Ultrasound to Facilitate Stone Passage
Start Date
4/1/2023
Completion Date
10/31/2028
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.
Detailed 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 has not yet started for Phase 2a. Up to 3 distinct targets may be treated per subject. The maximum total dose exposure is 30 minutes for one session. Subjects may return after at least 21 days and after all AEs have resolved for an additional session on the same side. Subjects may return after imaging follow-up for inclusion of their contralateral side.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)
Conditions
Locations
Indiana University Health - North Hospital
Carmel, Indiana 46032
United States
VA Puget Sound Health Care System
Seattle, Washington 98108
United States
University of Washington
Seattle, Washington 98195
United States