First prospective clinical assessment of the ILY ® robotic flexible ureteroscopy platform.

PURPOSE: To present the initial prospective clinical assessment of the ILY® robotic ureteroscopy manipulator platform, focusing on its safety and effectiveness.

METHODS AND MATERIALS: Data gathered from 31 kidney units which underwent elective robotic flexible ureteroscopy (FURS) for renal stone management utilizing the ILY® robotic system. Patient demographics, stone characteristics, surgical durations, perioperative and post-operative complications, and follow-up parameters were collected. Our primary outcome was evaluating the efficacy and safety of the ILY® robotic ureteroscopy for treating kidney stones. Therefore, we analyzed complication rates, surgical durations, and the stone-free rate during follow-up.

RESULTS: Our cohort consisted of 29 patients, presenting with 45 stones with a median volume of 736.22 mm3. The median operation time was 85 min, accompanied by 3 min for robot draping, 3.5 min for robot docking, 48 min of console operation, and lasing time of 36.75 min. Post operative stay for all patients was 1 day, while complications were observed in 9.68% of cases. Notably, all complications were classified as CVD (Clavien-Dindo) class 1 due to pain requiring emergency department visit. The stone-free rate achieved was 93.55%, and none of the patient required reoperation for the treated stone.

CONCLUSION: In the first prospective clinical experience of the ILY® robotic FURS, we demonstrated its efficacy and safety. To further investigate its clinical practical value, additional investigations are warranted, including direct comparative analyses with manual flexible ureteroscopy techniques.