Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness
University of Washington
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.
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 o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceBurst Wave Lithotripsy
Fragment upper urinary tract stones
Locations (2)
- IU Health North HospitalCarmel, Indiana
- University of Washington Medical CenterSeattle, Washington