Trial results for the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in urologic surgery were posted on ClinicalTrials.gov on 2025-11-25, showing a surgical success rate of 134 participants who did not require conversion to open surgery.
Background
Robotic-assisted surgery has become an increasingly important modality in various surgical specialties, including urology. Conditions such as bladder cancer, prostate cancer, kidney cancer, pelvic tumors, and interstitial cystitis often require complex surgical interventions. Robotic systems aim to enhance surgical precision, improve patient outcomes, and potentially reduce recovery times compared to traditional open surgery. The evaluation of new robotic platforms like the Medtronic Hugo™ RAS System is crucial to establish their safety and performance across a range of urologic procedures, providing clinicians with data to inform surgical practice.
Trial design
This study, designated as Phase NA, enrolled 144 participants to evaluate the safety and performance of the Medtronic Hugo™ RAS System for urologic robotic-assisted surgical procedures. The trial included participants undergoing surgery for various conditions, including Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor, and Interstitial Cystitis. The primary effectiveness endpoint was defined as the surgical success rate, specifically the procedure not requiring conversion to open surgery. Primary safety endpoints focused on the rate of subjects experiencing complications meeting Grade III to Grade V criteria per the Clavien-Dindo Classification System. The study was designed as a single-arm evaluation of the Medtronic Hugo™ RAS System.
Key results
The trial results detailed both effectiveness and safety outcomes for the Medtronic Hugo™ RAS System:
- Primary Effectiveness Endpoint - Surgical Success Rate: For robotic-assisted urologic surgery, 134 participants did not go into conversion.
- Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System:
- For prostatectomy procedures, 2 participants experienced such complications.
- For cystectomy procedures, 5 participants experienced such complications.
- For nephrectomy procedures, 1 participant experienced such complications.
- Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure:
- Across the full analysis set with available data, 31 participants experienced complications.
- Specifically for cystectomy procedures, 24 participants experienced complications.
- For nephrectomy procedures, 24 participants experienced complications.
- Secondary Endpoint - Operative Time (Minutes):
- For prostatectomy, the mean operative time was 227.8 minutes (Standard Deviation 54.01).
- For cystectomy, the mean operative time was 357.8 minutes (Standard Deviation 83.26).
- For nephrectomy, the mean operative time was 178.7 minutes (Standard Deviation 69.52).
- Secondary Endpoint - Intraoperative Estimated Blood Loss (mL):
- For prostatectomy, the mean estimated blood loss was 161.5 mL (Standard Deviation 89.34).
- For cystectomy, the mean estimated blood loss was 394.7 mL (Standard Deviation 380.29).
Statistical analyses reported p-values of 0.0001, 0.0006, 0.0025 (against a null value of 0.45), and 0.0001 (against a null value of 0.2).
What this means
The posted results indicate that the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System demonstrated favorable safety and performance metrics in a cohort of 144 participants undergoing various urologic procedures. The high surgical success rate, with 134 participants not requiring conversion to open surgery, suggests the system's effectiveness in completing robotic-assisted procedures as intended. The low rates of severe complications (Grade III-V) across prostatectomy, cystectomy, and nephrectomy procedures, with 2, 5, and 1 participant respectively, support the system's safety profile. The provided operative times and estimated blood loss figures offer important benchmarks for surgeons utilizing the Hugo RAS System for these complex urologic interventions. These findings collectively suggest that the Medtronic Hugo™ RAS System is a viable option for robotic-assisted urologic surgery, potentially offering benefits for patients with conditions like bladder cancer, prostate cancer, and kidney cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05696444, titled "Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)", were posted on 2025-11-25 on clinicaltrials.gov.