This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS procedures.
A prospective, multicenter, single-arm pivotal study in subjects undergoing a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic indication will be followed for 30 days post-procedure. Oncologic subjects will be followed annually through 5 years. The study will be conducted in up to 6 investigative sites in the United States of America (USA).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Subjects indicated for Robotic Assisted Surgery (RAS) for prostatectomy will have RAS surgery using the Medtronic Hugo RAS system.
Subjects indicated for Robotic Assisted Surgery (RAS) for cystectomy will have RAS surgery using the Medtronic Hugo RAS system.
Subjects indicated for Robotic Assisted Surgery (RAS) for nephrectomy (Radical/Partial) will have RAS surgery using the Medtronic Hugo RAS system.
City of Hope
Duarte, California, United States
University of Chiago
Chicago, Illinois, United States
Mount Sinai
New York, New York, United States
Duke Medical Center
Durham, North Carolina, United States
Primary Effectiveness Endpoint - Surgical Success Rate, Defined as the Procedure Not Going Into Conversion
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.
Time frame: During surgical procedure
Primary Safety Endpoint - Rate of Subjects With Complications Meeting Grade III - Grade V Criteria Per the Clavien-Dindo Classification System.
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
Time frame: 30 days
Secondary Endpoint - Overall Complication Rate From First Incision Through 30 Days Post-procedure.
Complication rate: Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher), from the first incision through 30 days post-procedure.
Time frame: 30 days
Secondary Endpoint - Operative Time (Min)
Operative time shall be collected through the length of the procedure.
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Cleveland Clinic
Cleveland, Ohio, United States
Swedish Medical Center
Seattle, Washington, United States
Time frame: up to 720 minutes
Secondary Endpoint - Intraoperative Estimated Blood Loss (mL).
Intraoperative estimated blood loss shall be collected through the length of the procedure.
Time frame: intraoperative
Secondary Endpoint - Transfusion Rate Through 30 Days.
Transfusion rate shall be collected through 30 days post-procedure
Time frame: 30 days
Secondary Endpoint - Rate of Device-related Conversions
Rate of device-related conversions shall be collected through the length of the procedure.
Time frame: intraoperative
Secondary Endpoint - Hospital Length of Stay (Days)
Hospital length of stay (days) shall be collected through 30 days post-procedure.
Time frame: 30 days
Secondary Endpoint - Readmission Rate (Through 30 Days)
Readmission rate shall be collected though 30 days post-procedure.
Time frame: 30 days
Secondary Endpoint - Reoperation Rate (Through 30 Days).
Reoperation rate shall be collected through 30 days post-procedure.
Time frame: 30 days
Secondary Endpoint - Mortality Rate (Through 30 Days).
Mortality rate shall be collected through 30 days post-procedure.
Time frame: 30 days
Secondary Endpoint - Progression-free Survival
Progression-free survival rate will be assessed through 5 years in oncologic subjects.
Time frame: 5 years
Secondary Endpoint - Disease-free Survival
Disease-free survival rate will be assessed through 5 years in oncologic subjects.
Time frame: 5 years
Secondary Endpoint - Overall Survival
Overall survival rate will be assessed through 5 years in oncologic subjects.
Time frame: 5 years