Ultrasound Technology to Fragment and Reposition Urinary Stones
University of Washington
Summary
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.
Description
This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia. Subjects will be included across three phases: * Phase 1: 20 subjects to demonstrate initial feasibility * Phase 2a: 100 subjects for a two-arm (50:50) randomized control trial (RCT) * Phase 2b: 20 subjects to demonstrate feasibility in individuals with spinal cord injury (SCI) This study has completed Phase 1. The study is currently recruiting for Phase 2b. Recruitment h…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Individuals presenting with at least one kidney stone * Stone with maximum dimension \> 2 mm and ≤ 7 mm as determined by clinical imaging * Individuals with SCI - (Phase 2b only) Exclusion Criteria: * Individuals under 18 years of age * Individuals who are pregnant or who are trying to get pregnant * Prisoners * with cognitive impairment that would limit their ability to comprehend their role in consent or participation. * Individuals who are unable to read or understand English * Individuals who are unable or unwilling to participate in follow up activities * Individu…
Interventions
- DeviceBurst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short 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. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.
Locations (3)
- Indiana University Health - North HospitalCarmel, Indiana
- VA Puget Sound Health Care SystemSeattle, Washington
- University of WashingtonSeattle, Washington