Comparing Steerable Ureteroscopic Renal Evacuation Using the CVAC System Versus Standard Ureteroscopy with Laser Lithotripsy for Treating Kidney Stones

What this Trial Is About

Researchers are comparing two methods for treating kidney stones Steerable Ureteroscopic Renal Evacuation SURE using the CVAC System and standard ureteroscopy URS with laser lithotripsy. This is a prospective, randomized, multi-center study focusing on the treatment of urolithiasis, which involves kidney stones. The study aims to evaluate the safety and effectiveness of these two approaches. Participants will receive either the SURE treatment using the CVAC System, a single-use, steerable ureteral catheter with integrated vision, irrigation, and aspiration designed to remove urinary stones, or standard ureteroscopy where a laser breaks the stone into small pieces and a stent is placed to help remaining fragments pass. The treatments are given in parallel groups, and participants are randomly assigned to one of the two methods. During the study, participants will be monitored for residual stone volume at 30 days after treatment. They will need to return for follow-up visits to assess their progress and respond to study-related procedures. Researchers will collect data on stone removal effectiveness and safety outcomes. The total study period extends until July 2029, with primary outcome completion expected by July 2027.

Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology