The purpose of this research is to evaluate the safety and performance of the investigational Medtronic Hugo™ Robotic Assisted Surgery (RAS) system when used during hysterectomy procedures, including patients being treated for cancer.
This study will enroll up to 70 subjects and conducted using up to five investigational sites in the United States (US).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
Patients indicated for Robotic Assisted-Surgery (RAS) hysterectomy procedures will have the RAS surgery using the Medtronic Hugo™ RAS system.
Ascension St. Vincent's Riverside
Jacksonville, Florida, United States
RECRUITINGThe University of South Florida
Tampa, Florida, United States
RECRUITINGDuke University
Durham, North Carolina, United States
RECRUITINGAllegheny Health Network - West Penn
Pittsburgh, Pennsylvania, United States
RECRUITINGSurgical success rate
Surgical success rate is the procedure utilizing Hugo™ as outlined in the preoperatively defined surgical plan without conversion to an alternative robotic-assisted system, laparoscopy, or open surgery.
Time frame: Intraoperative
Operative time
Time from skin incision to skin closure
Time frame: Intraoperative
Hospital length of stay
Hospital length of stay from the date of the procedure to discharge
Time frame: From procedure to discharge, through approximately 30 days
Major complication rate
Overall rate of subjects with one or more complication (Clavien-Dindo Grade III or higher) related to study device and/or procedure, from the first incision through 30 days post-procedure.
Time frame: 30 Days
Complication rate
Overall rate of subjects with one or more complications (Clavien-Dindo Grade I or higher) related to study device and/or procedure, from the first incision through 30 days post-procedure.
Time frame: 30 Days
Rate of intraoperative adverse events
Rate of intraoperative adverse events related to study device and/or procedure from first incision through skin closure.
Time frame: Intraoperative
Rate of readmission
Rate of readmission within 30 days due to device and/or procedure related adverse events.
Time frame: 30 Days
Rate of therapy-specific adverse events
Rate of complications due to the study device and/or procedure.
Time frame: 3 Months
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