Comparing Robotic ILY System and Manual Flexible Ureteroscopy for Treating Kidney Stones in Adults Undergoing Laser Lithotripsy

What this Trial Is About

Researchers are comparing robotic-assisted flexible ureteroscopy using the ILY4 robotic system with manual flexible ureteroscopy for treating kidney stones in adults. The study aims to evaluate whether the robotic system matches or improves efficacy, ergonomics, and safety outcomes, including complication rates and surgeon radiation exposure. The research is designed as a randomized controlled trial to assess these clinical questions in patients undergoing laser lithotripsy for kidney stones. Participants will be randomly assigned to one of two groups one receiving flexible ureteroscopy performed with the ILY robotic system, and the other receiving standard manual flexible ureteroscopy. Both groups will undergo laser lithotripsy as part of their treatment. The study compares intraoperative parameters, ergonomics, radiation exposure to the surgeon, and conversion rates between the two approaches. During the study, participants will complete standard pre- and postoperative assessments and will be evaluated for stone-free status using a non-contrast CT scan 30 days after the procedure. Researchers will also monitor perioperative and 30-day postoperative complications. The primary outcome is the stone-free rate at 30 days. The study includes safety monitoring and ergonomic assessments immediately and during the procedure. Total participation includes follow-up at 30 days post-procedure.

ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment