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 is currently in Phase 1. Phase 2a and 2b are intended to be conducted in parallel and will not be initiated until after review of the Phase 1 results and approval to proceed to Phase 2 by the FDA.~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.
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.