A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)

What this Trial Is About

Researchers are evaluating a new tool called VISOR in adults aged 18 to 80 who have kidney or ureter stones measuring 1 to 3 cm. The study aims to determine if VISOR is safe and effective in clearing stones during surgery by using its built-in features such as flushing, suction, pressure control, and stone-breaking and removal. The main questions are whether VISOR can clear stones successfully for at least 90% of participants within 24 hours after surgery, keep serious complications below 5%, and maintain safe pressure levels inside the kidney during the procedure. All participants will undergo stone removal surgery using the investigational VISOR device. This device integrates irrigation and suction with real-time pressure monitoring to keep kidney pressure below 30 mmHg during surgery. It uses a holmium laser to break stones while simultaneously removing fragments. After surgery, participants will have a CT scan within 24 hours to check if stones are cleared, followed by a follow-up imaging test (CT or ultrasound) around 4 weeks later to monitor any complications and the longer-term stone-free rate. Participants will be closely monitored during and after surgery with continuous pressure tracking and assessments for any ureteral injuries or infections. They will attend a follow-up visit about 4 weeks after surgery for imaging and health evaluation related to the procedure. Researchers will measure the immediate and 1-month stone-free rates, operative time, intraoperative kidney pressure, and rates of complications to evaluate the safety and effectiveness of VISOR. Total participation includes surgery, immediate post-op imaging, and follow-up within about one month.

A Single-Center Clinical Study on the Efficacy and Safety of VISOR