The first United States prospective trial using the Hugo™ robot-assisted surgery system

To describe the safety and effectiveness of the Hugo™ robot-assisted surgery (RAS) system (Medtronic, Minneapolis, MN, USA) when used for three urological procedures.

The Expand URO (ClinicalTrials.gov identifier: NCT05696444) was the first investigational study for the Hugo RAS system based in the United States. It was a prospective, single-arm, multicentre clinical trial conducted at six medical centres. Patients indicated for radical prostatectomy (RP), radical cystectomy (RC), or partial or radical nephrectomy were enrolled from December 2022 to September 2024. The primary effectiveness endpoint was surgical success (freedom from conversion) and was hypothesised to be >85% for the three procedures combined. The primary safety endpoint was the 30-day major complication (Clavien-Dindo Grade ≥III) rate, hypothesised to be below 20%, 45%, and 20% for RP, RC, and nephrectomy, respectively. Secondary endpoints included operative characteristics and postoperative outcomes through 30 days.

A total of 144 patients were enrolled, and 137 underwent a procedure (55 RPs, 29 RCs, 53 nephrectomies). The conversion rate was low (1.5%) resulting in a surgical success rate of 98.5% across all procedures. The major complication rates for RP, RC, and nephrectomy were 3.7%, 17.9%, and 1.9%, respectively. Of the 137 treated patients, 124 were oncological patients. The overall positive surgical margin rates were 21.8%, 7.1%, and 2.4% in RP, RC, and nephrectomy, respectively.

The Expand URO study achieved its primary endpoints for safety and effectiveness. Operative characteristics and short-term postoperative outcomes obtained with the Hugo RAS system were consistent with those in the literature.