RAS Prostatectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.
RAS Cystectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
RAS Nephrectomy: Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
Study summary
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
Eligibility
Sex
ALL
Min age
22 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion — During surgical procedure 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.
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System. — 30 days Complications meeting Grade III criteria or higher per the Clavien-Dindo Classification system, from first incision through 30 days post-procedure.
Clavien-Dindo Classification of Surgical Complications:
Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.
Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III: Requiring surgical, endoscopic or radiological intervention Grade IIIa: Intervention not under general anesthesia Grade IIIb: Intervention under general anesthesia Grade IV: Life-threatening complication requiring IC/ICU management Grade IVa: Single organ dysfunction (including dialysis) Grade IVb: Multiorgan dysfunction Grade V: Death of a patient
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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