(UroToday.com) Dr. Michael Abern presented the highly anticipated primary results from the Expand URO study, a prospective, multi-center clinical trial evaluating the effectiveness, safety, and performance of the Hugo™ robotic-assisted surgery system (Medtronic) across the U.S. urologic population. This study marks a major milestone for Medtronic as it seeks to establish a competitive foothold in the robotic surgery space.
The Expand URO study enrolled 137 patients across six centers in the United States, covering a broad range of urologic procedures, including prostatectomy, nephrectomy, and cystectomy. The study achieved its primary endpoints of safety and effectiveness. Hugo™ demonstrated a Clavien Dindo grade III or greater complication rate of 3.7% for prostatectomy, 1.9% for nephrectomy, and 17.9% for cystectomy, and a low 1.5% conversion rate to another FDA-approved robotic-assisted surgery system — results that compare favorably to historical benchmarks with established robotic platforms.
The Hugo™ system, featuring an independent arm-cart design and a modular console, was designed with the goal of improving OR efficiency, reducing equipment footprint, and expanding global access to robotic surgery. Dr. Abern emphasized the system's flexibility, noting that the modular setup allowed for tailored configurations based on the surgical procedure and surgeon preference.
Dr. Abern highlighted the system’s ergonomic improvements and the intuitive interface, which were well received by surgeons across varying levels of prior robotic experience. Surgeons reported high satisfaction scores related to system usability, visualization quality, and overall procedural control. Additionally, the study reinforced the Hugo™ system’s safety profile with no unanticipated adverse device effects.
The presentation concluded with Dr. Abern acknowledging the broader significance of the Expand URO findings: demonstrating that the Hugo™ robotic-assisted surgery system is a viable, effective, and safe platform for a variety of urologic procedures. These results may pave the way for broader adoption and increased competition in the robotic surgery marketplace, with the ultimate goal of improving patient access and reducing procedure costs.
Presented by: Michael Abern, MD, Associate Professor of Urology, Member of the Duke Cancer Institute, Durham, NC
Written by: Bruce Gao, Endourology Fellow, Department of Urology, University of California, Irvine. @b_gao on Twitter during the American Urological Association's 2025 Annual Meeting, between April 26 – 29, 2025, in Las Vegas, NV.