NCT06996587

ILY Robotic System vs Manual Flexible Ureteroscopy for Kidney Stone Treatment

A Randomized Controlled Trial Comparing Efficacy, Ergonomics, and Safety of ILY Robotic System vs Manual Flexible Ureteroscopy in Patients Undergoing Laser Lithotripsy for Kidney Stones

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Albert El Hajj · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the efficacy, ergonomics, and safety of robotic versus manual flexible ureteroscopy (fURS) for kidney stone treatment in adult patients undergoing laser lithotripsy. * Does robotic-assisted lithotripsy using the ILY® robot have the same efficacy as the manual fURS in treating kidney stones? * Is robotic flexible ureteroscopy associated with similar or improved safety outcomes, including perioperative and 30-day postoperative complication rates? * Does the robotic system offer improved ergonomics, lower surgeon radiation exposure, and favorable intraoperative metrics compared to manual flexible ureteroscopy? Researchers will compare the ILY robotic system with manual fURS to see if robotic intervention can match or improve clinical and ergonomic outcomes. Participants will: * Be randomly assigned to undergo laser lithotripsy with either the ILY robot or manual flexible ureteroscopy * Complete standard pre- and postoperative assessments * Undergo evaluation for stone-free status using a non-contrast CT scan at 30 days postoperatively * Undergo evaluation for postoperative complications

Conditions

• Kidney Stones
• Urolithiasis

Interventions

Type	Name	Description
PROCEDURE	Robotic-Assisted Flexible Ureteroscopy	Use of the ILY® robotic system to perform flexible ureteroscopy.
PROCEDURE	Manual Flexible Ureteroscopy	Conventional flexible ureteroscopy performed manually by the surgeon.

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-04-01
• Completion: 2027-08-01
• First posted: 2025-05-30
• Last updated: 2025-05-30

Locations

1 site across 1 country: Lebanon