following the acoustic procedure.2
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.
Time frame
Day 0 - the day of the experimental procedure immediately following the acoustic procedure.Secondary outcomes
1
Safety - Adverse Event Assessment
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
Time frame
out to 120 days post-procedure2
Effectiveness - Time to Full Comminution
projected time to full comminution defined as the time at which no fragments would be ≤ 2 mm
Time frame
Day 0 - the day of the experimental procedure immediately following the acoustic procedure.Sponsors and contacts
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University of Washington
Lead sponsor
Indiana University
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov