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

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

Inclusion Criteria:

• Males or females ≥ 18 years old
• Patients with a normal pelvicalyceal anatomy
• Patients with renal stone diagnosis confirmed by noncontrast computed tomography regardless of stone size, location, and multiplicity
• ASA score I-III
• Intact mental and cognitive ability to provide informed consent and willingness to participate in the study with 30-day follow-up

Exclusion Criteria:

• Children < 18 and pregnant women
• Patients with anatomically anomalous kidneys, known case of stricture or stenosis, or recent 3-month history of ureteroscopy (DJ stent placement only will be accepted) or known history of complicated ureteroscopy
• Patients in whom stone measurement was not feasible on NCCT or those with concomitant ureteric stones.
• ASA score IV
• Mentally incapacitated patients unable to provide informed consent