Early Evaluation of Safety and Efficacy of Robotic-Assisted Combined IntraRenal Surgery with the MONARCH™ Platform

Percutaneous nephrolithotomy (PCNL) is the standard of care for treating complex renal stones, but only a minority of urologists in the United States independently obtain percutaneous access. The MONARCH™ Platform, Urology, is an FDA-cleared robotic platform that may simplify percutaneous access and efficiently treat complex renal stones. In this study, we evaluate the clinical, procedural, and patient-reported outcomes using this technology.

In a preliminary prospective study in two institutions (University of Wisconsin and Indiana University), patients were enrolled to undergo robotic-assisted mini-PCNL with combined ureteroscopic lithotripsy and followed up to 90 days post-procedure. Percutaneous access was gained using electromagnetic guidance while the patient was in a modified supine position. Stones were removed using a handheld controller to manipulate multiple instruments (i.e., retrograde ureteroscope, laser fiber, basket, flexible antegrade suction catheter) and control a fluid management system.

Fifteen patients with median (range) linear stone burden of 32.6 (15.0-72.8) mm were enrolled. In 100% of cases, percutaneous access was successfully gained using this technology, and in 73.3% of cases this was achieved within a single attempt. Within this limited and highly heterogeneous study population, we achieved a postoperative day 30 median (range) volume reduction in stone burden of 98.8 (51.9-100.0)% and a stone-free rate (≤4 mm) of 50.0%. One perioperative Grade 3 complication occurred.

Our initial experience suggests a future where the MONARCH™ Platform may provide urologists with expanded capabilities for safe and effective treatment of select patients with nephrolithiasis.