Clinical trial · Interventional
Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
NCT05696444CI-TRIAL-00097928active not recruitingN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Congenital Abnormalities | — | UNRESOLVED | — |
| End Stage Renal Disease | — | UNRESOLVED | — |
| Interstitial Cystitis | — | UNRESOLVED | — |
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Kidney Injury | — | UNRESOLVED | — |
| Pelvic Tumor | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Renal Tumor | Kidney Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RAS Cystectomy | Device | — | UNRESOLVED |
| RAS Nephrectomy | Device | — | UNRESOLVED |
| RAS Prostatectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Robotic Assisted Surgery (RAS) Urologic Surgery
- description
- Robotic Assisted Surgery (RAS) urologic surgery under the umbrella of procedures outlined by the FDA (prostatectomy, cystectomy and nephrectomy).
- interventionNames
- Device: RAS Prostatectomy
- Device: RAS Cystectomy
- Device: RAS Nephrectomy
Primary outcomes (2)
- measure
- Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
- timeFrame
- During surgical procedure
- description
- The primary effectiveness endpoint is the surgical success rate, defined as the procedure not going into conversion. Conversion is defined as the switch from a robotic assisted approach using the Hugo system to a robotic assisted approach utilizing an FDA cleared robotic-assisted device, laparoscopic, or open surgery.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: 1. Adult subjects (age ≥ 22 years) as required by local law 2. Subject has been indicated for a radical prostatectomy, radical cystectomy, or nephrectomy (partial or radical) surgical procedure 3. Subject is an acceptable candidate for a fully robotic assisted surgical procedure, a laparoscopic surgical procedure, or an open surgical procedure 4. The subject is willing to participate and consents to participate, as documented by a signed and dated informed consent form Exclusion Criteria: 1. Subjects for which minimally invasive surgery is contraindicated as determined by the Investigator 2. Subjects with comorbidities or medical characteristics, which would preclude the surgical procedure in the opinion of the Investigator 3. Subjects diagnosed with a bleeding disorder and/or cannot be removed from their anticoagulants prior to surgery based on surgeon discretion and standard-of-care 4. Non-oncology subjects with an estimated life expectancy of less than 6 months; oncology subjects considered for cystectomy with a life expectancy less than 24 months; oncology subjects considered for nephrectomy with a life expectancy less than 60 months; oncology subjects considered for prostatectomy with less than a 10-year life expectancy. 5. Female subjects pregnant at the time of the surgical procedure. 6. Subjects who are considered to be part of a vulnerable population (e.g., prisoners or those without sufficient mental capacity) 7. Subjects who have participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study 8. Subjects with active infections including but not limited to pneumonia, urinary tract, cellulitis, or bacteremia
References
Publications (1)
- DERIVEDAbern MR, Wiklund P, Goh AC, Kaouk JH, Crivellaro S, Lau CS, Zhumkhawala AA, Huang R, Mehrazin R, Sfakianos JP, Madueke I, Inman BA, Blaser C, Masters M, Porter JR. The first United States prospective trial using the Hugo robot-assisted surgery system. BJU Int. 2026 Jul;138(1):85-91. doi: 10.1111/bju.70314. Epub 2026 May 14. PMID 42132526