A Prospective, Multi-center, Single-arm Study of the Medtronic Hugo™ Robotic Assisted Surgery (RAS) System in Urologic Surgery (Expand URO)
Phase: NA
Conditions: Bladder Cancer, Prostate Cancer, Kidney Cancer, Pelvic Tumor, Interstitial Cystitis, Congenital Abnormalities, End Stage Renal Disease, Renal Tumor, Kidney Injury
Sponsor: Medtronic - MITG

EXPAND URO 
 
A prospective, multi-center, single-arm study of the Medtronic Hugo™ Robotic Assisted 
Surgery (RAS) System in Urologic Surgery 
Clinical Investigation Plan v9.0                                                                                                              
21/AUG/2024 
NCT05696444  

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1. Investigator Agreement and Signature Page 
 
 
Study Product Name 
Medtronic Hugo™ RAS System 
Sponsor 
Covidien LP, Medtronic 
Medical Surgical 
Surgical Robotics 
60 Middletown Ave. 
North Haven, CT 06473 USA 
Clinical Investigation Plan Identifier 
MDT19051EINURO 
Version Number/Date 
9.0, 21-Aug-2024 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and 
will make a reasonable effort to complete the study within the time designated. 
I agree to comply with the Declaration of Helsinki, the Clinical Investigation Plan, and Good Clinical 
Practice, as well as local laws, regulations, and standards. I agree to ensure that the confidential 
information contained in this document will not be used for any purpose other than the evaluation 
and conduct of the clinical investigation without the prior written consent of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature: 
Investigator’s Name: 
Institution: 
Date: 
 
 
 
 
 
 
 
 
 
 

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Table of Contents 
1. 
Investigator Agreement and Signature Page ........................................................................ 2 
Table of Contents ...................................................................................................................... 3 
2. 
Glossary .............................................................................................................................. 8 
3. 
Synopsis ........................................................................................................................... 11 
4. 
Introduction ..................................................................................................................... 17 
4.1 Background ........................................................................................................................... 17 
4.1.1 
Robotic Surgery ............................................................................................................... 17 
4.1.2 
Robotic Procedures in Urology........................................................................................ 17 
4.1.3 
Medtronic Hugo™ RAS System ....................................................................................... 18 
4.2 Purpose ................................................................................................................................. 18 
5. 
Objectives and/or Endpoints ........................................................................................... 18 
5.1 Objectives ............................................................................................................................. 18 
5.1.1 
Primary Objective ............................................................................................................ 18 
5.1.2 
Secondary Objective ....................................................................................................... 18 
5.1.3 
Primary Endpoints ........................................................................................................... 19 
5.1.4 
Secondary Endpoints....................................................................................................... 19 
5.1.5 
Other Prespecified Outcomes Measures ........................................................................ 19 
6. 
Study Design .................................................................................................................... 20 
6.1 Roll-in Phase .......................................................................................................................... 20 
6.2 Open Enrollment Phase .......................................................................................................... 20 
6.3 Duration ................................................................................................................................ 20 
6.4 Rationale ............................................................................................................................... 20 
6.4.1 
Justification for the Clinical Evaluation ........................................................................... 20 
6.4.2 
Clinical Study Design Justifications ................................................................................. 22 
6.5 Study Oversight ..................................................................................................................... 24 
7. 
Product Description .......................................................................................................... 26 
7.1 General ................................................................................................................................. 26 

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7.1.1 
Hugo™ RAS Surgeon Console .......................................................................................... 26 
7.1.2 
Hugo™ RAS Arm Cart Assembly ...................................................................................... 27 
7.1.3 
Hugo™ RAS Tower, 120v ................................................................................................. 27 
7.1.4 
Hugo™ RAS Endoscope Adapter ...................................................................................... 27 
7.1.5 
Hugo™ RAS Sterile Interface Module .............................................................................. 27 
7.1.6 
Hugo™ RAS Arm Cart Sterile Drapes ............................................................................... 27 
7.1.7 
Wristed Instruments ....................................................................................................... 28 
7.1.8 
Software .......................................................................................................................... 29 
7.2 Manufacturer ......................................................................................................................... 29 
7.3 Packaging .............................................................................................................................. 29 
7.4 Intended Population ............................................................................................................... 29 
7.5 Equipment ............................................................................................................................. 30 
7.6 Product Use ........................................................................................................................... 33 
7.7 Product Training Materials ...................................................................................................... 33 
7.8 Product Receipt and Tracking ................................................................................................. 34 
7.9 Product Storage ..................................................................................................................... 34 
7.10 Product Return ...................................................................................................................... 35 
7.11 Product Accountability ............................................................................................................ 35 
8. 
Study Site Requirements…………………………………………………………………………………35 
8.1 Investigator/Investigation Site Selection .................................................................................. 35 
8.2 Study Site Activation .............................................................................................................. 36 
8.3 Role of the Sponsor Representatives ....................................................................................... 37 
9. 
Selection of Subjects………………………………………………………………………….….……….37 
9.1 Study Population .................................................................................................................... 37 
9.2 Subject Enrollment ................................................................................................................. 37 
9.3 Inclusion Criteria .................................................................................................................... 38 
9.4 Exclusion Criteria ................................................................................................................... 38 
10. 
Study Procedures……………………………………………………………………………………….38 
10.1 Schedule of Events ................................................................................................................. 38 
10.1.1 
Screening Visit (Visit 1) .................................................................................................... 38 

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10.1.2 
Surgical Procedure Visit (Visit 2) ..................................................................................... 39 
10.1.3 
Up to Hospital Discharge (Visit 2.1)................................................................................. 39 
10.1.4 
Post-Operative Follow-Up Visit (Visit 3) .......................................................................... 39 
10.1.5 
Post-Operative Follow-Up Visits (Visit 4-8) ..................................................................... 39 
10.2 Subject Screening .................................................................................................................. 41 
10.3 Prior and Concomitant Medications/Therapies .......................................................................... 42 
10.3.1 
Anticoagulants Taken within 30 Days Prior to Surgery ................................................... 42 
10.3.2 
Monoamine Oxidase Inhibitors (MAOIs) Taken within 30 days Prior to Surgery ............ 43 
10.4 Subject Consent ..................................................................................................................... 43 
10.5 Assessment of Performance .................................................................................................... 44 
10.6 Assessment of Safety ............................................................................................................. 44 
10.7 Recording Data ...................................................................................................................... 45 
10.8 Deviation Handling ................................................................................................................. 46 
10.9 Subject Exit, Withdrawal or Discontinuation ............................................................................. 47 
10.9.1 
Study Exit......................................................................................................................... 47 
10.9.2 
Study Completed ............................................................................................................. 48 
10.9.3 
Lost to Follow-up ............................................................................................................. 48 
10.9.4 
Subject Chooses to Exit (i.e. Revokes Consent) .............................................................. 49 
10.9.5 
Investigator Withdraws Subject ...................................................................................... 49 
10.9.6 
Conditional Disengagement ............................................................................................ 49 
11. 
Risks and Benefits………………………………………………………………………………………49 
11.1 Potential Risks ....................................................................................................................... 49 
11.2 Risk Minimization ................................................................................................................... 51 
11.3 Potential Benefits ................................................................................................................... 51 
11.4 Risk-Benefit Rationale ............................................................................................................ 52 
11.5 Risk Determination ................................................................................................................. 52 
12. 
Adverse Events and Device Deficiencies……………………………………………….………….53 
12.1 Adverse Events ...................................................................................................................... 53 
12.2 Device Deficiency ................................................................................................................... 53 
12.3 Processing Updates and Resolution ......................................................................................... 53 

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12.4 Definitions/Classifications ....................................................................................................... 54 
12.5 Reporting of Adverse Events ................................................................................................... 61 
12.5.1 
Adverse Event and Device Deficiency Classification ....................................................... 61 
12.5.2 
Adverse Event and Device Deficiency Reporting Requirements ..................................... 61 
12.6 Subject Death ........................................................................................................................ 64 
12.6.1 
Death Classification and Reporting ................................................................................. 65 
12.7 Product Complaint Reporting .................................................................................................. 65 
13. 
Data Review Committees ............................................................................................. 66 
13.1 Clinical Events Committee Review ........................................................................................... 66 
13.2 CRO/Core Lab(s) .................................................................................................................... 67 
14. 
Statistical Design and Methods .................................................................................... 68 
14.1 General Aspects of Analysis .................................................................................................... 68 
14.2 Analysis Execution.................................................................................................................. 68 
14.3 Interim Analysis ..................................................................................................................... 68 
14.4 Primary Objectives ................................................................................................................. 68 
14.4.1 
Primary Objective #1 (Effectiveness) .............................................................................. 68 
14.4.2 
Primary Objective #2 (Safety) ......................................................................................... 70 
14.5 Secondary Objectives ............................................................................................................. 71 
14.6 Ancillary Objectives ................................................................................................................ 79 
14.7 Sample Size Determination ..................................................................................................... 79 
14.8 Demographics and Baseline Characteristics .............................................................................. 79 
14.9 Analysis Populations ............................................................................................................... 80 
14.10 Data Poolability .................................................................................................................... 80 
14.11 Missing Data and Sensitivity Analysis ..................................................................................... 80 
14.12 Multiplicity Adjustment ......................................................................................................... 81 
14.13 Minimization of Bias.............................................................................................................. 81 
15. 
Ethics ............................................................................................................................ 81 
15.1 Statement(s) of Compliance .................................................................................................... 81 
16. 
Study Administration….………………………………………………………………………….…….83 
16.1 Monitoring ............................................................................................................................. 83 

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16.1.1 
Monitoring Visits ............................................................................................................. 83 
16.2 Data Management .................................................................................................................. 84 
16.3 Direct Access to Source Data/Documents ................................................................................ 84 
16.4 Confidentiality ........................................................................................................................ 84 
16.5 Liability/Warranty/Insurance Information ................................................................................. 85 
16.6 CIP Amendments ................................................................................................................... 85 
16.7 Record Retention ................................................................................................................... 85 
16.8 Reporting Requirements ......................................................................................................... 86 
16.8.1 
Investigator Reports ........................................................................................................ 86 
16.9 Publication and Use of Information .......................................................................................... 87 
16.9.1 
Publication Committee ................................................................................................... 87 
16.9.2 
Criteria for Determining Authorship ............................................................................... 87 
16.9.3 
Transparency ................................................................................................................... 88 
16.10 Suspension or Early Termination ........................................................................................... 88 
16.10.1 
Planned Study Closure .................................................................................................... 88 
16.10.2 
Early Termination or Suspension .................................................................................... 90 
16.10.3 
Procedures for Termination or Suspension .................................................................... 91 
17. 
References.…………………………………………………………………………………….………….92 
17.1 Bibliography of Publications Supporting Updated Statistical Design ............................................ 94 
18. 
Appendices…………………………………………………………………………………...………….105 
18.1 RAS URO Clavien-Dindo Grades and Examples ....................................................................... 105 
18.2 Report of Prior Investigations................................................................................................ 108 
18.3 Instructions for Use/Labeling ................................................................................................ 108 
18.4 Sample Informed Consent Form ............................................................................................ 108 
18.5 Training Plan ....................................................................................................................... 108 
18.6 List of Monitors .................................................................................................................... 108 
18.7 List of Institutions ................................................................................................................ 108 
19. 
Version History ........................................................................................................... 109 

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Product Status 
Pre-Market 
Primary Objectives 
The primary objectives of this study are to confirm that the Medtronic 
Hugo™ RAS System is safe and effective when used for urologic 
robotic assisted surgery. 
Primary Endpoints 
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. 
The primary safety endpoint is the rate of subjects with 
complications meeting Grade III criteria or higher per the Clavien- 
Dindo Classification system,1 from the first incision through 30 days 
post-procedure. 
Secondary Objective 
The secondary objective of this study is to demonstrate that the 
Medtronic Hugo™ RAS System performs as intended when used in 
urologic robotic assisted surgery. The secondary endpoints of this 
study will assess the overall performance of the Medtronic Hugo™ 
RAS System when used for urologic robotic surgery. 
Secondary Endpoints 
Secondary objectives include descriptive analyses of secondary 
endpoints. 
The following safety and performance data shall be collected through 
30 days post-procedure to assess the overall safety and performance 
of the Medtronic Hugo™ RAS System when used for urologic RAS: 
• 
Complication rate: Overall rate of subjects with one or more 
complication(s) (Clavien-Dindo Grade I or higher), from the 
first incision through 30 days post-procedure 
• 
Operative time 
• 
Intraoperative estimated blood loss (mL) 
• 
Transfusion rate 
• 
Rate of device-related conversion 
• 
Hospital length of stay 
• 
Readmission rate (through 30 days) 
• 
Reoperation rate (through 30 days) 

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• 
Mortality rate (through 30 days) 
• 
Rate of device deficiencies 
The following long-term secondary endpoints will be assessed 
through 5 years in oncologic subjects: 
• 
Overall survival 
• 
Progression-free survival 
• 
Disease-free survival 
Other Prespecified 
Outcomes Measures 
Descriptive analyses of other pre-specified outcome measures beyond 
the primary and secondary objectives will be exploratory in nature 
and are not intended as a focus of the study for the evaluation of the 
study device. 
• 
Rate of positive surgical margins 
• 
Lymph node yield 
• 
Warm ischemia time 
• 
Surgeon experience 
Study Design 
A prospective, multicenter, single-arm pivotal study will be performed 
in up to 141 subjects undergoing a urologic RAS procedure using the 
Medtronic Hugo™ RAS System. Subjects without an oncologic 
indication will be followed for 30 days (+7 days) post-procedure. 
Oncologic subjects will be followed through 5 years. This study will be 
conducted using up to six investigative sites in the United States of 
America (USA). 
Sample Size 
(Roll-in + Open Enrollment) 
A total of up to 141 subjects (up to 31 for Cystectomy; up to 55 for 
Nephrectomy; and up to 55 for Prostatectomy) undergoing a urologic 
robotic assisted procedure will be treated for this study at up to six 
different sites (including 15 roll-in subjects). 
Inclusion/Exclusion Criteria 
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 

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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 thirty (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 
 
 

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Study Procedures and 
Assessments 
Screening, Surgical Procedure, Hospital Discharge, and Post-Discharge 
Follow-Up (see full protocol for data collection/assessment windows): 
Screening: To determine study eligibility and collect baseline 
information (demographics, medications, medical history, surgical 
history, kidney function). 
Surgical Procedure: To re-confirm eligibility criteria, procedure set-up 
and take-down, medications associated with adverse events, 
interoperative complication evaluation, disease state evaluation, 
procedure success, conversion rates, protocol deviation, device 
deficiency and adverse event evaluation. 
Up to Hospital Discharge: Adverse event evaluation, subject 
complication rate, disease state evaluation, protocol deviation and 
medications associated with adverse events. 
Post-Discharge Follow-Up: Adverse event evaluation, subject 
complication rate, disease state evaluation, length of hospital stay, 
readmission (if applicable), reoperation (if applicable), recurrence (if 
applicable), protocol deviation, medications associated with adverse 
events and study exit. 
Safety Assessments 
Adverse events (AEs) will be collected from the time of consent. 
Safety assessments will be based on the full analysis set (FAS). Data 
including AE event type, incidence, severity, duration, and 
procedure/device relatedness will be reported. AEs for all FAS 
subjects will be analyzed from first incision through the study exit. 
AEs will be assessed by the Investigator and the sponsor as well as an 
external independent CEC for events requiring adjudication. 
AEs occurring in subjects excluded from the full analysis set will be 
followed post-consent through study exit and will be reported in a 
listing in the clinical study report (CSR). These AEs will not be included 
in the FAS summary for either AE reporting or the analysis of the 
primary and secondary endpoints. 
Statistics 
Primary Analysis Set 
 
 
 

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The full analysis set (FAS) includes all enrolled subjects in whom the 
Hugo™ RAS procedure is begun, defined as the first skin incision. The 
FAS will be the primary analysis set for the evaluation of the primary 
and secondary endpoints. 
Sample Size 
A total of up to 141 subjects are planned to be treated in the study. 
The sample size will provide more than 80% power to evaluate the 
primary effectiveness endpoint at one-sided alpha of 0.025. A 
performance goal of 85% is pre-defined to test the statistical 
hypothesis. Additionally, separate performance goals are pre-defined 
to assess the primary safety endpoint (rate of subjects with one or 
more major complications) for the three surgery types, and technical 
details are provided in Section 14. 
Primary Hypothesis 
The primary effectiveness hypothesis is to test if the surgical success 
rate is above the performance goal. The primary safety hypothesis is 
to test if the 30-day major complication rate is below the 
performance goal for each of the three surgery types. The major 
complication rate is defined as the rate of subjects with one or more 
adverse event meeting Grade ≥ III per the Clavien-Dindo Classification 
system. 
Other Information 
All secondary endpoints and other prespecified outcome measures 
will be evaluated using descriptive statistics. Statistical analyses will 
be performed using SAS version 9.4 or higher. 
 
 
 
 
 
 
 
 
 
 

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4. Introduction 
4.1 Background 
4.4.1 Robotic Surgery 
Over the course of history, surgery has generally evolved towards less invasive methods for performing 
the same procedures. As surgical diseases are better understood, and adjunct tools such as imaging 
techniques continue to improve, the operative management of these diseases has also become safer, 
more effective, and more elegant. Better outcomes are driven by refinement of surgical procedures, 
such as shorter recovery and less pain while reducing costs in efforts to increase access to robotic 
procedures around the world. 
The first major paradigm shift in the realm of surgical technique came with the introduction of 
laparoscopic surgery. Around the beginning of the 20th century, surgeons in the United States and 
Europe began using rudimentary tools to inspect abdominal cavities of subjects, typically during 
gynecologic procedures, for diagnostic purposes only. The popularity of laparoscopy increased 
substantially with the introduction of the rod-lens optical system and cold light fiber-glass illumination. 
In the late 1980s French and German surgeons performed the first known laparoscopic 
cholecystectomies, which started a boom in the development of laparoscopic surgery.2 Many 
procedures that were once executed in open fashion are now performed entirely laparoscopically as the 
standard of care. 
Presently, surgical technique is undergoing another revolution – the growth of robotic assisted surgery 
(RAS). Much as the laparoscope changed how surgery was practiced in the 20th century, RAS will 
similarly propel forward surgical specialties in the 21st century. RAS is based on the accurate translation 
of user input to a robotically assisted output. Similar to laparoscopic surgery, RAS involves the use of 
endoscopic instrumentation for manipulation of tissues and vessels in the insufflated body cavity. 
However, robotic systems allow for a three-dimensional stabilized view, articulated instruments, and 
superior ergonomics and dexterity.3 
4.4.2 Robotic Procedures in Urology 
Robotic surgery was initially applied to urology in the early 2000s. RAS has now almost entirely replaced 
laparoscopy in the United States.4 RAS adoption for radical prostatectomy increased from 0.7% in 2003 
to 42% in 2010. Published research on robotic surgery has also surged in the last two decades, 
particularly in the field of urology.5 
Systematic reviews and meta-analyses comparing RAS to open and laparoscopic approaches for 
urological procedures have demonstrated similar oncologic outcomes with lower complication rates for 
minimally invasive approaches.6  

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The benefits of RAS compared to open or traditional laparoscopic surgery have been 
demonstrated in meta-analyses for all of the highest-volume4 urology oncologic surgeries: radical 
prostatectomy,7-11 radical cystectomy,12-24 and nephrectomy.25-32 
Currently, most of this research describes the da Vinci™ robotic surgical platform (Intuitive Surgical, 
Sunnyvale, CA). Development of that system started in the early 1990s and it was approved for the 
management of urological procedures in the United States in 2000.33 More recently, Asensus Surgical 
US, Inc. (formerly known as TransEnterix Inc, Morrisville, NC) has entered the market with the 
Senhance™ robotic assisted platform.34-38 
The Medtronic Hugo™ RAS System is a modular robotic platform for performing robotically assisted 
minimally invasive surgery. This study will evaluate the safety and effectiveness of the Medtronic Hugo™ 
RAS System when used for urologic RAS. 
 
4.1.3 Medtronic Hugo™ RAS System 
All necessary design verification and validation activities have been conducted on the Medtronic Hugo™ 
RAS System in compliance with FDA 21 CFR Part 820. Details of all clinical, animal, and laboratory testing 
can be found within the Medtronic Hugo™ RAS System Report of Prior Investigations (Appendix 18.2). 
 
4.2 Purpose 
This study will evaluate the safety and performance of the Medtronic Hugo™ RAS System when used for 
urologic RAS procedures. 
 
5. Objectives and/or Endpoints 
5.1 Objectives 
5.1.1 Primary Objectives 
The primary objectives of this study are to confirm that the Medtronic Hugo™ RAS System is safe and 
effective when used for urologic robotic assisted surgery. 
 
5.1.2 Secondary Objective 
The secondary objective of this study is to demonstrate that the Medtronic Hugo™ RAS System performs 
as intended when used in urologic robotic assisted surgery. The secondary endpoints of this study will 
assess the overall performance of the Medtronic Hugo™ RAS System when used for urologic robotic 
surgery. 
 
 

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5.1.3 Primary Endpoints 
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. 
The primary safety endpoint is the rate of subjects with complications meeting Grade III criteria or 
higher per the Clavien-Dindo Classification system1 from the first incision through 30 days post-
procedure. 
5.1.4 Secondary Endpoints 
Secondary objectives include descriptive analyses of secondary endpoints. 
The following safety and performance data shall be collected through 30 days post-procedure to assess 
the overall safety and performance of the Medtronic Hugo™ RAS System when used for urologic RAS: 
• 
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 
• 
Operative time 
• 
Intraoperative estimated blood loss (mL) 
• 
Transfusion rate 
• 
Rate of device-related conversion 
• 
Hospital length of stay 
• 
Readmission rate (through 30 days) 
• 
Reoperation rate (through 30 days) 
• 
Mortality rate (through 30 days) 
• 
Rate of device deficiencies 
The following long-term secondary endpoints will be assessed through 5 years in oncologic subjects: 
• 
Overall survival 
• 
Progression-free survival 
• 
Disease-free survival 
Performance Goals for Secondary Endpoints 
The details are summarized in the table found in Section 14.5. 
 
5.1.5 Other Prespecified Outcomes Measures 
Descriptive analyses of other pre-specified outcome measures beyond the primary and secondary 
objectives will be exploratory in nature and are not intended as a focus of the study for the evaluation of 
the study device. 

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The following will be collected as applicable: 
• 
Rate of positive surgical margins 
• 
Lymph node yield 
• 
Warm ischemia time 
• 
Surgeon experience 
 
6. Study Design 
A prospective, multicenter, single-arm pivotal study will be performed in up to 141 subjects undergoing 
a urologic RAS procedure using the Medtronic Hugo™ RAS System. Subjects without an oncologic 
indication will be followed for 30 days (+7 days) post procedure. Oncologic subjects will be followed 
through 5 years. This study will be conducted using up to six investigative sites in the United States of 
America (USA).  
This study will have two phases, a roll-in phase and an open enrollment phase. 
 
6.1 Roll-in Phase 
Two (2) sites will consecutively enroll a total of 15 subjects who will be treated with the Hugo™ RAS 
System as “roll-in cases”. These subjects will undergo the same preoperative and postoperative 
assessments (with the same schedule) as subjects who are enrolled in the open enrollment phase. 
Outcomes through 30 days for the first 15 roll-in cases will be provided in a summarized fashion and 
provided to the FDA for initial review without statistical inferences. The roll-in subjects will be included 
in the primary analysis with the open enrollment subjects and for all required reports. 
6.2 Open Enrollment Phase 
Following completion of the roll-in phase and sponsor approval, all sites will be allowed to enroll 
subjects in the study. During the open enrollment phase, all subjects enrolled will follow the Clinical 
Investigation Plan. 
 
6.3 Duration 
The expected study duration is approximately 5 years. The duration of individual subject participation 
will be approximately 67 days (30 to 30+7) for non-oncologic subjects and 5 years for oncological 
subjects. 
 
6.4 Rationale 
6.4.1 
Justification for the Clinical Evaluation 
Extensive pre-clinical testing has been performed to justify the use of the Hugo™ RAS System in humans.

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randomized study in a total of up to 141 subjects indicated for radical prostatectomy, radical 
cystectomy, or nephrectomy (partial or radical) surgical procedures. 
For version 8.0 of this protocol, an updated systematic literature search was conducted between June 1, 
2018 – 4 Jun 13, 2023 to identify published clinical data on the use of RAS for urologic surgery 
(nephrectomy, prostatectomy, and cystectomy). The databases searched were Medline, Embase and 
Journals@Ovid Full Text. The population was adult (non-pediatric) subjects. Version 9.0 was updated 
based on the qualitative review of the literature.  
A total of 130 articles were used to establish the study design (safety and effectiveness endpoints, 
performance goals, sample size, and follow-up timeframes). The full bibliography of all 130 publications 
supporting the updated primary and secondary endpoint performance goals is included in Section 17.1. 
The safety endpoint (30-day major complication rate) and effectiveness endpoint (surgical success rate) 
are described below: 
 
Safety: 
Critical appraisal of the information collected in the literature review established a 30-day major 
complication rate (Clavien-Dindo Grade III or higher) in order to assess the safety of the Hugo™ RAS 
System. 
Major Complication Primary Endpoint: The rate of subjects with major complications (usually 
defined as Clavien-Dindo Grade ≥ III) is a more commonly reported and clinically relevant 
measure than overall complications. The Expand URO study is designed to evaluate the three most 
complex and highest volume urology procedures.4 However, the procedural complexity, patient 
profile, and overall complication rates vary across the three procedure types. In the literature 
review, the overall complication rates varied from 0.2% (Hennessey 2018) to 53.3% (Abdul-
Muhsin 2020) for radical nephrectomy and 0.5% (Covas Moschovas 2022) to 50% (Gaboardi 2019) 
for radical prostatectomy versus 1.4% (Tamhankar 2020) to 76% (Jeglinschi 2020) for radical 
cystectomy. Cystectomy procedures carry a particularly high risk of anticipated low-grade 
complications due to patient age and comorbidity. Therefore, the rate of overall complications 
may not be a clinically meaningful evaluation of device safety for radical cystectomy.  Major 
complication rates range from 0.7% (Boga Long-term 2021) to 13.3% (Abdul- Muhsin 2020) for 
nephrectomy, 0.4% (Bahouth 2022) to 11.7% (Wilson 2020), versus 0.3% (Piazza 2022) to 19.7% 
(Arora 2020) for radical cystectomy in the literature review.  
The primary endpoint for the Expand URO study is the 30-day rate of subjects with major 
complications (Clavien-Dindo Grade ≥III). The overall rate of subjects with any complications 
(Clavien-Dindo Grade ≥I) will be captured and reported as a secondary endpoint. 
 

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Other commonly reported safety measures (e.g., blood loss, transfusions, conversions, length of 
stay, reoperation, and readmission rates) will be also captured and reported to provide a 
comprehensive assessment of device safety. 
• 
Sample Size and Enrollment Proportions: The sample size and performance goal estimates 
were derived from the literature search. The statistical design is therefore based on review of 
published data. A performance goal is specified for each of the three procedures. Additional 
details are provided in Section 14. 
• 
Follow-up Timeframe: Based on the preponderance of data in the literature search, a 30-day 
primary endpoint was chosen for safety reporting. Oncologic subjects will be followed for 5 
years. 
 
Effectiveness: 
Critical appraisal of the information collected in the literature review established the surgical success 
rate in order to assess the effectiveness of the Hugo™ RAS System. 
• 
Surgical Success Primary Endpoint: 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. 
• Sample size and enrollment proportions: The effectiveness endpoint sample size of up to 141, 
is based on the rationale of an acceptable surgical success rate of 90% or higher, a power of 
80% or higher, and a performance goal of 85%.  
 
The hypothesis will be tested using the Clopper-Pearson exact method at one-sided alpha of 0.025. 
• 
Follow-up timeframe: Surgical success will be assessed at the index procedure. 
 
Additional specific design justifications were also considered while developing this clinical investigation 
of the intended use. 
 
• 
Subject Selection: Excluding subjects with high-risk comorbidities affecting their surgical 
eligibility will minimize the risk to subjects. Restricting enrollment to subjects with a life 
expectancy of 6 months or more is intended to provide a greater follow-up rate on the primary 
endpoint. 
• 
Study Procedures: The study procedures chosen (partial or radical nephrectomy, radical 
prostatectomy, and radical cystectomy) are representative, in terms of technical difficulty, of 
 

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surgeon console track the movement of the 3D glasses worn by the surgeon and can clutch movement 
of the instruments if the surgeon looks away from the 3D display. The surgeon hand controllers are easy 
to move and respond to wrist movement. 
7.1.2 
Hugo™ RAS Arm Cart Assembly 
The arm carts consist of movable platforms with casters, each supporting a modular and extendable 
arm. Up to four arm carts can be connected to the system tower for simultaneous use during RAS. The 
arm carts are portable and easily movable within the operating room and the hospital. Prior to surgery, 
the OR team positions the arm carts around the surgical table according to the surgical procedure. The 
team can adjust the arm carts and arms to accommodate subject positioning and optimize bedside 
access to the subject. 
 
7.1.3 
Hugo™ RAS Tower, 120v 
The system tower houses computers, the endoscope system, the electrosurgical generator, the power 
management system with a backup battery, and the high-definition OR team touchscreen interactive 
display. The system tower allows the surgeon console to control the movements of up to four arms. It 
may also be used without the surgeon console to power up to four arms for standalone manual control 
at the bedside, or by itself for standard laparoscopic visualization and electrosurgery. 
7.1.4 
Hugo™ RAS Endoscope Adapter 
The Hugo™ RAS endoscope adapter is intended to hold the compatible Karl Storz TIPCAM ®1 S 3D 
endoscope used with the Medtronic Hugo™ RAS System. The endoscope adapter will be attached to the 
robotic arm for the Medtronic Hugo™ RAS System during the representative surgical procedures set 
forth in the Medtronic Hugo™ RAS System user guide. 
 
7.1.5 
Hugo™ RAS Sterile Interface Module 
The Hugo™ RAS sterile interface module device is intended to be used with the Hugo™ RAS system as a 
universal connection on the robotic arm for the Hugo™ RAS sterile instruments and endoscope adapter 
during the representative surgical procedures set forth in the Hugo™ RAS system user guide. 
 
7.1.6 
Hugo™ RAS Arm Cart Sterile Drapes 
The Hugo™ RAS Arm Cart Sterile Drape is a single use, sterile drape that is designed as part of the Hugo™ 
RAS System. There are three types of sterile drapes, and each is designed to cover a different non-sterile 
section of the Hugo™ RAS Arm Cart. The Arm Cart Sterile Drape covers the non-sterile robotic arm, or 
upper part of the arm cart, or lower part of the arm cart of the Hugo™ RAS System in order to allow the 
system to be used within the sterile field. 
For Hugo™ RAS System configuration information, Instructions for Use, indications, contraindications, 
warnings, and precautions, refer to the User Guide for the Hugo™ RAS System. 
 

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The product is to be used by medical professionals qualified in the transportation, preparation, and use 
of surgical devices. The Hugo™ RAS System is intended for use in a sterile operating room environment. 
 
7.1.7 
Wristed Instruments 
The Hugo™ RAS system’s wristed instruments are minimally invasive instruments that provide two 
degrees of freedom (pitch, yaw) at the distal end of the instrument in addition to the opening and 
closing of the instrument jaws. These degrees of freedom, when commanded from the surgeon console, 
allow for precise and dexterous control of the instrument by the surgeon. Hugo™ RAS system 
configuration information, Instructions for Use, indications, contraindications, warnings, and 
precautions, refer to the Hugo™ RAS system user guide. 
These products are to be used by medical professionals qualified in the transportation, preparation, and 
use of surgical devices.  
The Hugo™ RAS system is intended for use in a sterile operating room environment. 
 
 
7.1.7.1 Hugo™ RAS Monopolar Curved Shears 
The Hugo™ RAS Monopolar Curved Shears is a Hugo™ RAS wristed instrument with a sharp curved 
cutting-blade end effector for tissue manipulation including blunt dissection, sharp dissection, 
electrocautery and cutting. The Hugo™ RAS monopolar tip cover is required when using the Hugo™ RAS 
monopolar curved shears. 
 
7.1.7.2 Hugo™ RAS Monopolar Tip Cover 
Monopolar shears are used to cut and cauterize tissue, however only the jaws should be energized. A tip 
cover is installed over the distal end of the instrument to prevent other metallic parts of the distal end 
from conducting electricity. This cover should be checked for structural integrity after every instrument 
extraction to prevent unintended burns to the subject as outlined in the Instructions for Use. 
 
7.1.7.3 Hugo™ RAS Bipolar Fenestrated Grasper 
The Hugo™ RAS Bipolar Fenestrated Grasper is a Hugo™ RAS wristed instrument with a fenestrated jaw 
end effector for tissue manipulation including grasping, blunt dissection, approximation, electrocautery, 
and suturing. 
 
7.1.7.4 Hugo™ RAS Bipolar Maryland Forceps 
The Hugo™ RAS Bipolar Maryland Forceps is a Hugo™ RAS wristed instrument with a curved tapered jaw 
end effector with fenestration at the base of the jaw for tissue manipulation including grasping, blunt 
dissection, approximation, electrocautery, and suturing. 

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7.1.7.5 Hugo™ RAS Large Needle Driver 
The Hugo™ RAS Large Needle Driver is a Hugo™ RAS wristed instrument with an end effector designed 
to hold and drive large needles. 
 
7.1.7.6 Hugo™ RAS Extra Large Needle Driver 
The Hugo™ RAS Extra Large Needle Driver is a Hugo™ RAS wristed instrument with an end effector 
designed to hold and drive large needles. 
 
7.1.7.7 Hugo™ RAS Cadiere Forceps 
The Hugo™ RAS Cadiere Forceps is a Hugo™ RAS wristed instrument with a rounded, wide fenestrated 
jaw end effector for tissue manipulation including grasping, blunt dissection, approximation, and 
suturing. 
 
7.1.7.8 Hugo™ RAS Double Fenestrated Grasper 
The Hugo™ RAS Double Fenestrated Grasper is a Hugo™ RAS wristed instrument with a long fenestrated 
jaw end effector for tissue manipulation including grasping, blunt dissection, approximation, and 
suturing. 
 
7.1.7.9 Hugo™ RAS Toothed Grasper 
The Hugo™ RAS Toothed Grasper is a Hugo™ RAS wristed instrument with a toothed claw grasper end 
effector for tissue manipulation including grasping and approximation. 
 
7.1.8 
Software 
Software versions will be captured in shipment records, including the clinical shipment/return form. 
 
7.2 Manufacturer 
Please see Table 3 and Table 4. 
 
7.3 Packaging 
The Medtronic Hugo™ RAS System components and instruments will be labelled as investigational 
according to regulations, such as: “CAUTION – Investigational device. Limited by Federal (or United 
States) law to investigational use”. 
 
7.4 Intended Population 
The target population will consist of subjects 22 years of age or older indicated for a urological robotic 
assisted surgery with Hugo™ RAS. 
 
 

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Other Equipment: 
The following components may be required for the study procedures and will not be provided by the 
study sponsor. 
• Energy Sealing Device 
• Linear Stapler 
• Reticulating Stapler 
• Surgical Clips 
7.6 Product Use 
This information is contained in the IFU (Appendix 18.3). The IFU accompanying the device 
should always be consulted. 
The device will be in contact with the urologic region including tissues and body fluids. All device 
components and materials are biocompatible. Device biocompatibility testing and results are 
summarized in the Report of Prior Investigations (Appendix 18.2). 
For instructions on study product scope of use and handling, please refer to the IFU (Appendix 18.3). 
 
7.7 Product Training Materials 
See Table 5. The Medtronic Hugo™ RAS System should only be used by surgeons and OR staff who have 
received specific product training provided by Medtronic in the use of this device. The training provided 
by Medtronic does not replace the necessary medical training and experience required to perform 
surgery. 
Surgeons and hospital staff performing study procedures will be required to demonstrate a minimum 
level of professional competency and product training outlined below prior to performing study 
procedures. 
 
Technical Training focus areas include: 
• 
Hugo™ System Operation 
• 
Hugo™ System Surgical Field Set-up 
• 
Hugo™ System Console Skills 
• 
Hugo™ System Clinical Application 
• 
RAS Fundamental Surgical Task Skills 
 
 
 
 
 

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Study devices should be kept in or otherwise contained where only qualified study personnel can access 
the device (i.e., locked or secured). This area/container should be kept at ambient temperatures without 
exposure to water with adequate provisions for maintaining ambient temperatures if a loss of power is 
experienced. If the devices are exposed to water or a drastic change in temperature, sites should 
contact the study team for possible replacement devices. 
 
7.10 Product Return 
It is the responsibility of the site to return the Medtronic Hugo™ RAS System to Medtronic at the end of 
the study, along with any unused or expired Medtronic Hugo™ RAS wristed instruments or other 
components. Sites should follow instructions and complete all appropriate forms provided by the study 
team for product return. 
7.11 Product Accountability 
Access should be limited to designated study staff only. A device accountability log will be maintained at 
the site and reconciled by the end of the study. It is the site’s responsibility to document the receipt 
(which includes shipping/dispersal date, the quantity, model, lot, and serial numbers, and expiration 
date), disposition of the product (per subject use, including amount used, amount remaining, etc.), 
transfer (if applicable), and return of all unopened investigational medical devices at the end of the 
study. The sponsor shall also keep records to document the physical location of all investigational 
devices from shipment of investigational devices to the investigation sites until return or disposal. 
 
Medtronic will perform periodic reconciliation of the investigational product to ensure traceability 
through monitoring. 
 
8. Study Site Requirements 
8.1 Investigator/Investigation Site Selection 
All Investigators managing the subject’s urologic condition must be qualified practitioners and 
experienced in the diagnosis and treatment of subjects with study specific urologic conditions. All 
physicians must be experienced and/or trained in the handling of the Medtronic Hugo™ RAS System. 
The role of the Principal Investigator is to implement and manage the day-to-day conduct of the clinical 
investigation as well as ensure data integrity and the rights, safety and well-being of the subjects 
involved in the clinical investigation. 
The Principal Investigator shall: 
• 
Be qualified by education, training, and experience to assume responsibility for the proper 
conduct of the clinical investigation 
• 
Be experienced in the field of application and training in the use of Medtronic Hugo™ RAS 

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System. 
• 
Disclose potential conflicts of interest, including financial, that interfere with the conduct of the 
clinical investigation or interpretation of results 
• 
Be able to demonstrate that the proposed investigational study site: 
o Has the required number of eligible subjects needed within the recruitment period 
o Has one or more qualified Investigators, a qualified investigational study site team and 
adequate facilities for the foreseen duration of the clinical investigation 
Study site personnel training will be completed and documented prior to participation in this study. 
 
8.2 Study Site Activation 
During the activation process (prior to subject enrollment), Medtronic will train study site personnel on 
the clinical investigation plan, on relevant standards and regulations, informed consent, and on data 
collection and reporting tools. If new members join the study site team, they will receive training on the 
applicable study requirements relevant to their role before contributing to the study. 
Prior to performing study related activities, all regulatory requirements shall be fulfilled, including, but 
not limited to the following: 
• 
Institutional review board (IRB) approval (and voting list, as required by local law) of the current 
version of the clinical investigation plan (CIP) and informed consent (IC) 
• 
Regulatory authority (RA) approval or notification (as required per local law) 
• 
Fully executed clinical trial agreement (CTA) 
• 
Financial disclosure (if applicable) 
• 
Curriculum vitae (CV) of Investigators and key members of the investigation study site team (as 
required). The signature on the CV must be dated within 3 years prior to the date of activation 
of the study site. 
• 
Documentation of delegated tasks 
• 
Documentation of study training 
• 
Additional requirements imposed by local regulations, the IRB and RA shall be followed, if 
appropriate 
In addition, all participating study site staff must be trained on the current version of the CIP as well as 
on the applicable study requirements depending on their role and must be delegated by the Principal 
Investigator to perform study related activities. 
Medtronic will provide each study site with documentation of study site/Investigator readiness; this 
letter must be received prior to performing study related activities. 
 
 

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8.3 Role of the Sponsor Representatives 
Sponsor representatives may provide support at the study site as required for the study under 
supervision of the Principal Investigator, including: 
• 
Provide study training relevant and pertinent to the involvement of personnel conducting study 
activities and Investigator responsibilities 
• 
Technical support will be provided during the procedure under the supervision of a study 
Investigator, but no data entry, shall be performed by Medtronic personnel or their 
representatives at study sites 
• 
Monitoring and auditing activities 
In addition, for this study, sponsor representatives may be authorized by the Principal Investigator to 
perform the following significant trial related duties: 
• 
Support study Investigators in performing the study procedure 
• 
Support data collection during the procedure and device testing 
• 
Support data collection during the study follow-up visits. Any data collection completed by 
Medtronic personnel will be clearly identified as such. 
 
9. Selection of Subjects 
9.1 Study Population 
A minimum of 141 subjects will be enrolled at up to 6 sites in the USA. 
The Medtronic Hugo™ RAS System is intended to be used in this study for urologic surgical procedures 
including radical prostatectomy, radical cystectomy, nephrectomy (partial or radical) procedures to be 
performed in subjects that meet the inclusion criteria listed in Section 9.3. 
Subject conditions and/or diagnoses may include, but are not limited to, prostate cancer, pelvic tumors, 
interstitial cystitis, congenital abnormalities, end-stage kidney disease (kidney failure), renal tumor, 
kidney injury. 
The subjects must be acceptable candidates for a fully robotic assisted procedure with the Medtronic 
Hugo™ RAS System, as determined by the investigating surgeon. 
 
9.2 Subject Enrollment 
A subject is considered enrolled in the study when the consent process is signed and dated. Screening 
data will not be collected for the study until the subject has been determined to be eligible for the study 
and signed consent (see Section 10.2 for details). If the subject is consented prior to the day of surgery, 
a re-verification of eligibility will be signed off by the PI or Sub-I on the day of surgery. As soon as the 
surgical procedure has begun with the Medtronic Hugo™ RAS System, the subject must be followed  

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regardless of whether or not the subject completed the surgical procedure with the Medtronic Hugo™ 
RAS System. Subject enrollment will be consecutive at the institution according to required procedure 
types and eligibility criteria. See Section 9.3 for additional details. 
 
9.3 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 signed informed 
consent form 
 
9.4 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. The patient has been 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 thirty (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 
 
 
10. Study Procedures 
10.1 Schedule of Events 
10.1.1 
Screening Visit (Visit 1) 
A screening visit will be performed within 30 days prior to the scheduled procedure and may be  

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combined with the surgical procedure visit. Subjects will be consented before any procedures specific to 
the study are undertaken. If the subject is consented prior to the day of surgery, a re-verification of 
eligibility will be signed off by the PI or Sub-I on the day of surgery. The purpose and all aspects of the 
study will be explained to the subject. Subjects who agree to study participation must sign and 
personally date an IRB-approved informed consent form prior to participating in any study activities. 
Once informed consent has been obtained according to IRB requirements and eligibility is confirmed, 
the subject’s demographics and medical history will be assessed. Relevant medical and surgical history 
will be assessed and included in the electronic case report form (eCRF). 
 
10.1.2 
Surgical Procedure Visit (Visit 2) 
The subject will arrive for admission to the hospital, will be checked in, placed in pre-op, and prepped 
for surgery according to local standard practices. Upon arrival to the operating room the subject will be 
placed on the plinth, the anesthesia and surgical teams will place the subject in position and the 
operation will begin at the time of the first incision. The study Investigator should perform the surgical 
procedure according to the appropriate standard of procedures, practices, and set-up guidelines. See Table 6      
for the data that will be collected during this procedure. 
 
10.1.3 
Up to Hospital Discharge (Visit 2.1) 
Visit 2.1 will begin when the subject arrives in recovery after the operation is over and will last through 
the subject being discharged from the hospital. All standard-of-care practices will be followed for this 
visit. See Table 6 for the data that will be collected during this procedure. 
 
10.1.4 
Post-Operative Follow-Up Visit (Visit 3) 
The 30 (+7) days post-operative visit should be made by an in-person follow-up visit to the site. 
Only in extreme circumstances (i.e., COVID-related in person restrictions at the site, difficulties of the 
subject travelling to the site), the 30 (+7) day follow-up visit may be conducted via phone call and/or 
video conference for the collection of adverse event and medical follow-up information. 
 
10.1.5 
Post-Operative Follow-Up Visits (Visit 4-8) 
Post-operative visits 4-8 for oncologic subjects will be made via a phone call to assess overall survival, 
progression-free survival, and disease-free survival. 

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10.3 Prior and Concomitant Medications/Therapies 
Institutional standard of care (SoC) pre-operative protocols and guidelines are typically in place to 
manage medications and are not reportable for the purposes of this study. Follow the guidelines below 
to report medications relevant to this study: 
• Report applicable pre-procedure medications if taken within 30 days of the study procedure as listed 
below 
• Pain medication(s) must be reported if given when pain (Clavien-Dindo Grade I or higher – pain 
exceeds that which is considered within normal limits) is reported as an adverse event (AE) 
• Medications given during the procedure and/or post-procedure as treatment or preventative that 
result in reportable AE should be captured 
• Please reference # 3 of the I/E for clarification 
 
For study purposes, reporting of the following drugs are required to evaluate potential adverse events 
and endpoints. 
 
10.3.1 
Anticoagulants Taken within 30 Days Prior to Surgery 
 
Prescription anticoagulants may include: 
• warfarin (Coumadin) 
• enoxaparin (Lovenox) 
• clopidogrel (Plavix) 
• ticlopidine (Ticlid) 
• aspirin (in many versions) 
• non-steroidal anti-inflammatory (NSAIDs) (in many versions) 
• dipyridamole (Persantine) 
 
Non-prescription (over-the counter or herbal) anticoagulants may include: 
• non-steroidal anti-inflammatory (NSAIDs) (in many versions) 
• Vitamin E 
• Garlic 
• Ginger 
• Ginkgo biloba 
 
 
 

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10.3.2 
Monoamine Oxidase Inhibitors (MAOIs) Taken within 30 days 
Prior to Surgery 
 
MAOIs may include: 
• tranylcypromine (Parnate, Sicoton) 
• phenelzine (Nardil, Nardelzine) 
• isocarbonazid (Marplan) 
• rasagiline (Azilect) 
• selegiline (Eldepryl, Deprenyl) 
• linezolid (Zuvox) (an antibiotic) 
• St. John’s Wort 
 
In addition to the above, any medication given as a result of a study reported adverse event will be 
reported. Exclude the reporting of antiemetics, antipyretics, analgesics, diuretics and electrolytes and 
physiotherapy when given per standard of care procedures and/or within normal limits (dosage and 
frequency). 
 
10.4 Subject Consent 
Informed consent (IC) is defined as a legally effective documented confirmation of a subject’s voluntary 
agreement to participate in a particular study after information has been given and explained to the 
subject on all aspects of the study that are relevant to the subject’s decision to participate. This process 
includes obtaining an IC form that has been approved by the study site’s IRB and signed and dated by 
the subject. A subject may only consent after information has been given and explained to the subject 
on all aspects of the clinical investigation that are relevant to the subject’s decision to participate. 
Prior to enrolling subjects, the IC site must be approved by the IRB. The document(s) must be controlled 
(i.e., versioned and/or dated) to ensure it is clear which version(s) were approved by the IRB. Any 
adaptation of the sample IC must be reviewed and approved by Medtronic and the IRB reviewing the 
application prior to enrolling subjects. 
The Investigator must notify the subject of any significant new findings about the study that become 
available during the course of the study which are pertinent to the safety and well-being of the subject, 
as this could impact a subject’s willingness to participate in the study. If relevant, consent may be 
requested from subjects to confirm their continued participation. 
Subjects will be informed that despite signing informed consent, the screening assessment may 
demonstrate the subject is not a suitable candidate for the study or the procedure and may be 
withdrawn. Subjects will also be informed that after the investigation visits are completed, the subjects 
will receive the standard medical care, just as they would have had they not participated in the study. 

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Prior to initiation of any study-specific procedures, IC must be obtained from the subject. The informed 
consent form must be personally signed and dated by the subject themselves and Investigator or the 
Investigators designee at the time of consent. Likewise, privacy or health information protection 
regulation may require subjects to sign additional forms to authorize study sites to submit subject 
information to the study sponsor. 
The IC process must be conducted by the Principal Investigator or an authorized designee, and the IC 
Form must be given to the subject in a language he/she is able to read and understand. The process of 
IC must be conducted without using coercion or undue improper influence on or inducement of the 
subject to participate by the Investigator or other study site personnel. The IC process shall not waive or 
appear to waive subject’s legal right. The language used shall be as non-technical as possible and must 
be understandable to the subject. 
The subject must have ample time and opportunity to read and understand the IC form, to inquire 
about details of the study, and to decide whether or not to participate in the study. All questions about 
the study should be answered to the satisfaction of the subject. 
When the subject decides to participate in the study, the IC must be signed and personally dated by the 
subject and Investigator or authorized designee, as required by the IC, and ensured by the Principal 
Investigator or his/her authorized designee. 
A copy of the IC signed and dated as required by law, must be provided to the subject. 
If the IC is obtained the same day the subject begins participating in study-related procedures, it must 
be documented in the subject’s case history that consent was obtained prior to participation in any 
study-related procedures. It is best practice for the IC process to be documented in the subject’s case 
history, regardless of circumstance. 
10.5 Assessment of Performance 
The secondary endpoints of this study (operative time, device-related conversions, device deficiencies) 
will assess the overall performance of the Medtronic Hugo™ RAS System when used for urologic robotic 
surgery. Secondary endpoints will evaluate the safety and performance of the study device and will not 
evaluate specific label claims. 
10.6 Assessment of Safety 
Safety will be evaluated through the study primary endpoint (major complications) and several 
secondary endpoints (Section 5.1.4). 
Safety will also be assessed by monitoring the occurrence of adverse events (AEs), serious adverse 
events (SAEs), deaths, adverse device effects (ADE), serious adverse device effects (SADE), unanticipated 
adverse device effects (UADE) or device deficiencies. Adverse event assessments will take place starting 
with the point of consent, through the end of study exit through 5-year follow-up, or until resolution 
whichever comes first and will be recorded in the eCRF. 

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AEs will be collected from the time of consent. AEs occurring in subjects excluded from the full analysis 
set (FAS) (Section 14.1) will be followed post-consent through study exit and will be reported in a listing 
in the clinical study report (CSR).  
These AEs will not be included in the FAS summary analysis for either AE reporting or the analysis of the 
primary and secondary endpoints. 
For the FAS, the type, incidence, severity, duration, and procedure/device relatedness of AEs will be 
reported. AEs for all FAS subjects will be analyzed from first incision through the study exit. 
 
10.7 Recording Data 
Data entered must be traceable to source documents. Source documentation is defined as the first-time 
data appear, and may include original documents, data, and records (e.g., hospital records, clinical and 
office charts, procedure reports, laboratory notes). 
In general, eCRFs (or paper copies) may not serve as source documents. Source documentation for data 
elements not routinely captured in medical records may vary from study site to study site; the study site 
may use source document worksheets if identified as source documents. 
The Investigator must ensure the availability of source documents from which the information on the 
eCRFs was derived. The type and location of source documents should be documented. Where printouts 
of electronic medical records, are provided as source documents, or where copies of source documents 
are retained as source documents, those should be certified. Certification must contain (1) the signature 
of the individual making the copy and (2) the date the copy was made. 
The source documents must be made available for monitoring or auditing by Medtronic’s representative 
or representatives of the competent authorities and other applicable regulatory agencies. 
The CRF may be considered source for the following data collection elements: 
• 
Enrollment Notification 
• 
Study site assigned subject reference 
 
• 
Baseline 
• 
Administrative information 
• 
AE eCRF 
• 
Date study site became aware of event 
• 
Relatedness of adverse event 
• 
DD eCRF 
• 
Date study site became aware of event 
 

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• 
Subject Death 
• 
Date study site became aware of death 
• 
Relatedness of death 
• 
Deviations 
• 
Reason for deviation 
10.8 Deviation Handling 
A study deviation is defined as an event within a study that did not occur according to the CIP or the 
CTA. 
Prior approval by Medtronic is expected in situations where the Investigator anticipates, contemplates, 
or makes a conscious decision to deviate. Prior approval is not required when a deviation is necessary to 
protect the safety, rights, or well-being of a subject in an emergency or in unforeseen situations beyond 
the Investigator’s control (e.g., subject failure to attend scheduled follow-up visits, inadvertent loss of 
data due to computer malfunction, inability to perform required procedures due to subject illness). 
For medically justifiable conditions which preempt a subject’s ability to complete a study-required 
procedure, it may be permitted to report only one deviation which will apply to all visits going forward. 
This may also apply for other unforeseen situations (e.g., the subject permanently refuses to complete a 
study required procedure and the data will not contribute to the primary end point analysis). However, 
prior approval from Medtronic is required for such situations. 
All study deviations must be reported on the CRF regardless of whether medically justifiable, pre- 
approved by Medtronic, an inadvertent occurrence, or taken to protect the subject in an emergency. 
Multiple deviations of the same type at the same visit may be reported on one case report form. 
In the event the deviation involves a failure to obtain a subject’s consent or is made to protect the life or 
physical well-being of a subject in an emergency, the deviation must be reported to the IRB as well as 
Medtronic within five (5) working days. Reporting of all other study deviations should comply with IRB 
policies and/or local laws and must be reported to Medtronic as soon as possible upon the study site 
becoming aware of the deviation. Reporting of deviations must comply with IRB policies, local laws, 
and/or RA requirements. 
Medtronic is responsible for analyzing deviations, assessing their significance, and identifying any 
additional corrective and/or preventive actions (e.g., amend the CIP, conduct additional training, 
terminate the investigation). Repetitive or serious Investigator compliance issues may result in initiation 
of a corrective action plan with the Investigator and study site, and in some cases, may necessitate 
suspending enrollment until the problem is resolved or ultimately terminating the Investigator's 
participation in the study. Medtronic will provide study site-specific reports to Investigators 
summarizing information on deviations that occurred at the investigational study site on a periodic 
basis. 

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If during the procedure, the Investigator changes from HUGOTM to another RAS system (even if it is in 
conjunction with HUGOTM), it will no longer be a protocol deviation, but it will be captured as a device 
deficiency as needed/applicable. If the Investigator converts to laparoscopic or open surgery, it will not 
be considered a protocol deviation. 
Examples of study deviations include but are not limited to: 
• 
Failure to obtain proper IC 
• 
Failure to collect required study data 
• 
Inclusion/exclusion criteria not met 
10.9 Subject Exit, Withdrawal or Discontinuation 
Subjects may voluntarily withdraw from the study at any time. Additionally, the Principal Investigators 
may withdraw or choose not to enroll subjects if they feel they do not meet the CIP defined inclusion 
and exclusion criteria or if it is in the best medical interest of the subject in question. If the study 
Investigator voluntarily removes a subject from further study participation, supporting documentation 
must be in place for the rationale and date of removal. 
Every attempt will be made to contact subjects who are noncompliant. Subjects will be considered lost 
to follow-up once the following steps have been taken: 
• 
Three phone calls should be made to the subject. Each attempt should be clearly documented in 
the source documents and the response or lack thereof should be captured. 
• 
If there is no response to the phone calls, then a certified/registered letter should be written to 
the subject. A copy of the letter should be retained in the subject’s source document. 
• 
After a period of two weeks following completion of the above actions, the subject will be 
considered lost to follow-up. The sponsor should be notified and the Study Exit form should be 
completed. 
In cases of early study exits, all data collected from the time of informed consent to the time of exit may 
be used. Subjects who exited early will not be replaced. Enrollment will continue as per CIP definitions 
up to the predefined maximum number of subjects. 
The reason and date for study exit of all enrolled subjects will be documented on the applicable 
electronic case report form (eCRF). 
All subjects will be followed per institutional standard of care after any withdrawal, discontinuation, or 
completion of the study follow-ups. 
 
10.9.1 
Study Exit 
A study exit eCRF is required for all subjects. Prior to exiting a subject from the study, it is recommended 
 

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to follow the subject until all ongoing system and/or procedure related AEs are resolved or unresolved 
with no further actions planned.  
Following exit, subjects will continue to receive standard medical care. Upon exiting from the study, no 
further study data will be collected, or study visits will occur for the subject. All data available through 
the time of the subject’s exit will be used for analysis. 
Subjects are urged to remain in the study as long as possible but may be exited from the study for any of 
the following situations: 
• 
Study completed 
• 
Subject lost to follow-up 
• 
Subject death 
• 
Subject did not meet inclusion/exclusion criteria 
• 
Subject did not provide consent (or data use protection authorization) 
• 
Subject chooses to withdraw (e.g., consent withdrawal, relocation to another geographic 
location) 
• 
Investigator deems withdrawal necessary (e.g., medically justified, inclusion/exclusion criteria 
not met, failure of subject to maintain adequate study compliance) 
The following information is required to be collected at study exit: 
• 
Reason for exit 
 
If discontinuation is because of safety or lack of effectiveness, the subject shall be asked to be followed 
for collecting safety data outside the clinical investigation. 
10.9.2 
Study Completed 
At the completion of the 30 (+7) day follow-up visit, non-oncologic subjects will be exited from the 
study. At the completion of the 5-year follow-up visit, oncologic subjects will be exited from the study. 
The 30 (+7) day or the 5-year follow-up visit and exit visit should be combined, and either the 30 (+7) or 
the 5-year follow-up eCRF and the Study Exit eCRF need to be completed. 
 
10.9.3 
Lost to Follow-up 
A subject is considered to be lost to follow-up if the conditions in section 10.9 are met. The method of 
attempt must be documented in the subject’s medical record. In addition, regulation set forth by the 
governing IRB must be followed. 
When subjects are lost to follow-up the Investigator will make efforts to confirm the vital status of the 
subject, as described in the informed consent. 
 

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10.9.4 
Subject Chooses to Exit (i.e., Revokes Consent) 
A subject can withdraw from the study at any time. If the subject wishes to exit from the study (i.e., the 
subject revokes consent), the study site is required to document the reason for exit on the Study Exit 
eCRF. In addition, study sites shall follow the regulations set forth by the governing IRB. If possible, the 
following data should be collected prior to subject withdrawal: 
• 
Reason for exit 
10.9.5 
Investigator Withdraws Subject 
No subjects should be withdrawn by Investigators unless compelling medical justification is present. It is 
recommended investigators discuss any withdrawals with the study team prior to withdrawing subjects. 
If an Investigator withdrawal is necessary, the following data should be collected prior to subject 
withdrawal if possible: 
• 
Reason for subject withdrawal 
10.9.6 
Conditional Disengagement 
After a subject is enrolled every effort should be made to keep the subject in the study. However, it is 
recognized that there are circumstances where limited data may be collected, or study exit will need to 
occur. In these cases, we will consider either modified data collection requirements where subjects may 
conditionally disengage in study procedures but data from the subject can still be collected because the 
subject has not revoked consent or exit when study participation is completely ended. Modified data 
collection is always preferred over exit.  
Subjects may be conditionally disengaged from study procedures for any of the following reasons: 
• 
Subject chooses to disengage (e.g., follow-up schedule cannot be adhered to, study burden too 
large, relocation to another geographic location but telephone follow-up still acceptable) 
• 
Investigator deems conditional disengagement necessary (e.g., medically justified) 
If the subject wishes to disengage from the study, or the Investigator deems it necessary, the study site 
is required to document the reason. Data collection requirements no longer apply, but study sites are 
encouraged to collect as much data as possible on the regular eCRFs. 
 
 
11. Risks and Benefits 
11.1 Potential Risks 
Medtronic follows rigorous Quality Assurance and Control procedures throughout the life of a product, 
from the business analysis phase through development, market release, and post-market surveillance. 
 

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The Medtronic risk management process follows ISO 14971:2012, Medical Devices -- Application of Risk 
Management to Medical Devices and applicable requirements of YY/T 0316-2008 Medical devices— 
Application of risk management to medical devices (ISO 14971: 2007, IDT). 
The Risk Management Report (RE00308824) summarizes the risk management activities for the Hugo™ 
RAS System as stated in the Risk Management Plan (R0057077), as well as the overall acceptability of 
risk. The Risk Management Report addresses risks resulting from the interaction between the user, the 
subject, and the device. It does not focus on risks inherent to medical treatment enabled by the Hugo™ 
RAS System. This risk analysis assumes that the product shall only be operated by qualified, properly 
trained medical personnel. While every attempt has been made to reduce subject and user risks, all 
surgeries using Hugo™ RAS System carry some residual risk, even when used by trained physicians. 
Specific details of hazardous situations, causes, and risk control measures are identified in the Risk 
Analysis Chart (RE00027518). Hazardous situations as described in the Risk Management Plan, their 
associated harms, and specific device benefits to mitigate these hazardous situations are identified 
below. 
 
• 
Arrhythmia 
• 
Bleeding 
• 
Blunt Trauma 
• 
Bowel Perforation 
• 
Burn (varying Degrees) 
• 
Burn, Bowel 
• 
Burn, Thermal 
• 
Crushing Injury 
• 
Damage to equipment/facility 
• 
Delay of Treatment (Prolonged procedure) 
• 
Electric Shock 
• 
Foreign Body in Patient 
• 
Implant, Failure of 
• 
Infection 
• 
Inflammation 
• 
Tissue Damage/Tissue Trauma 
• 
Toxicity 
• 
Vessel Perforation 
 

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The incidence of these risks may be different than anticipated due to unknown circumstances or medical 
conditions. 
There may be other discomforts and risks related to the Hugo™ RAS System and/or this study that are 
not foreseen at this time. In addition, the Hugo™ RAS System for urological indications is investigational 
in the United States and may be no more or less safe or effective than other commercially available 
robotic surgery systems. 
The study sponsor may decide to stop the study before obtaining approval of the investigational product 
but will continue to guarantee subjects safety. 
 
11.2 Risk Minimization 
The potential risks associated with the Medtronic Hugo™ RAS System were identified and have been 
successfully mitigated in the risk management process described above. Medtronic has further 
minimized the possibility of risks by performing required laboratory and preclinical testing prior to 
this clinical study and implementing quality control measures into production processes. 
Any potential risks associated with participation in this study are further minimized by providing 
guidelines for subject selection and evaluation, providing adequate instructions and labeling, selecting 
qualified investigators, and training study personnel on the safe use of the device and on the CIP 
procedures. 
Medtronic has also attempted to minimize risk to subjects by using an independent Clinical Events 
Committee to review safety issues identified as part of the study. 
The potential risks associated with the Medtronic Hugo™ RAS System have been identified above and 
will be constantly monitored, assessed, and documented by the Investigators and sponsor. 
 
11.3 Potential Benefits 
The Hugo™ RAS System may offer no benefit. As with commercially available robotic surgery systems, 
the potential benefits of undergoing urologic surgery using the Hugo™ RAS System may include lower 
complication rates compared to traditional laparoscopic and open surgical procedures (Section 
6.4.1). 
As described in Section 6.4.1, the safety and performance of commercially available RAS systems have 
been evaluated in the literature search showing that robotic-assisted surgery was comparable or 
superior to open or traditional laparoscopic surgery in most comparisons. 
Other benefits listed below may more directly impact surgeon performance, although ultimately, they 
affect the end result of subject outcomes and thus are important safety and performance factors. 
• 
Better ergonomics and less strain or fatigue for the user. The torque forces are delegated to the 
robotic arms, which decreases the strain on surgeon’s muscles in the neck, shoulders, and back. 
 

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• 
Mitigation of hand tremors, which results in fewer surgeon errors 
• 
Better 3D visualization of surgical field for the console surgeon. The camera is controlled by the 
surgeon and not the assistant. The trainees see what the surgeon is seeing at the console, albeit 
in 2D rather than 3D. 
• 
Lack of fulcrum effect. This factor helps to shorten the learning curve for RAS use. 
• 
Shorter learning curve compared to traditional laparoscopic surgery. 
The data collected from this study will also help characterize the safety and performance of the Hugo™ 
RAS System. If the results of this study support additional clinical research, further studies may be 
justified to evaluate the potential for improved standard-of-care using robotic-assisted urologic surgery. 
This study does not exclude any adults based on age therefore this risk-benefit rationale should be 
generalizable to Medicare beneficiaries who qualify for a robotic-assisted urologic surgery. In literature, 
typical age ranges for the three included procedures are 52 to 70 years for partial nephrectomy,31 57 to 
67 years for radical prostatectomy,7 and 59 to 79 years for radical cystectomy.19 
11.4 Risk-Benefit Rationale 
As described in the Risk Management Report (RE00308824), use of the Hugo™ RAS System involves 
residual risk. The established controls provide adequate assurance that the identified potential risks 
described above have been eliminated, reduced to an acceptable level, or deemed acceptable. These 
controls will ensure that a consistently safe and effective product is produced for the intended user. 
In addition, preclinical, animal, and cadaver studies demonstrate that the Hugo™ RAS Platform performs 
as intended. Verification testing shows that the Hugo™ RAS Platform meets all product and system 
design input requirements. The clinical literature (Section 6.4.1) provides relevant subject experience for 
RAS. The safety and performance of commercially available RAS systems are supported by the 
observation that length of hospital stay, complication rate, level of intra-operative blood loss, 
complications, and conversion rates were comparable or superior to conventional laparoscopic or open 
technologies (Section 6.4.1). 
In conclusion, the contributions of the Hugo™ RAS System to subject outcomes substantially outweigh 
the minimal reported risks and side effects associated with the use of this device. The overall residual 
risks associated with the Hugo™ RAS System have been determined to be acceptable. Therefore, these 
assessments present a favorable benefit/risk profile and justify the use of the product in humans and an 
evaluation of clinical data relevant to the proposed investigation. 
11.5 Risk Determination 
The Hugo™ RAS and instruments are considered significant risk. 
 
 
 

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12. Adverse Events and Device Deficiencies 
12.1 Adverse Events 
All Adverse Events (AEs) will be collected, starting from the time the informed consent form is signed 
through 30 days (+7) after the day of the procedure regardless of their severity or relationship to the 
Hugo™ RAS or study procedures. After 30 days, AEs will be assessed by the surgeon and those AEs 
deemed attributable to the underlying surgical indication, procedure or surgical device will be reported. 
All deaths will be collected via AE regardless of relatedness. Reporting of these events to Medtronic will 
occur on an AE Form, including event description, date of AE, treatment, resolution, assessment of both 
the seriousness of the AE and the relatedness to the system components. Each AE must be recorded on 
a separate AE eCRF. 
AE definitions used in this study are based on ISO 14155:2020 (Clinical Investigation of Medical Devices 
for Human Subjects -- Good Clinical Practice). Documented pre-existing conditions are not considered 
AEs unless the nature or severity of the condition has worsened. See Section 14.1 for details regarding 
AE analyses in each study analysis set. In addition, AEs impacting users or other persons (non-subject 
AEs) will be collected on a non-subject AE CRF. 
Any unresolved procedural or device-related events that are still ongoing past study exit will be 
monitored by the physician per their institutional standard-of-care. 
Unavoidable adverse events (UAE) (those that are inherent to the procedure and are expected to occur 
in all subjects for an expected duration) listed in Table 9 will not be captured or reported unless the 
adverse event worsens or persists outside the stated timeframe post procedure. Section 11.1 includes a 
list of several, but not an all-encompassing anticipated adverse events. 
All deaths, serious adverse events related to the Hugo™ RAS System and/or study procedures and 
Clavien-Dindo Grade III and IV complications will be adjudicated by an independent CEC. 
 
12.2 Device Deficiency 
The device deficiency (DD) definition is provided in Table 7. DD information will be collected throughout 
the study and reported to Medtronic on a DD eCRF. Note that DDs that result in an AE to the subject 
should be captured as an AE only. 
 
12.3 Processing Updates and Resolution 
For any changes in status of a previously reported adverse event or DD (i.e., change in actions taken, 
change in outcome, change in relatedness), information needs to be updated on, or added to the 
original AE or DD form. All AEs must be followed until the AE has been resolved, is unresolved with no 
further actions planned, the subject dies or exits the study, whichever occurs first. 
In the event that a subject is exited from the study prior to study completion, all efforts should be made 

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• 
the event involves a body-site or an organ not expected to 
be affected by the device or procedure; 
• 
the event can be attributed to another cause (e.g., an 
underlying or concurrent illness/ clinical condition, an effect 
of another device, drug, treatment or other risk factors); 
• 
the event does not depend on a false result given by the 
device used for diagnosis, when applicable; 
In order to establish the non-relatedness, not all the criteria 
listed above might be met at the same time, depending on the 
type of device/procedures and the event. 
Possible: The relationship is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g., an underlying 
or concurrent illness/ clinical condition or/and an effect of another 
device, drug, or treatment). Cases where relatedness cannot be 
assessed, or no information has been obtained should also be 
classified as possible. 
 
Probable: The relationship seems relevant and/or the event cannot 
reasonably be explained by another cause. 
 
Causal: The event is associated beyond reasonable doubt when: 
• 
the event is a known side effect of the product category the 
device belongs to or of similar devices and procedures; 
• 
the event has a temporal relationship with device 
use/application or procedures; 
• 
the event involves a body-site or organ that 
o the device or procedures are applied to; 
o the device or procedures have an effect on; 
 
• 
the event follows a known response pattern to the device (if 
the response pattern is previously known); 
 
• 
the discontinuation of device application (or reduction of the 
level of activation/exposure) and reintroduction of its use 
(or increase of the level of activation/exposure), impact on 
the event (when clinically feasible); 

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Serious Adverse Device 
Effect (SADE) 
(ISO 14155:2020, 3.44) 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Unanticipated Adverse 
Device Effect (UADE) 
(21 CFR 812.3(s) 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with a device, if that 
effect, problem, or death, was not previously identified in a nature, 
severity, or degree of incidence in the investigational plan or 
application (including a supplementary plan or application), or any 
other unanticipated serious problem associated with a device that 
relates to the rights, safety, or welfare of subjects. 
Complication 
Complications will be defined according to the Clavien-Dindo 
classification system.1 
Grade I: Any deviation from the normal postoperative course 
without the need for pharmacological treatment or surgical, 
endoscopic, and radiological interventions. Allowed therapeutic 
regimens are: drugs as antiemetics, antipyretics, analgetics, 
diuretics, electrolytes, and physiotherapy. This grade also includes 
wound infections opened at the bedside. 
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 (including CNS 
complications)* requiring IC/ICU management 
Grade IVa: Single organ dysfunction (including dialysis) 
Grade IVb: Multiorgan dysfunction 
Grade V: Death of a patient 
 
 

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• 
Death summary/hospital records (if available and allowed by state/local law) 
• 
Autopsy report (if available and allowed by state/local law) 
• 
Death certificate (if available and allowed by state/local law) 
12.6.1 
Death Classification and Reporting 
Sufficient information will be required in order to properly classify the subject’s death. The Investigator 
shall classify each subject death per the following definitions: 
• 
Cardiac Death: A death directly related to the electrical or mechanical dysfunction of the heart. 
o Sudden Cardiac Death: Natural death due to cardiac causes, indicated by abrupt loss of 
consciousness within one hour of the onset of acute symptoms; preexisting heart 
disease may have been known to be present, but the time and mode of death are 
unexpected. If time of onset cannot be determined, SCD will alternatively be defined as 
any unexpected cardiac death occurring out of the hospital or in the emergency room as 
dead on arrival. 
o Non-sudden Cardiac Death: All cardiac deaths that are not classified as sudden deaths, 
including all cardiac deaths of hospitalized subjects on inotropic support. 
• 
Non-cardiac Death: A death not classified as a cardiac death. 
• 
Unknown Cardiac Classification: Unknown death classification is intended for use only when 
there is insufficient or inadequate information to classify the death 
The CEC will review all deaths and provide a final adjudication of the relatedness of death. 
Regulatory reporting of Subject Deaths will be completed according to local regulatory requirements. 
 
12.7 Product Complaint Reporting 
Product complaint reporting and vigilance reporting are applicable, and AEs related to any market- 
released device during the study must be reported. The reporting of product complaints is not part of 
the study and should be done in addition to the AE reporting requirements. Refer to local regulations for 
reporting requirements. 
Product Complaint: Any written, electronic, or oral communication that alleges deficiencies related to 
the identity, quality, durability, reliability, safety, effectiveness, or performance of a medical device that 
has been placed on the market. 
Abuse: Abnormal use (definition acc. #4.1 of Meddev 2.12-1) 
Misuse: Use error (definition acc. #4.20 of Meddev 2.12-1). It is the responsibility of the Investigator to 
report all product complaint(s) associated with a medical device distributed by Medtronic, regardless of 
whether they are related to intended use, misuse, or abuse of the product. Reporting must be done 
immediately and via the regular channels for market-released products. The reporting of product     
 

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complaints by the clinical team must be done according to the local Standard Operating Procedures. 
Medtronic will notify the RAs (e.g., CA) as applicable for the following incidents immediately upon 
learning of them and is not limited to AEs and DDs only: 
Any malfunction or deterioration in the characteristics and/or performance of a device, as well as any 
inadequacy in the labeling or instructions for use which led or might have led to the death or serious 
deterioration in the state of health of a subject, user, or other person. 
Any technical or medical reason resulting in withdrawal of a device from the market by the 
manufacturer. 
Any serious deterioration in the state of health, including: 
Life-threatening illness or injury 
Permanent impairment of a body function or permanent damage to a body structure 
A condition necessitating medical or surgical intervention to prevent permanent impairment of a body 
function or permanent damage to a body structure. 
 
 
13. Data Review Committees 
13.1 Clinical Events Committee Review 
An external, independent CEC will be utilized to adjudicate AEs during the study. The CEC will consist of 
a minimum of three (3) non-Medtronic employed physicians that are not participating Investigators for 
the study, including a CEC chairperson. Medtronic personnel may attend a CEC meeting but will be 
non-voting members. 
 
The CEC will be external to Medtronic and independent of the study Investigators. The members will 
have specialties appropriate to the therapeutic areas and meet requirements established in the CEC 
Charter. The CEC Charter will define the CEC processes for member selection, meeting frequency, roles 
and responsibilities, procedures and record keeping. Prior to making a final adjudication decision, the 
CEC may request clarification and/or additional information from the Principal Investigator who 
reported the event. 
 
The site investigator may agree or disagree with the CEC’s adjudication, and the eCRF documenting the 
AE may be updated accordingly. Ultimately, the CEC’s adjudication will be captured in the eCRF used 
for data analysis. 
 
 
 
 
 

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Subject disposition will be illustrated in a CONSORT diagram. Subject visits will be tabulated and 
compliance to visit schedules and visit windows will be summarized. 
All statistical analyses will be performed using Statistical Analysis System (SAS) for Windows (version 9.4 
or higher, SAS Institute Inc. Cary, NC) or other widely accepted statistical or graphical software. 
All tests of treatment effects will be conducted at a two-sided alpha level of 0.05 unless otherwise 
stated. A P-value less than 0.05 is considered statistically significant. Confidence intervals will be 
presented at the 95% level unless otherwise stated. 
The study will be considered successful when the primary effectiveness and safety endpoints are met. 
 
14.2 Analysis Execution 
The study safety and performance analyses will occur after all subjects complete the 30-day follow-up. 
The analyses will include both primary and secondary 30-day objectives. A clinical study report will be 
prepared once all data collection has ended and all subjects have completed the 30-day follow-up or 
have been exited. Annual progress reports will be prepared for oncologic subjects through 5 years. A 
final report will be completed at the end of the 5-year follow-up that will include the 5-year secondary 
analyses. 
All available data will be included in the analysis. Sensitivity analysis may be performed for missing data 
to assess the robustness of study results as described in Section 14.11. 
14.3 Interim Analysis 
No interim analysis is planned for this study. Outcomes through 30 days for the first 15 roll-in cases will 
be summarized descriptively and provided to the FDA for initial review without statistical inferences. 
The roll-in subjects will be included in the final data analysis for the study. 
 
14.4 Primary Objectives 
A systematic literature search was conducted for Jan 1, 2018 – Jun 13, 2023 to identify published clinical 
data on the use of RAS devices in nephrectomy, prostatectomy, and cystectomy procedures. Literature 
data reporting on the study objectives were used to determine the appropriate sample sizes and 
performance goals for each endpoint and surgery cohort. The full bibliography of all 130 publications 
supporting the updated performance goals is included in Section 17.1. 
 
14.4.1 
Primary Objective #1 (Effectiveness) 
The primary effectiveness objective of this study is to confirm that the Medtronic Hugo™ RAS System is 
effective when used for urologic robotic assisted surgery. The primary effectiveness endpoint is the 
surgical success rate, as defined in Section 6.4.2. 

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14.4.2 
Primary Objective #2 (Safety) 
The primary safety objective of this study is to confirm that the Medtronic Hugo™ RAS System is safe 
when used for urologic robotic assisted surgery. The primary safety endpoint is the rate of subjects with 
major complications (meeting Grade III criteria or higher per the Clavien-Dindo Classification system) 
from the first incision through 30 days post-procedure. Further details can be found in Section 6.4.2. 
The primary safety hypothesis is to test the overall 30-day major complication rate (i.e., rate of subjects 
with one or more major complications) against a performance goal. Since the safety profiles or major 
complication rates are very different among the three surgeries, a separate performance goal is pre- 
specified for each of the three surgery types (as per FDA recommendation). The performance goals are 
determined based on published literature data. 
Let R be the 30-day major complication rate, and PG be performance goal for a specific surgery group. 
The statistical hypothesis is formulated as follows: 
H0: R ≥ PG vs. Ha: R < PG 
The hypothesis will be tested using the Clopper-Pearson exact method and the null hypothesis will be 
rejected if one-sided p-value is significant comparing to alpha determined after multiplicity adjustment 
as described in Section 14.12. 
 
 
Performance Goal Rationale and Sample Size 
The literature search was performed based on available literature for each of the three surgery types 
(nephrectomy, prostatectomy, cystectomy). Point estimates along with 95% and 99% predicted intervals 
were calculated to provide plausible range of potential effect sizes. Clinically meaningful margins and 
statistical precisions have been taken into account to determine the appropriate performance goals. In 
some situations, considerations were also given to align with the studies from comparable sample sizes. 
The calculation details and rationales are summarized in the following table. 
All sample size calculations are based on exact test. Presuming a one-sample proportion and one-sided 
test with the least alpha of 0.008 (0.025/3) when performing three hypothesis testing (nephrectomy, 
prostatectomy, and cystectomy, respectively) and adjusting for multiplicity in primary safety 
objectives, sample size justification and performance goals are described as below: 
 
 
 
 
 

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 
Complication rate: Overall rate of subjects with one or more major complications (Clavien-Dindo 
Grade I or higher), from the first incision through 30 days post-procedure 
 
Operative time 
 
Intraoperative estimated blood loss (mL) 
 
Transfusion rate 
 
Rate of device-related conversion 
 
Hospital length of stay 
 
Readmission rate (through 30 days) 
 
Reoperation rate (through 30 days) 
 
Mortality rate (through 30 days) 
 
Rate of device deficiencies 
 
The following long-term secondary endpoints will be assessed through 5 years in oncologic subjects: 
 
Overall survival 
 
Progression-free survival 
 
Disease-free survival 
 
Descriptive statistics will be used to summarize secondary endpoints. In addition, performance goals are pre-
specified based on meta-analysis of published study data as well as considerations of clinically meaningful margins 
and statistical confidences for most secondary endpoints (see details below; the full bibliography of 130 
publications supporting the updated performance goals is included in Section 17.1). 95% confidence intervals 
might be provided as appropriate. Statistical evaluations for secondary objectives with performances goals are not 
powered in this study. Additionally, the secondary endpoints are planned to be analyzed using descriptive 
statistics, which broadly negate the need for multiplicity adjustments. 
 
The role of the secondary endpoints is to explore additional effects and outcomes associated with either 
the procedure or the disease state. The pre-specified performance goals serve as benchmarks for 
interpretation rather than thresholds for statistical significance of clinical trial success in this study. 
 
 
Performance Goals for Secondary Endpoints 
Performance goals are specified for each of the secondary endpoints. The details are summarized in the 
following table. 

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14.6 Ancillary Objectives 
Descriptive analyses of other pre-specified outcome measures beyond the primary and secondary 
objectives will be exploratory in nature and are not intended as a focus of the study for the evaluation of 
the study device. 
The following data will be collected as applicable: 
• 
Rate of positive surgical margins 
• 
Lymph node yield 
• 
Warm ischemia time 
• 
Surgeon experience 
14.7 Sample Size Determination 
The sample size for the study was estimated based on the primary safety and effectiveness hypotheses. 
Power calculation was performed using statistical software NCSS PASS 2023. 
The effectiveness hypothesis is to test if the surgical success rate is above the performance goal. The 
surgical success rate is expected to be 90% or higher. A performance goal is set to be 85%. A sample size 
of 126 subjects will provide more than 80% power at one-sided alpha of 0.025 (with an expected rate of 
95.2% or higher in this study). 
Safety is also considered for sample size determination. The primary safety endpoint is the major 
complication rate. A statistical hypothesis with a performance goal is specified for each of the three 
surgery types. The performance goals are determined based on analyses of published literature by 
taking into account clinically meaningful margins and statistical precisions. Each individual hypothesis is 
adequately powered with at least 80% power at a one-sided alpha level of 0.008 with multiplicity 
adjustment taken into consideration. The sample sizes for the three surgery types are up to 55, up to 
55 and up to 31 for Nephrectomy, Prostatectomy and Cystectomy respectively, after taking 10% 
attrition into account (up to 141 subjects in total). 
With the consideration of both effectiveness and safety, a total of up to 141 subjects are planned to be 
treated in this study. Up to six study sites will be used. To keep enrollment balance, each study site will 
be allowed to enroll no more than 30% of the total population. 
 
14.8 Demographics and Baseline Characteristics 
The number of subjects screened, treated, discontinued during the study, as well as the reasons for 
discontinuations will be summarized for all centers combined and each center separately. Disposition 
and reason for study discontinuation will also be provided as a by-subject listing. All demographics and 
baseline characteristics will be summarized using descriptive statistics. 

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14.9 Analysis Populations 
The following populations will be considered for the analysis of data for this study: 
Full Analysis Set 
The full analysis set (FAS) is defined as all enrolled subjects in whom the Hugo™ RAS procedure is begun, 
defined as the first skin incision. This is also known as a modified intent-to-treat (mITT) population. In 
the event that a subject is consented, but the first incision does not occur (e.g., if the subject becomes 
ineligible during the timeframe between consent and the procedure day), that subject will not be 
considered part of the FAS. The FAS will be the primary analysis set for the evaluation of the primary and 
secondary endpoints. 
AEs will be collected from the time of consent. AEs occurring in subjects excluded from the FAS will be 
followed for 30 days post-consent through study exit and will be reported in a listing in the clinical study 
report. These AEs will not be included in the primary FAS analysis for either AE reporting or the analysis 
of the primary and secondary endpoints. The number and proportion of subjects experiencing each type 
of adverse event will be summarized by site and overall for the FAS. 
Per Protocol Analysis Set 
The per protocol analysis set (PPAS) is a subset of the FAS including only those subjects without any 
major protocol deviations. Prior to data analysis, a protocol deviation listing will be produced and sent 
to the clinical manager/team for review in order to verify which subjects will be excluded from the PPAS. 
Reasons for exclusion of subjects from PPAS will be documented and reported. 
All enrolled subjects will be included in a subject disposition table indicating reasons for exclusion from 
the FAS and PPAS analysis sets. 
14.10 
Data Poolability 
An assessment of data poolability of the sites will be performed using logistic regression for the primary 
effectiveness endpoint. A significance level of 0.15 will be considered (per FDA recommendation). Sites 
with fewer than five subjects will be combined into large sites to ensure statistical robustness. If the 
sites are found to be significantly heterogeneous with respect to the primary endpoint, additional 
analyses will be conducted to further assess variations across sites in baseline and procedural variables 
that might contribute to the variations. 
 
14.11 
Missing Data and Sensitivity Analysis 
The primary analysis will be based on the full analysis set with no imputation of missing data. Sensitivity 
analysis will be performed for both the primary effectiveness and safety endpoints using multiple 
imputations 
for 
missing 
data 
if 
the 
missing 
data 
percentage 
is 
greater 
than 
5% 
(https://pubmed.ncbi.nlm.nih.gov/29207961/), as well as tipping-point analysis for the primary 
effectiveness endpoint to fully understand the missing data impact on the study results. 

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14.12 
Multiplicity Adjustment 
For the primary effectiveness endpoint only one hypothesis will be tested at alpha of 0.025 one-sided. 
For the primary safety endpoint (major complication rate), the closed test procedure (Holm’s method) 
will be used to protect the overall study-wise error rate for surgery types (Nephrectomy, Prostatectomy 
and Cystectomy). 
 
14.13 
Minimization of Bias 
Selection of subjects, treatment of subjects, and evaluation of study data are potential sources of bias. 
Methods incorporated in the study design to minimize potential bias include (but are not limited to): 
 
Potential for bias during this clinical investigation has been minimized by a well-controlled 
design, expected conduct under the terms of an approved clinical investigational plan and 
prospectively defined methods of data collection and analysis. 
 
All subjects meeting the study criteria will have all available data relevant to the study objectives 
collected per the investigational plan. 
 
Any known or foreseeable factors that comprise the outcomes of the clinical investigation or 
interpretation of results have been accounted for by the design the clinical investigation. 
In summary, potential sources of bias that may be encountered in this study have been considered and 
minimized by careful study design. 
 
15. Ethics 
15.1 Statement(s) of Compliance 
This study will be conducted in compliance with international ethical and scientific quality 
standards, known as GCP. GCP includes review and approval by an independent IRB before initiating 
a study, continuing review of an ongoing study by an IRB, and obtaining and documenting the freely 
given informed consent of a subject before initiating the study. 
The Expand URO study was designed to reflect GCP principles. These include the protection of the rights, 
safety and well-being of human subjects, controls to ensure the scientific conduct and credibility of the 
clinical investigation and the definition of responsibilities of the sponsor and Investigators. All 
Investigators shall avoid improper influence on or inducement of the subject, sponsor, monitor, other 
Investigator(s), or other parties participating in or contributing to the clinical investigation. 
The principles of the DoH have been implemented through the IC process, IRB approval, study training, 
clinical trial registration, pre-clinical testing, risk-benefit assessment, and publication policy. 
Ultimately, all study sites in all geographies will follow and comply with: 
• 
Principles of DoH 

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• 
21 CFR Part 11 (Electronic Records, Electronic Signatures) 
• 
21 CFR Part 54 (Financial Disclosure by Clinical Investigators) 
• 
The CTA 
• 
The procedures described within this CIP 
• 
Local IRB Requirements 
In addition to the regulatory requirements outlined above, the study will be conducted according to 
federal, national, and local laws, regulations, standards, and requirements of the 
countries/geographies where the study is being conducted. These include but are not limited to: 
• 
In the United States, the study will be conducted under an FDA IDE in compliance with 
21 CFR Parts: 
 
50: Protection of Human Subjects 
 
54: Financial Disclosure by Clinical Investigators 
 
56: IRBs 
 
812: IDEs 
 
The study will be publicly registered in accordance with the 2007 FDAAA and DoH on 
http://clinicaltrials.gov (PL 110-85, section 810(a)). In addition, the study may be registered in local 
regulatory databases where required by local law. 
Approval of the CIP and CIP amendments is required from the following groups prior to any study 
procedures at a study site: 
• 
Medtronic 
• 
Principal Investigators (where required by local law/regulations) 
• 
Geography-specific regulatory authorities (if regulatory approval is required) 
• 
An independent IRB. 
 
Similarly, approval of subsequent revisions to the CIP is required at each study site from the above-
mentioned groups prior to implementation of the revised CIP at the study site. Should an IRB or 
Regulatory Authority impose any additional requirements, they will be followed. If any action is taken by 
the IRB with respect to the investigation, that information is to be forwarded to Medtronic. 
Pediatric, legally incompetent, or other vulnerable subjects are not eligible for the study. No insurance 
or compensation will be provided to study subjects. 

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with recommendations for preventative/corrective actions to study site personnel. Monitors may work 
with study personnel to determine appropriate corrective action recommendations and to identify 
trends within the study or at a particular study site. 
 
16.2 Data Management 
Data will be collected using an electronic data management system for the study. eCRF data will be 
stored in a secure, password-protected database which will be backed up nightly. Data will be reviewed 
using programmed and manual data checks. Data queries will be made available to study sites for 
resolution. Study management reports may be generated to monitor data quality and study progress. At 
the end of the study, the data will be frozen and will be retained indefinitely by Medtronic. 
 
All records and other information about subjects participating in this study will be treated as 
confidential. Data will be transferred and processed by Medtronic, or a third party designated by 
Medtronic in a key coded form. 
 
Procedures in the CIP require source documentation. Source documentation will be maintained at the 
study site. Source documents, which may include worksheets, subject medical records, programmer 
printouts, and interrogation files, must be created and maintained by the investigational study site 
team. 
 
The Principal Investigator must ensure the accuracy, completeness, and timeliness of the recorded data 
and then provide his/her electronic signature on the appropriate eCRFs. 
 
The Investigator’s signature for specific eCRFs will be documented in compliance with local regulations. 
Changes to data previously submitted to the sponsor will require a new electronic signature by the 
Investigator to acknowledge/approve the changes. 
 
16.3 Direct Access to Source Data/Documents 
The Investigator(s)/institution(s) will permit inspection and study-related monitoring, audits, IRB review, 
and regulatory inspection(s), including direct access to original source data/documents per applicable 
laws and regulations. 
 
16.4 Confidentiality 
All information and data sent to parties involved in study conduct concerning subjects or their 
participation in this study will be considered confidential. Study sites will assign a unique SID to each 
subject. Records of the subject/SID relationship will be maintained by the study site. The SID number is 
to be recorded on all study documents to link them to the subject’s medical records at the study site. 
Confidentiality of data will be observed by all parties involved at all times throughout the clinical 
investigation.  

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All data shall be secured against unauthorized access. The privacy of each subject and confidentiality of 
his/her information shall be preserved in reports and when publishing any data. In the US, “Protected 
Health Information” (PHI) will be maintained in compliance with the HIPAA of 1996. To maintain 
confidentiality, the subject’s name or any other PHI should not be recorded on any study document 
other than the IC. This scenario will be covered in the IC. In the event a subject’s name/PHI is included 
for any reason, it will be blinded as applicable. In the event of inability to blind the identification (e.g., 
digital media), it will be handled in a confidential manner by the authorized personnel. Data relating to 
the study might be made available to third parties (for example in case of an audit performed by RA), 
provided the data are treated as confidential and that the subject’s privacy is guaranteed. No 
identifiable subject information will be published. 
16.5 Liability/Warranty/Insurance Information 
Medtronic maintains appropriate clinical study liability insurance coverage as required under applicable       
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage.  If required, a clinical study insurance statement/certificate will be provided to the IRB. 
 
16.6 CIP Amendments 
Any revisions or amendments to the CIP or IC document, will be submitted to the FDA according to 
applicable regulations. Approval by the FDA and the site’s IRB must be obtained prior to implementing a 
CIP revision at the study site. 
 
16.7 Record Retention 
The Principal Investigator will maintain the records of the study including all pertinent correspondence, 
the CIP with any/all amendments, all correspondence with and approval from the IRB, the clinical 
investigation agreement, the Investigator Agreement, individual subject records, and signed informed 
consent forms (ICFs). 
 
The Principal Investigator is responsible for ensuring that all essential study documentation is retained 
and accessible for a minimum period of two years after the date the investigation is completed or 
terminated, or the records are no longer required to support a marketing application (or longer in 
compliance to local requirements). The retention period may be longer if required by Medtronic or local 
or global regulatory requirements. Medtronic will not store any personal data longer than necessary and 
always in line with the required storage periods defined by the applicable laws. Medtronic will delete or 
make any personal data anonymous after the applicable storage period has expired. The Principal 
Investigator will ensure that essential study documents are not destroyed until written permission has 
been obtained from Medtronic. Medtronic will be notified in writing prior to the transfer of study 
documentation. 

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− Medtronic prohibits compensation for publication writing or editing activities to consultant 
health care providers (HCPs) (or to healthcare organizations) who serve as authors. Medtronic 
involvement in a publication (e.g., funding of the study; sponsor of the study; collection, analysis, 
and interpretation of data; professional writing assistance) must be disclosed according to 
journal-specific policies, submission requirements, and prevailing editorial standards, in addition 
to those specified by the ICMJE. Authors must ensure that an acknowledgement/disclosure 
statement is included in the body of the manuscript for Medtronic to review for accuracy. All 
authors must also disclose financial or personal affiliations that could be considered conflicts of 
interest as per journal/conference requirements. 
 
− In compliance with independent ethical codes across the industry, Medtronic does not reimburse 
Investigators or healthcare providers for travel or registration to present Medtronic-sponsored 
clinical study data at third party scientific conferences. 
 
16.9.1 
Publication Committee 
The study Steering Committee (Section 6.5) will also serve as the Publication Committee, in addition 
to appropriate members of the Medtronic medical and clinical departments (excluding marketing 
and sales). This committee will manage study publications with the goal of publishing findings from 
the data. The Publication Committee will develop the Publication Plan as a separate document. 
 
The Publication Committee’s role is to: (1) develop the Publication Plan under separate cover; (2) 
execute the Publication Plan; (3) oversee the publication of primary, secondary, and exploratory 
study results; (4) review and prioritize publication proposals; (5) provide input on publication 
content; and (6) apply and reinforce the authorship guidelines set forth in the Publication Plan. The 
committee will meet at regular intervals as needed. 
 
The Publication Committee may use professional medical writers to assist in writing publications 
and/or presentations; however, all medical writing support must be appropriately disclosed 
according to the Medtronic Publication and Authorship Policy and journal/conference policies. 
 
16.9.2 
Criteria for Determining Authorship 
− Publications will adhere to authorship criteria defined by the ICMJE. Individual authorship criteria 
defined by the target journal or conference will be followed when it differs from ICMJE criteria. 
 
− All authors, including Medtronic personnel, must meet all four of the conditions below: 
1. Substantial contributions to conception and design of the work, or the acquisition, analysis, or 
interpretation of data for the work; AND 
2. Drafting the work or revising it critically for important intellectual content; AND 
 
 

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3. Final approval of the version to be published; AND 
4. Agreement to be accountable for all aspects of the work in ensuring that questions related to 
the accuracy or integrity of any part of the work are appropriately investigated and resolved. 
− Study enrollment alone and membership in the Publication Committee do not guarantee 
authorship. Authorship on one publication does not guarantee authorship on any subsequent 
study publications. 
 
− Author selection strategy (based on ICMJE criteria) and potential authors will be discussed by the 
Publication Committee and included in the Publication Plan. Authorship will be evaluated on a 
continuous basis as writing and review progresses. Final authorship will be determined based on 
ICMJE contributions and must be reviewed by the Steering Committee prior to submission. 
 
16.9.3 
Transparency 
Transparency of clinical study results will be maintained by the following means: 
• 
A final report, describing the results of all objectives and analysis, will be distributed to all 
Investigators, IRBs, and RAs when required by local law 
• 
Registering and posting the study results on clinicaltrials.gov based on the posting rules 
stipulated 
• 
Submitting for publication the primary study results after the study ends 
• 
Disclosing conflicts of interest (e.g., financial) of the coauthors of publications according to the 
policies set forth by the corresponding journals and conferences 
• 
Making an individual study sites study data accessible to the corresponding Investigator after 
the completion of the study, if requested 
 
16.10 
Suspension or Early Termination 
16.10.1 
Planned Study Closure 
− Study Closure is a process initiated by distribution of a study closure letter. Study closure is 
defined as closure of a study that occurs when Medtronic and/or regulatory requirements have 
been satisfied per the CIP and/or by a decision by Medtronic or RA, whichever occurs first. The 
study closure process is complete upon distribution of the Final Report or after final payments, 
whichever occurs last. Ongoing IRB oversight is required until the overall study closure process is 
complete. Refer to Section 10.9 for additional information regarding study exit procedures. 
 
 

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16.10.2 
Early Termination or Suspension 
− Early Termination is the closure of a study that occurs prior to meeting defined endpoints. This is 
possible for the whole study or a single study site. 
 
− Suspension is a temporary postponement of study activities related to enrollment and 
distribution of the product. This is possible for the whole study or a single study site. 
 
16.10.2.1 
Study-wide Termination or Suspension 
Possible reasons for considering study-wide suspension or termination of the study include but 
are not limited to: 
• 
AEs associated with the system or product under investigation which might endanger 
the safety or welfare of the subject 
• 
Observed/suspected performance different from the product’s design intent 
• 
Decision by Medtronic or RA (where the study is operating under RA) 
• 
Technical issues during the manufacturing process 
Clavien-Dindo Grade IV complications will be continuously monitored by the sponsor for the 
safety and well-being of the subjects. Events reported as Clavien-Dindo Grade IV will be 
assessed by the Investigator and the sponsor as well as sent for adjudication by the 
independent CEC upon the sponsor’s awareness date for the reported event. 
 
Safety thresholds for Grade IV complication rates for the three study procedures are noted below: 
• 
Cystectomy: 10% 
• 
Nephrectomy: 8% 
• 
Prostatectomy: 5% 
• 
The above safety thresholds will be used by the sponsor to modify or stop the trial. The 
sponsor will review the Clavien-Dindo Grade IV complications for the first 30 subjects 
with 30-day data. A second review will be conducted for the second 30 subjects with 30- 
day data to ensure ongoing monitoring of subject safety. 
 
 
16.10.2.2 
Investigator/Study Site Termination or Suspension 
Possible reasons for an Investigator or study site termination or suspension include but are not 
limited to: 
 
• 
Failure to obtain initial IRB approval or annual renewal of the study 

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• 
Persistent non-compliance to the clinical investigation (e.g. failure to adhere to 
inclusion/exclusion criteria, failure to follow subjects per scheduled follow-ups) 
• 
Lack of enrollment 
• 
Noncompliance to regulations and the terms of the CTA (e.g. failure to submit data in a timely 
manner, failure to follow-up on data queries and monitoring observations in a timely manner, 
etc.) 
• 
IRB suspension of the study site 
• 
Fraud or fraudulent misconduct is discovered (as defined by local law and regulations) 
• 
Investigator request (e.g., no longer able to support the study) 
 
16.10.3 
Procedures for Termination or Suspension 
16.10.3.1 
Medtronic-initiated and Regulatory Authority-initiated 
• 
Medtronic will promptly inform the clinical Investigators of the termination or suspension and 
the reasons and inform the RAs where required 
• 
In the case of study termination or suspension for reasons other than a temporary IRB approval 
lapse, the Investigator will promptly inform the IRB 
• 
In the case of study termination, the Investigator must inform the subjects and may inform the 
personal physician of the subjects to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subject enrollment must stop until the suspension is lifted by 
Medtronic 
• 
In the case of a study suspension, enrolled subjects should continue to be followed out of 
consideration of their safety, rights and welfare 
 
16.10.4 
Procedures for Termination or Suspension 
 
16.10.4.1    Investigator-initiated 
• 
The Investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension 
• 
The Investigator will promptly inform the institution (where required per regulatory 
requirements) 

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• 
The Investigator will promptly inform the IRB 
• 
The Investigator will promptly inform the subjects and/or the personal physician of the subjects 
to ensure appropriate care and follow-up is provided 
• 
In the case of a study suspension, subjects enrolled should continue to be followed out of 
consideration of their safety, rights and welfare 
 
16.10.4.2    Ethics Committee-initiated 
• 
The Investigator will inform Medtronic and provide a detailed written explanation of the 
termination or suspension within 5 business days 
• 
Subject enrollment must stop until the suspension is lifted 
• 
Subjects already enrolled should continue to be followed in accordance with IRB policy or its 
determination that an overriding safety concern or ethical issue is involved 
• 
The Investigator will inform his/her institution (where required per local requirements) 
• 
The Investigator will promptly inform the subjects, or legally-authorized designees or guardians          
and/or the personal physician of the subjects, with the rationale for the study termination or       
suspension 
 
17. References 
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Veccia A, Antonelli A, Grob BM, et al. Impact of Robotic Surgery on Sick Leave and Return to 
Work in Patients Undergoing Radical Prostatectomy: An Evidence-Based Analysis. Urology 

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Practice. 2020;7(1):47-52. 
10. 
Wang L, Wang B, Ai Q, et al. Long-term cancer control outcomes of robot-assisted radical 
prostatectomy for prostate cancer treatment: a meta-analysis. International urology and 
nephrology. 2017;49(6):995-1005. 
11. 
Alder R, Zetner D, Rosenberg J. Incidence of Inguinal Hernia after Radical Prostatectomy: A 
Systematic Review and Meta-Analysis. J Urol. 2020;203(2):265-274. 
12. 
Clement KD, Pearce E, Gabr AH, Rai BP, Al-Ansari A, Aboumarzouk OM. Perioperative outcomes 
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cases. World J Urol. 2020. 
13. 
Feng D, Li A, Hu X, Lin T, Tang Y, Han P. Comparative effectiveness of open, laparoscopic and 
robot-assisted radical cystectomy for bladder cancer: a systematic review and network meta- 
analysis. Minerva Urol Nefrol. 2020;72(3):251-264. 
14. 
Feng D, Liu S, Tang Y, Yang Y, Wei W, Han P. Comparison of perioperative and oncologic 
outcomes between robot-assisted and laparoscopic radical cystectomy for bladder cancer: a 
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2020;52(7):1243-1254. 
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Tang JQ, Zhao Z, Liang Y, Liao G. Robotic-assisted versus open radical cystectomy in bladder 
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Tan WS, Khetrapal P, Tan WP, Rodney S, Chau M, Kelly JD. Robotic Assisted Radical 
Cystectomy with Extracorporeal Urinary Diversion Does Not Show a Benefit over Open 
Radical Cystectomy: A Systematic Review and Meta-Analysis of Randomised Controlled 
Trials. PLoS One. 2016;11(11):e0166221. 
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Shen Z, Sun Z. Systematic review and meta-analysis of randomised trials of perioperative 
outcomes comparing robot-assisted versus open radical cystectomy. BMC Urol. 2016;16(1):59. 
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Satkunasivam R, Tallman CT, Taylor JM, Miles BJ, Klaassen Z, Wallis CJD. Robot-assisted Radical 
Cystectomy Versus Open Radical Cystectomy: A Meta-analysis of Oncologic, Perioperative, and 
Complication-related outcomes. Eur Urol Oncol. 2019;2(4):443-447. 
19. 
Tzelves L, Skolarikos A, Mourmouris P, et al. Does the Use of a Robot Decrease the Complication 
Rate Adherent to Radical Cystectomy? A Systematic Review and Meta-Analysis of Studies 
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adults. Cochrane Database Syst Rev. 2019;4:CD011903. 
21. 
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related quality of life after robot-assisted versus open radical cystectomy: a systematic review 
and meta-analysis of four RCTs. Syst Rev. 2017;6(1):150. 
22. 
Kimura S, Iwata T, Foerster B, et al. Comparison of perioperative complications and health- 
related quality of life between robot-assisted and open radical cystectomy: A systematic review 
and meta-analysis. Int J Urol. 2019;26(8):760-774. 
23. 
Peng L, Li J, Cao D, et al. Can robotic-assisted radical cystectomy provide patients with a smaller 
trauma and faster recovery period? A systematic review and meta-analysis of comparative trials. 
J Cancer Res Clin Oncol. 2020;146(6):1591-1601. 
24. 
Albisinni S, Veccia A, Aoun F, et al. A systematic review and meta-analysis comparing the 
outcomes of open and robotic assisted radical cystectomy. Minerva Urol Nefrol. 2019;71(6):553- 
568. 
25. 
Cacciamani GE, Medina LG, Gill T, et al. Impact of Surgical Factors on Robotic Partial 
Nephrectomy Outcomes: Comprehensive Systematic Review and Meta-Analysis. J Urol. 

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2018;200(2):258-274. 
26. 
Wu Z, Li M, Liu B, et al. Robotic versus open partial nephrectomy: a systematic review and meta- 
analysis. PLoS One. 2014;9(4):e94878. 
27. 
Xia L, Wang X, Xu T, Guzzo TJ. Systematic Review and Meta-Analysis of Comparative Studies 
Reporting Perioperative Outcomes of Robot-Assisted Partial Nephrectomy Versus Open Partial 
Nephrectomy. J Endourol. 2017;31(9):893-909. 
28. 
Rai BP, Jones P, Tait C, et al. Is Cryotherapy a Genuine Rival to Robotic-assisted Partial 
Nephrectomy in the Management of Suspected Renal Malignancy? A Systematic Review and 
Meta-analysis. Urology. 2018;118:6-11. 
29. 
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2015;67(5):891-901. 
30. 
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Nephrectomy: an Updated Meta-Analysis of 4,919 Patients. J Urol. 2016;196(5):1371-1377. 
31. 
Tsai SH, Tseng PT, Sherer BA, et al. Open versus robotic partial nephrectomy: Systematic review 
and meta-analysis of contemporary studies. Int J Med Robot. 2019;15(1):e1963. 
32. 
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nephrectomy for localized renal tumors: a meta-analysis. Int J Clin Exp Med. 2014;7(12):4770- 
4779. 
33. 
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34. 
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With a New Robotic Surgical System for Cholecystectomy. Surgical Innovation. 2019;27(2):136- 
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Senhance robotic system. J Robot Surg. 2019;13(3):495-500. 
37. 
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platform with haptic feedback. Colorectal Dis. 2017;20. 
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surgery: single-center experience. Surg Endosc. 2016;30(1):215-221. 
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open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 
study. Lancet. 2016;388(10049):1057-1066. 
 
17.1 Bibliography of Publications Supporting Updated 
Statistical Design 
1. 
Agarwal VV, Thyavihally BY, Waigankar SS, et al. Perioperative, oncological, and survival 
outcomes of robotic radical cystectomy with urinary diversion in females: A single-center 
retrospective observational study. Indian Journal of Urology. 2023;39(1):27-32. 
2. 
Arora A, Pugliesi F, Zugail AS, et al. Comparing perioperative complications between 
laparoscopic and robotic radical cystectomy for bladder cancer. Journal of Endourology. 

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2020;34(10):1033-1040. 
3. 
Jeglinschi S, Carlier M, Denimal L, et al. Intracorporeal urinary diversion during robot-assisted 
radical cystectomy using indocyanine green. The Canadian journal of urology. 
2020;27(5):10394-10401. 
4. 
Piazza P, Bravi CA, Puliatti S, et al. Assessing pentafecta achievement after robot-assisted 
radical cystectomy and its association with surgical experience: Results from a high-volume 
institution. Urologic oncology. 2022;40(6):272.e211-272.e220. 
5. 
Piazza P, Rosiello G, Chacon VT, et al. Robot-assisted Cystectomy with Intracorporeal Urinary 
Diversion After Pelvic Irradiation for Prostate Cancer: Technique and Results from a Single 
High-volume Center. European urology. 2021;80(4):489-496. 
6. 
Tyson MD, Mi L. Preliminary Surgical Outcomes After Single Incision Robotic Cystectomy (SIRC). 
Urology. 2023;171:127-132. 
7. 
Abdul-Muhsin HM, McAdams SB, Syal A, et al. Robot Assisted Renal Allograft Nephrectomy: 
Initial Case Series and Description of Technique. Urology. 2020;146:118-124. 
8. 
Audige V, Baghli A, Hubert J, Mazeaud C, Larre S, Branchu B. Clinical and oncological outcomes 
of open partial nephrectomy versus robot assisted partial nephrectomy over 15 years. Journal 
of Robotic Surgery. 2023;17(2):519-526. 
9. 
Boga MS, Sonmez MG, Karamik K, et al. Long-term outcomes of minimally invasive surgeries in 
partial nephrectomy. Robot or laparoscopy? International Journal of Clinical Practice. 
2021;75(2):e13757. 
10. 
Boga MS, Ates M. Retroperitoneal robot-assisted laparoscopic partial nephrectomy for 
posterior located renal tumours: Technique and early term outcomes. International Journal of 
Clinical Practice. 2021;75(2):e13851. 
11. 
Garden EB, Al-Alao O, Razdan S, Mullen GR, Florman S, Palese MA. Robotic Single-Port Donor 
Nephrectomy with the da Vinci SP R Surgical System. JSLS : Journal of the Society of 
Laparoendoscopic Surgeons. 2021;25(4). 
12. 
Harrison R, Ahmed M, Billah M, et al. Single-port versus multiport partial nephrectomy: a 
propensity-score-matched comparison of perioperative and short-term outcomes. Journal of 
Robotic Surgery. 2023;17(1):223-231. 
13. 
Razdan S, Okhawere KE, Ucpinar B, et al. The State of Robotic Partial Nephrectomy: Operative, 
Functional, and Oncological Outcomes From A Robust Multi-Institution Collaborative. Urology. 
2023;173:92-97. 
14. 
Spaggiari M, Garcia-Roca R, Tulla KA, et al. Robotic Assisted Living Donor Nephrectomies: A 
Safe Alternative to Laparoscopic Technique for Kidney Transplant Donation. Annals of Surgery. 
2022;275(3):591-595. 
15. 
Uemura T, Kato T, Nagahara A, et al. Therapeutic and clinical outcomes of robot-assisted 
partial nephrectomy versus cryoablation for T1 renal cell carcinoma. In Vivo. 2021;35(3):1573-

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1579. 
16. 
Aldousari S, Yaiesh S, Alkandari O, Hussein S. Pathological features of prostate cancer in men 
treated with robot-assisted radical prostatectomy in the Middle East. Journal of Robotic 
Surgery. 2021;15(1):125-133.  
17. 
Bahouth Z, Laniado M, Fowler R, Charlesworth PJS. Positive Surgical Margins Rate of Retzius-
Sparing Robot-Assisted Radical Prostatectomy in a Contemporary, Unselected Cohort. 
Journal of Urology. 2022;207(3):609-616. 
18. 
Benarroche D, Paladini A, Grobet-Jeandin E, et al. Robotic versus open simple prostatectomy 
for benign prostatic hyperplasia in large glands: single-centre study. World journal of 
urology. 2022;40(12):3001-3006. 
19. 
Dobbs RW, Halgrimson WR, Madueke I, Vigneswaran HT, Wilson JO, Crivellaro S. Single-port 
robot-assisted laparoscopic radical prostatectomy: initial experience and technique with the 
da Vinci R SP platform. BJU international. 2019;124(6):1022-1027. 
20. 
Gaboardi F, Pini G, Suardi N, Montorsi F, Passaretti G, Smelzo S. Robotic laparoendoscopic 
single-site radical prostatectomy (R-LESS-RP) with daVinci Single-Site platform. Concept and 
evolution of the technique following an IDEAL phase 1. Journal of Robotic Surgery. 
2019;13(2):215-226. 
21. 
Islamoglu E, Aktas Y, Ari O, et al. Robotic-assisted laparoscopic prostatectomy: Initial 
experience of 267 cases. Bulletin of Urooncology. 2019;18(1):14-17. 
22. 
Kulis T, Hudolin T, Penezic L, et al. Comparison of extraperitoneal laparoscopic and 
extraperitoneal Senhance radical prostatectomy. The international journal of medical 
robotics + computer assisted surgery : MRCAS. 2022;18(1):e2344. 
23. 
Lee Z, Lee M, Keehn AY, Asghar AM, Strauss DM, Eun DD. Intermediate-term Urinary 
Function and Complication Outcomes After Robot-Assisted Simple Prostatectomy. Urology. 
2020;141:89-94. 
24. 
Martinez PF, Romeo A, Tobia I, Isola M, Giudice CR, Villamil WA. Comparing open and 
robotic salvage radical prostatectomy after radiotherapy: predictors and outcomes. Prostate 
International. 2021;9(1):42-47. 
25. 
Moreno-Sierra J, Galante-Romo MI, Senovilla-Perez JL, et al. Oncologic outcomes in 408 
consecutive patient cohort treated with da Vinci robot-assisted radical prostatectomy. 
Resultados oncologicos de un programa de prostatectomia radical asistida por robot <> en 
una cohorte de 408 pacientes consecutivos. 2020;44(3):179-186. 
26. 
Siripalangkanont J, Panumatrassamee K. Comparison of Treatment Outcomes between 
Laparoscopic and Robot-Assisted Laparoscopic Radical Prostatectomy in Clinically Localized 
Prostate Cancer, A Single-Surgeon Experience. Journal of the Medical Association of 
Thailand. 2020;103(12):1300-1308. 
27. 
Tamhankar AS, Patil S, Singh S, et al. Selecting lymph node-positive patients for adjuvant 
therapy after radical prostatectomy and extended pelvic lymphadenectomy: An outcome 

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analysis of 100 node-positive patients managed without adjuvant therapy. Current Urology. 
2022;16(4):232-239. 
28. 
Wilson CA, Aminsharifi A, Sawczyn G, et al. Outpatient Extraperitoneal Single-Port Robotic 
Radical Prostatectomy. Urology. 2020;144:142-146. 
29. 
Buse S, Alexandrov A, Mazzone E, Mottrie A, Haferkamp A. Surgical benchmarks, mid-
term oncological outcomes, and impact of surgical team composition on simultaneous 
enbloc robot-assisted radical cystectomy and nephroureterectomy. BMC urology. 
2021;21(1):73. 
30. 
Jin HJ, Shim JS, Kwon TG, et al. Gender-related outcomes in robot-assisted radical 
cystectomy: A multi-institutional study. Investigative and Clinical Urology. 2022;63(1):53-
62. 
31. 
Maibom SL, Roder MA, Aasvang EK, et al. Open vs robot-assisted radical cystectomy 
(BORARC): a double-blinded, randomised feasibility study. BJU International. 
2022;130(1):102-113. 
32. 
Tamhankar AS, Ahluwalia P, Patil SR, Nambiath S, Gautam G. Implementation of ERAS 
protocol in robot-assisted radical cystectomy with intracorporeal ileal conduit urinary 
diversion: An outcome analysis beyond the learning curve. Indian journal of urology: IJU: 
journal of the Urological Society of India. 2020;36(1):37-43. 
33. 
Alimi Q, Peyronnet B, Sebe P, et al. Comparison of Short-Term Functional, Oncological, 
and Perioperative Outcomes between Laparoscopic and Robotic Partial Nephrectomy 
beyond the Learning Curve. Journal of Laparoendoscopic and Advanced Surgical 
Techniques. 2018;28(9):1047-1052. 
34. 
Brunotte M, Rademacher S, Weber J, et al. Robotic assisted nephrectomy for living kidney 
donation (RANLD) with use of multiple locking clips or ligatures for renal vascular closure. 
Annals of translational medicine. 2020;8(6):305. 
35. 
Buffi NM, Saita A, Lughezzani G, et al. Robot-assisted Partial Nephrectomy for Complex 
(PADUA Score >=10) Tumors: Techniques and Results from a Multicenter Experience at 
Four High-volume Centers. European urology. 2020;77(1):95-100. 
36. 
Casale P, Lughezzani G, Buffi N, Larcher A, Porter J, Mottrie A. Evolution of Robot-assisted 
Partial Nephrectomy: Techniques and Outcomes from the Transatlantic Robotic Nephron-
sparing Surgery Study Group. European urology. 2019;76(2):222-227. 
37. 
El-Asmar JM, Sebaaly R, Mailhac A, et al. Use of Bariatric Ports in 4-Arm Robotic Partial 
Nephrectomy: A Comparative Study With the Standard 3-Arm Technique. Cureus. 
2021;13(7):e16461. 
38. 
Francavilla S, Abern MR, Dobbs RW, et al. Single-Port robot assisted partial nephrectomy: 
initial experience and technique with the da Vinci Single-Port platform (IDEAL Phase 1). 
Minerva urology and nephrology. 2022;74(2):216-224. 

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39. 
Furukawa J, Hinata N, Teisima J, et al. Robot-assisted partial nephrectomy with minimum 
follow-up of 5 years: A multi-center prospective study in Japan. Int J Urol. 
2022;29(9):1038-1045. 
40. 
Furukawa J, Kanayama H, Azuma H, et al. 'Trifecta' outcomes of robot-assisted partial 
nephrectomy: a large Japanese multicenter study. International Journal of Clinical 
Oncology. 2020;25(2):347-353. 
41. 
Gallo F, Sforza S, Luciani L, et al. Simultaneous robotic partial nephrectomy for bilateral renal 
masses. World journal of urology. 2022;40(4):1005-1010. 
42. 
Hussein AA, Mohsin R, Qureshi H, et al. Transition from da Vinci to Versius robotic surgical 
system: initial experience and outcomes of over 100 consecutive procedures. Journal of robotic 
surgery. 2023;17(2):419-426. 
43. 
Idu MM, Bemelman F, Nurmohamed A, van der Pant K. Robot-assisted donor nephrectomy: 
Initial results and comparison with the hand-assisted laparoscopic technique. A retrospective 
study. International Journal of Surgery Open. 2022;43:100481. 
44. 
Kim J, Na JC, Lee JS, Jang WS, Han WK. Clinical Implications for da Vinci SP Partial Nephrectomy 
in High-Complexity Tumors: Propensity Score-Matching Analysis. Journal of endourology. 
2022;36(10):1290-1295. 
45. 
Li X, Xu W, Fan S, et al. Robot-assisted Partial Nephrectomy with the Newly Developed KangDuo 
Surgical Robot Versus the da Vinci Si Surgical System: A Double-center Prospective Randomized 
Controlled Noninferiority Trial. European urology focus. 2023;9(1):133-140. 
46. 
Motoyama D, Aki R, Matsushita Y, et al. Early Single-Center Experience with Robotic Partial 
Nephrectomy Using the da Vinci Xi: Comparative Assessment with Conventional Open Partial 
Nephrectomy. Current Urology. 2019;13(1):13-18. 
47. 
Motoyama D, Ito T, Sugiyama T, Otsuka A, Miyake H. Comparison of perioperative outcomes 
among patients with exophytic, mesophytic, and endophytic renal tumors undergoing robot-
assisted partial nephrectomy. Int J Urol. 2022;29(9):1026-1030. 
48. 
Pellegrino AA, Chen G, Morgantini L, Calvo RS, Crivellaro S. Simplifying Retroperitoneal Robotic 
Single-port Surgery: Novel Supine Anterior Retroperitoneal Access. European Urology. 2023. 
49. 
Pradere B, Peyronnet B, Khene ZE, Mathieu R, Verhoest G, Bensalah K. Simplified robot-assisted 
partial nephrectomy: step-by-step technique and perioperative outcomes. Journal of Robotic 
Surgery. 2019;13(2):245-251. 
50. 
Seyam RM, Alalawi MM, Alkhudair WK, et al. Operative outcomes of robotic partial 
nephrectomy: A report of the first 101 cases from a single center in Saudi Arabia. Saudi Medical 
Journal. 2019;40(1):33-40. 
51. 
Shukla D, Small A, Mehrazin R, Palese M. Single-port robotic-assisted partial nephrectomy: 
initial clinical experience and lessons learned for successful outcomes. Journal of robotic 
surgery. 2021;15(2):293-298. 

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52. 
Takagi K, Kimenai HJAN, Terkivatan T, Tran KTC, Ijzermans JNM, Minnee RC. Learning curves of 
minimally invasive donor nephrectomy in a high-volume center: A cohort study of 1895 
consecutive living donors. International Journal of Surgery. 2021;86:7-12. 
53. 
Wang J, Fan S, Shen C, et al. Partial nephrectomy through retroperitoneal approach with a new 
surgical robot system, KD-SR-01. Int j med robot comput assist surg. 2022;18(2):e2352. 
54. 
Xu W, Dong J, Xie Y, et al. Robot-Assisted Partial Nephrectomy with a New Robotic Surgical 
System: Feasibility and Perioperative Outcomes. Journal of endourology. 2022;36(11):1436-
1443. 
55. 
Zhuang J, Yang X, Qian J, et al. Renal Functional and Perioperative Outcomes of 
Retroperitoneal Robot-Assisted Versus Laparoscopic Partial Nephrectomy with Segmental 
Renal Artery Clamping. Journal of Laparoendoscopic and Advanced Surgical Techniques. 
2022;32(5):545-549. 
56. 
Abou Zeinab M, Kaviani A, Ferguson EL, Beksac AT, Eltemamy M, Kaouk J. A Transition Toward 
a Faster Recovery in Single-Port Transvesical Simple Prostatectomy. Journal of Endourology. 
2022;36(8):1036-1042. 
57. 
Agarwal DK, Sharma V, Toussi A, et al. Initial Experience with da Vinci Single-port Robot-
assisted Radical Prostatectomies. European Urology. 2020;77(3):373-379. 
58. 
Alip S, Koukourikis P, Han WK, Rha KH, Na JC. Comparing Revo-i and da Vinci in Retzius-Sparing 
Robot-Assisted Radical Prostatectomy: A Preliminary Propensity Score Analysis of Outcomes. 
Journal of Endourology. 2022;36(1):104-110. 
59. 
Anakievski D, Marinov R, Gocheva I, Nikolov V, Abushev P. ROBOT-ASSISTED RADICAL 
PROSTATECTOMY WITH DA VINCI XI: OUR INITIAL EXPERIENCE. Journal of IMAB - Annual 
Proceeding (Scientific Papers). 2022;28(1):4310-4315. 
60. 
Balestrazzi E, Paciotti M, Piro A, et al. Comparative analysis of robot-assisted simple 
prostatectomy: the HUGO™ RAS system versus the DaVinci® Xi system. Prostate Cancer and 
Prostatic Diseases. 2023. 
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Bassett JC, Salibian S, Crivellaro S. Single-Port Retzius-Sparing Robot-Assisted Radical 
Prostatectomy: Feasibility and Early Outcomes. Journal of endourology. 2022;36(5):620-625. 
62. 
Cardi A, Palleschi G, Patruno G, et al. Robot-assisted simple prostatectomy for treatment of 
large prostatic adenomas: surgical technique and outcomes from a high-volume robotic centre. 
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63. 
Chang Y, Xu W, Lu X, et al. Robotic Perineal Radical Prostatectomy: Initial Experience with the 
da Vinci Si Robotic System. Urologia internationalis. 2020;104(9-10):710-715. 
64. 
Deng W, Chen R, Zhu K, et al. Functional Preservation and Oncologic Control following Robot-
Assisted versus Laparoscopic Radical Prostatectomy for Intermediate- and High-Risk Localized 
Prostate Cancer: A Propensity Score Matched Analysis. Journal of Oncology.  

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65. 
Fan S, Hao H, Chen S, et al. Robot-Assisted Laparoscopic Radical Prostatectomy Using the 
KangDuo Surgical Robot System vs the da Vinci Si Robotic System. Journal of endourology. 
2023;37(5):568-574. 
66. 
Fan S, Zhang Z, Wang J, et al. Robot-Assisted Radical Prostatectomy Using the KangDuo 
Surgical Robot-01 System: A Prospective, Single-Center, Single-Arm Clinical Study. Journal 
of Urology. 2022;208(1):119-127. 
67. 
Francavilla S, Veccia A, Dobbs RW, et al. Radical prostatectomy technique in the robotic 
evolution: from da Vinci standard to single port-a single surgeon pathway. Journal of 
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68. 
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Abou Zeinab M, Beksac AT, Corse T, et al. The Multi-Institutional Experience in Single-Port 
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Abou Zeinab M, Beksac AT, Ferguson E, et al. Single-port Extraperitoneal and Transperitoneal 
Radical Prostatectomy: A Multi-Institutional Propensity-Score Matched Study. Urology. 
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Carbonara U, Minafra P, Papapicco G, et al. Xi Nerve-sparing Robotic Radical Perineal 
Prostatectomy: European Single-center Technique and Outcomes. European Urology Open 
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91. 
Chen SH, Wu CH, Wu R, et al. Surgical and functional outcomes of robotic-assisted radical 
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92. 
Covas Moschovas M, Bhat S, Onol F, Rogers T, Patel V. Early outcomes of single-port robot-
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93. 
Covas Moschovas M, Kind S, Bhat S, et al. Implementing the da Vinci SP Without Increasing 
Positive Surgical Margins: Experience and Pathologic Outcomes of a Prostate Cancer Referral 
Center. Journal of endourology. 2022;36(4):493-498. 
94. 
Khalil MI, Chase A, Joseph JV, Ghazi A. Standard Multiport vs Single-Port Robot-Assisted 
Simple Prostatectomy: A Single-Center Initial Experience. Journal of endourology. 
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95. 
Levy A, Wilder S, Butaney M, et al. Solving clinical challenges in prostate cancer using the 
single-port robot system. Urology Video Journal. 2023;18:100222. 
96. 
Moschovas MC, Bhat S, Sandri M, et al. Comparing the Approach to Radical Prostatectomy 
Using the Multiport da Vinci Xi and da Vinci SP Robots: A Propensity Score Analysis of 
Perioperative Outcomes. European urology. 2021;79(3):393-404. 
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Ni K, Xue D, Li G. Transperineal single-port robot-assisted radical prostatectomy with Si da 
Vinci surgical system: Initial experience and description of technique. Translational Cancer 
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98. 
Noh TI, Tae JH, Shim JS, et al. Initial experience of single-port robot-assisted radical 
prostatectomy: A single surgeon's experience with technique description. Prostate 
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99. 
Noh TI, Kang YJ, Shim JS, et al. Single-Port vs Multiport Robot-Assisted Radical Prostatectomy: 
A Propensity Score Matching Comparative Study. Journal of endourology. 2022;36(5):661-
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Gross JT, Vetter JM, Sands KG, et al. Initial Experience with Single-Port Robot-Assisted Radical 
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103. 
Bang S, Shin D, Moon HW, et al. Comparison of Transperitoneal and Retroperitoneal Partial 
Nephrectomy with Single-Port Robot. Journal of endourology. 2023;37(5):551-556. 
104. 
Glaser ZA, Burns ZR, Fang AM, et al. Single- versus multi-port robotic partial nephrectomy: a 
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105. 
Kishore TA, Pathrose G, Raveendran V, et al. Robot-assisted laparoscopic radical 
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107. 
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108. 
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127. Venckus R, Jasenas M, Telksnys T, et al. Robotic-assisted radical prostatectomy with the 
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18. Appendices 
18.1 RAS URO Clavien-Dindo Grades and Examples 
Reference: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal 
with evaluation in a cohort of 6336 subjects and results of a survey. Ann Surg. 2004;240(2):205-213. 
https://www.ncbi.nlm.nih.gov/pubmed/15273542 
 
Grade 
Definition 
Grade I 
Any deviation from the normal postoperative course without the need for 
pharmacological treatment or surgical, endoscopic, and radiological interventions. 
Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, 
diuretics, electrolytes, and physiotherapy. This grade also includes wound infections 
opened at the bedside. 
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 (including CNS complications)* requiring IC/ICU 
management 

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Grade 
Definition 
Grade IVa 
Single organ dysfunction (including dialysis) 
Grade IVb 
Multiorgan dysfunction 
Grade V 
Death of a patient 
*Brain hemorrhage, ischemic stroke, subarrachnoidal bleeding, but excluding transient ischemic attacks. CNS, 
central nervous system; IC, intermediate care; ICU, intensive care unit. 
 
 
Grades 
Organ System 
Examples 
Grade I 
Cardiac 
Atrial fibrillation converting after correction of K+-level 
Respiratory 
Atelectasis requiring physiotherapy 
Neurological 
Transient confusion not requiring therapy 
Gastrointestinal 
Noninfectious diarrhea 
 
 
 
Grades 
Organ System 
Examples 
Renal 
Transient elevation of serum creatinine 
Other 
Wound infection treated by opening of the wound at the bedside 
Grade II 
Cardiac 
Tachyarrhythmia requiring 13-receptor antagonists for heart rate control 
Respiratory 
Pneumonia treated with antibiotics on the ward 
Neurological 
TIA requiring treatment with anticoagulants 
Gastrointestinal 
Infectious diarrhea requiring antibiotics 
Renal 
Urinary tract infection requiring antibiotics 
Other 
Same as for I but followed by treatment with antibiotics because of additional 
phlegmonous infection 
Grade IIIa 
Cardiac 
Bradyarrhythmia requiring pacemaker implantation in local anesthesia 

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Grades 
Organ System 
Examples 
Neurological 
See grade IV 
Gastrointestinal 
Biloma after liver resection requiring percutaneous drainage 
Renal 
Stenosis of the ureter after kidney transplantation treated by stenting 
Other 
Closure of dehiscent noninfected wound in the OR under local anesthesia 
Grade IIIb 
Cardiac 
Cardiac temponade after thoracic surgery requiring fenestration 
Respiratory 
Bronchopleural fistulas after thoracic surgery requiring surgical closure 
Neurological 
See grade IV 
Gastrointestinal 
Anastomotic leakage after descendorectostomy requiring relaparotomy 
Renal 
Stenosis of the ureter after kidney transplantation treated by surgery 
Other 
Wound infection leading to eventration of small bowel 
Grade IVa 
Cardiac 
Heart failure leading to low-output syndrome 
Respiratory 
Lung failure requiring intubation 
Neurological 
Ischemic stroke/brain hemorrhage 
Gastrointestinal 
Necrotizing pancreatitis 
Renal 
Renal insufficiency requiring dialysis 
Grade IVb 
Cardiac 
Same as for IVa but in combination with renal failure 
Respiratory 
Same as for IVa but in combination with renal failure 
Gastrointestinal 
Same as for IVa but in combination with hemodynamic instability 
Neurological 
Ischemic stroke/brain hemorrhage with respiratory failure 
Renal 
Same as for IVa but in combination with hemodynamic instability 
Suffix “d” 
Cardiac 
Cardiac insufficiency after myocardial infarction (IVa–d) 
Respiratory 
Dyspnea after pneumonectomy for severe bleeding after chest tube placement (IIIb– 
d) 

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Grades 
Organ System 
Examples 
 
Gastrointestinal 
Residual fecal incontinence after abscess following descendorectostomy with surgical 
evacuation. (IIIb–d) 
 
Neurological 
Stroke with sensorimotor hemisyndrome (IVa–d) 
Renal 
Residual renal insufficiency after sepsis with multiorgan dysfunction (IVb–d) 
Other 
Hoarseness after thyroid surgery (I–d) 
TIA, transient ischemic attack; OR, operating room. 
 
18.2 Report of Prior Investigations 
Provided under separate cover. 
 
18.3 Instructions for Use/Labeling 
Provided under separate cover. 
 
18.4 Sample Informed Consent Form 
Provided under separate cover. 
 
18.5 Training Plan 
Provided under separate cover. 
 
18.6 List of Monitors 
Provided under separate cover. 
 
18.7 List of Institutions 
Provided under separate cover.