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

Area of Science:

• Urology
• Surgical Technology
• Robotic Surgery

Background:

• Robot-assisted surgery (RAS) is increasingly adopted for complex urological procedures.
• Evaluating new RAS systems is crucial for advancing minimally invasive surgical techniques.
• The Hugo™ RAS system represents a novel platform for urological interventions.

Purpose of the Study:

• To assess the safety and effectiveness of the Hugo™ RAS system.
• To evaluate the system's performance in three distinct urological procedures: radical prostatectomy (RP), radical cystectomy (RC), and nephrectomy.
• To compare outcomes with established literature benchmarks.

Main Methods:

• The Expand URO trial (NCT05696444) was a prospective, single-arm, multicentre study.
• 144 patients undergoing RP, RC, or nephrectomy were enrolled.
• Primary endpoints included surgical success (conversion rate) and 30-day major complication rates (Clavien-Dindo Grade ≥III).

Main Results:

• Surgical success rate was 98.5% with a low conversion rate of 1.5%.
• Major complication rates were 3.7% (RP), 17.9% (RC), and 1.9% (nephrectomy), meeting predefined safety hypotheses.
• Positive surgical margin rates were 21.8% (RP), 7.1% (RC), and 2.4% (nephrectomy).

Conclusions:

• The Hugo™ RAS system met its primary safety and effectiveness endpoints in the Expand URO study.
• Operative characteristics and short-term outcomes align with existing literature for RAS.
• The Hugo™ RAS system is a viable option for complex urological procedures.