Using Ultrasound to Break and Move Urinary Stones without Anesthesia Feasibility Study Including People with Spinal Cord Injury

What this Trial Is About

Researchers are evaluating the clinical feasibility of using ultrasound technologies to help break and reposition urinary stones without anesthesia. This study is prospective, open-label, and conducted across multiple centers. It includes people with kidney stones and aims to assess the safety and effectiveness of these ultrasound methods in facilitating stone passage. The study involves several phases an initial feasibility phase with 20 subjects, a randomized control trial phase with 100 subjects divided equally into treatment and control groups, and a feasibility phase focusing on individuals with spinal cord injury. The investigational treatment uses two ultrasound technologies called Burst Wave Lithotripsy and Ultrasonic Propulsion, which noninvasively fragment and move stones within the kidney and ureter. Treatments last up to 30 minutes per session, with possible repeat sessions after 21 days or on the opposite kidney side after imaging. Participants will undergo ultrasound treatments and follow-up imaging to monitor stone fragmentation and movement. Safety is monitored by tracking healthcare visits and adverse events up to 14 months after the procedure. Effectiveness is measured by stone size reduction, residual stone volume, need for further stone management, and patient-reported quality of life. The study includes ongoing monitoring and assessments over several months, ensuring comprehensive evaluation of the investigational technologies.

Ultrasound to Facilitate Stone Passage