Hugo robot-assisted surgery system shows promise for urologic procedures

The Expand URO IDE study (NCT05696444) met its primary efficacy and safety end points, supporting the use of the Hugo robot-assisted surgery system in patients undergoing urologic procedures, according to data presented at the 2025 American Urological Association (AUA) Annual Meeting in Las Vegas, Nevada.¹

The results were shared by Michael R. Abern, MD, an associate professor of urology at Duke University School of Medicine in Durham, North Carolina.

Michael R. Abern, MD

“The Hugo robotic surgical platform obtained a CE mark in Europe and was introduced for clinical use in 2021. There are numerous international publications describing case series of primarily urologic surgeries performed outside of the US,” Abern explained. “For those of you unfamiliar, the Hugo robot is a multi-port robotic surgical system with modular independent arm carts, an open surgical console, and a tower containing a light source, endoscope processor, and bipolar and monopolar energy generator.”

In total, 137 patients were enrolled in the study and underwent a urologic procedure with the Hugo system. Of these, 55 underwent prostatectomy, 29 underwent cystectomy, and 53 underwent partial (n = 36) or radical (n = 17) nephrectomy.

The primary effectiveness end point for the study was surgical success rate, defined as no conversion (the case did not switch to another FDA-cleared robot-assisted device, laparoscopy, or open surgery following the first incision). The primary safety end point was the rate of patients with grade 3 or higher Clavien-Dindo complications from incision to 30 days following surgery.

Across all 3 surgical procedures, the mean time for robot assembly was 17.7 minutes (SD, 17.07), and the mean time for docking was 8.3 minutes (SD, 5.94). Further, the mean time for surgeon console used was 156.2 minutes (SD, 69.82), and the mean total operative time was 237.9 minutes (SD, 94.97). Both the time for surgeon console used and the mean total operative time were longer in the radical cystectomy cohort.

Abern added, “As expected, the operative times were longer in radical cystectomy. The urinary diversion was performed either intra- or extracorporeally at the discretion of the performing surgeon, which explains the larger difference between the console and total operative time in cystectomy. Of note, the warm ischemia time in the partial nephrectomies was 20 minutes.”

Overall, the trial met its primary end points. The surgical success rate was 98.5% (95% CI, 94.8% to 99.8%), which exceeded the performance goal of 85% (P < .0001). The were a total of 2 conversions, both of which occurred in the renal cohort.

“One was a communication issue between the console and one of the surgical arms. The performing surgeon did not feel comfortable performing the surgery with 3 arms instead of 4. In the other case, the performing surgeon felt not able to reach a superior and lateral tumor in a partial nephrectomy. Both cases were converted to alternative robotic surgical platforms and successfully completed,” said Abern.

The study also met its safety end point, demonstrating low rates of grade 3 or higher Clavien-Dindo complications across all 3 procedures.

Specifically, in the prostatectomy arm, 3.7% (95% CI, 0.5% to 12.7%) of patients experienced a grade 3 or higher complication, which was below the performance goal of 20% (P = .0006). In the cystectomy arm, the rate was 17.9% (95% CI, 6.1% to 36.9%), which was below the performance goal of 45% (P = .0025). In the nephrectomy cohort, the rate was 1.9% (95% CI, 0.0% to 10.3%), which fell below the performance goal of 20% (P = .0001).

Regarding the trial’s secondary safety end points, there were 2 deaths in the study; 1 occurred in the radical prostatectomy arm and 1 occurred in the radical cystectomy arm. Both were determined to be unrelated to the study by the Independent Data Monitoring Committee.

Abern also added, “The rates of high-grade complications as well as low-grade complications, length of stay, blood transfusion [rate], and median blood loss were predictably higher in the radical cystectomy cohort.”

Overall, these results are expected to support submission of the Hugo system to the FDA for use in urologic procedures.

Abern concluded, “In summary, the Expand URO study, a prospective multi-center IDE study, completed enrollment and 30-day follow up, and the 5-year oncologic follow-up is ongoing. The predetermined trial end points for safety and efficacy were met, and clinical results from this study are under review by the FDA.”

REFERENCE

1. Abern M, Wiklund P, Goh AC, et al. A prospective, multi-center study assessing effectiveness, safety, and performance of the HUGO robotic-assisted surgery system in the US urologic population: Primary results from the Expand URO IDE study. J Urol. 2025;213(5S2):e4. doi:10.1097/01.JU.0001111604.90306.91.07