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
Qualifiers
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
Treatments tested in this trial
- Burst Wave Lithotripsy
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Washington
Lead sponsor
Indiana University
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov