ZAMENIX™ R, ROBOTIC-ASSISTED RETROGRADE INTRARENAL SURGERY SYSTEM FOR RENAL STONE REMOVAL AND ITS EFFICACY AND SAFETY EVALUATION

Abstract

We introduce Zamenix™ R, a novel robotic retrograde intrarenal surgery (RIRS) system that can remotely control a ureteroscope, laser, and stone basket. The efficacy and safety of the system were explored in an in vivo comparative pilot study using a porcine model and a multicenter, prospective, single-arm, pivotal human clinical trial. In the in-vivo test, 10 pigs were randomly divided into two groups: conventional RIRS and robotic RIRS. Three surgeons with different RIRS proficiency participated and they performed two tasks: 1) Stone retrieval test, then followed by 2) Stone fragmentation and retrieval test. In the clinical study, forty-seven adult patients who have one or more stones with a maximum size of 5-30 mm were recruited. The stone-free rate was 93.5%. The postoperative complication rate was 6.5% with three cases of Grade II urinary tract infection (Clavien-Dindo Classification). The experimental results demonstrated the feasibility and comparable safety to conventional RIRS with improved operator’s fatigue and radiation exposure.