NCT04796792

Ultrasound to Facilitate Stone Passage

Ultrasound Technology to Fragment and Reposition Urinary Stones

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Urinary Stone
• Urinary Calculi

Interventions

Type	Name	Description
DEVICE	Burst 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.

Timeline

• Start date: 2023-04-01
• Primary completion: 2028-05-31
• Completion: 2028-10-31
• First posted: 2021-03-15
• Last updated: 2025-12-09

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study