HYROS (HYbrid RObotic Surgery in Urology)
Phase: NA
Conditions: Nephrectomy
Sponsor: Rob Surgical Systems S.L.

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CONFIDENTIAL 
Printed copies are uncontrolled unless otherwise identified 
Title:  Clinical Investigation Plan. HYROS (HYbrid RObotic Surgery in urology) 
Standards and applying chapters: According to IF-PR01-022 Bitrack_Applicable Regulation and IF-
PR01-023_A8 Bitrack Aplicable standards 
Protocol Nr: PL-PR01-027 
Revision Nr: A2 
Date of issue: 04-OCT-2022 
Project Code: PR01 
Author: AKRN Scientific Consulting 

 
 
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CONTACT INFORMATION 
SPONSOR AND LEGAL MANUFACTURER 
Rob Surgical Systems, S.L. 
Autovia de Castelldefels C-31 km 190.5, El Prat de Llobregat (Barcelona, Spain), 08820 
 
  
 
Central CRO:  
AKRN Scientific Consulting S.L. 
 
 
 
SITE PRINCIPAL INVESTIGATOR: 
Hospital Clinic de Barcelona 
 
 
 
 
 
 

 
 
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CLINICAL INVESTIGATION PLAN (CIP) SUMMARY 
Version Number 
2.0 
Date 
04-October-2022 
Sponsor 
Rob Surgical Systems, S.L. 
Autovia de Castelldefels C-31, km 190.5 
El Prat de Llobregat (Barcelona, Spain), 08820 
Clinical Investigation 
Identification 
HYROS 
Title 
HYbrid RObotic Surgery in urology 
Objectives 
The purpose of this early feasibility clinical investigation is to evaluate the safety 
and feasibility of the Bitrack System and its corresponding ESE and NESE 
instruments 
 in patients with the indication of a robot assisted 
laparoscopic radical/simple nephrectomy. 
 
 
Device Under 
Investigation 
Bitrack System along with its ESE/NESE instruments  
Number of Subjects 
Required for Clinical 
Investigation 
3 subjects shall be included in this early feasibility clinical investigation 
Planned Number of 
Sites 
1 investigational site located in Spain   
Clinical Investigation 
Design 
This is a single-center, early feasibility, and first in human (FIH) clinical 
investigation with a single arm, open label and non-randomized design 
Primary Endpoints 
The primary safety and performance endpoints of this early feasibility 
investigation are: 
1) Evaluation of the safety of the Bitrack System by measuring the occurrence 
of Procedure-Related Adverse Events (PRAEs) and Serious Adverse 
Events (SAEs) during the procedure and through the 30 days post-
procedure period of enrolled patients indicated for robot assisted 
laparoscopic radical/simple nephrectomy. 
2) Evaluation of the performance of the investigational devices by means of 
its ability to access and reach the target zone, perform all relevant surgical 
tasks and to be withdrawn efficiently without conversion to MIS or open 
surgery. The performance of the Bitrack System and the ESE/NESE 
instruments will be analyzed through the conversion rate to conventional 
laparoscopy/open surgery. 

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Secondary Endpoints 
The secondary endpoints planned for this clinical investigation are listed below: 

All AE(s) events during the procedure and through the 30 days post-
procedure will also be assessed, and therefore relationship with the
investigational device and/or procedure will be examined by the
principal investigator and reported to Rob Surgical.
o
Timeframe: Procedure, discharge, 14 days and 30 days follow-
up

Individual safety (i.e., absence of unwanted injure of any tissue) and
performance (VAS scale 0-10 following the subjective surgeon’s
opinion, being 0 a non-functional tool and 10 an instrument that works
exactly equivalent to the surgeon/s hands) for each instrument surgical
function.
o
Timeframe: Procedure

Blood Loss defined as estimated mL of blood loss, transfusion rates
and use of hemostasis agents.
o
Timeframe: Procedure

Operative Time Procedure measurement for the different tasks.
o
Timeframe: Procedure

To evaluate post-operative pain in patients through the Cumulative
Analgesic Consumption Score (CACS) during the first week (7days)
post-procedure.
o
Timeframe: Discharge

To assess the duration of subject’s hospitalization as the Length of
Stay (LoS) in hospital calculated from day of admission to day of
discharge.
o
Timeframe: Discharge

Patient pain assessment via VAS. Patient interview questions.
o
Timeframe: Discharge, 14- and 30-days post-procedure

Post-procedure complication rates, including the measurement of the
comprehensive complication index (CCI) on a scale from 0 (no
complications) to 100 (death), and the Clavien-Dindo classification,
which consists of 7 grades (I, II, IIIa, IIIb, Iva, Ivb and V), the first one
indicating any deviation from the normal postoperative course, the
highest-grade indicating death.
o
Timeframe: Discharge,14 and 30 days follow-up
Subject Follow-up 
Subjects will have a 14-days in clinic visit and a 30-days post-procedure remote 
clinical follow-up visit 
Inclusion Criteria 
1.
Adult subjects between 18 and 90 years old

 
 
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2. Subjects must provide written informed consent prior to any clinical 
investigation related procedure 
3. Subjects who have been scheduled for a laparoscopic radical/simple 
nephrectomy surgery  
4. Ability and willingness to comply with all study requirements to be 
evaluated for each study visit 
Exclusion Criteria 
1. Pregnant or breastfeeding women at the time of the surgery 
2. Inability to adhere to study-related procedures 
3. Subject has known allergy to some of the device components (i.e., 
stainless steel, etc.) 
4. Subjects who participate in another trial which may affect the outcome 
data on this study or the ability to complete the follow up requirements 
5. Subjects not suitable to undergo MIS/MIRS, according to medical 
criteria 
6. Subjects with life expectancy inferior to 3 months 
7. Subjects with a BMI ≥ 40. 
8. Subjects with severe cardiopulmonary or coronary artery disease, 
bleeding disorders or that have been submitted to multiple prior 
operations. 
9. Subjects with abuses of active substances or with uncontrolled 
psychiatric disorders. 
10. Subjects scheduled for surgeries intended to be in direct contact with 
the heart, the central circulatory system or the central nervous system 
11. Subjects with any contraindication for the use of the Bitrack System 
and the ESE/NESE instruments, as specified in the Instructions For 
Use 
Electronic Data Capture 
  
Expected Duration of 
the Study 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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COMPLIANCE STATEMENT:  
This clinical investigation will be conducted in accordance with this Clinical Investigation Plan, the Declaration 
of Helsinki, ISO 14155:2020 standards, EU Regulation 2017/745 (MDR) and the appropriate local legislation(s). 
The most stringent requirements, guidelines or regulations must always be followed. The conduct of the clinical 
investigation will be approved by the appropriate Ethics Committee (EC) of the respective clinical site and as 
specified by local regulations. Any additional requirement imposed by the EC will be followed.  
 
CONFIDENTIALITY STATEMENT 
This document is confidential and is to be distributed for review only to investigators, potential investigators, 
consultants, study staff, and applicable independent Ethics Committees or Competent Authorities. The contents 
of this document shall not be disclosed to others without written authorization from the Sponsor unless it is 
necessary to obtain informed consent from potential study participants. 
 
 

 
 
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TABLE OF CONTENTS 
SUMMARY OF CHANGES ..................................................................................................................................3 
1. 
INTRODUCTION ................................................................................................................................... 15 
1.1. 
BACKGROUND .................................................................................................................................... 15 
 
 
1.3. 
RATIONALE FOR CONDUCTING THIS CLINICAL INVESTIGATION ............................................... 16 
2. 
MEDICAL DEVICE OVERVIEW............................................................................................................ 17 
2.1. 
DEVICE UNDER INVESTIGATION ...................................................................................................... 17 
2.2. 
INTENDED PURPOSE .......................................................................................................................... 20 
2.3. 
INTENDED INDICATION FOR USE ..................................................................................................... 20 
 
 
2.5. 
DESCRIPTION OF THE CONTROL DEVICE(S) OR HISTORIC CONTROL ...................................... 23 
2.6. 
DEVICE HANDLING ............................................................................................................................. 23 
3. 
CLINICAL INVESTIGATION OBJECTIVE ........................................................................................... 24 
4. 
CLINICAL INVESTIGATION DESIGN .................................................................................................. 25 
4.1. 
CLINICAL INVESTIGATION PROCEDURES AND FOLLOW-UP SCHEDULE .................................. 25 
4.2. 
MEASURES TAKEN TO AVOID AND MINIMIZE BIAS ....................................................................... 28 
4.2.1. SUBJECT REQUIREMENT .................................................................................................................. 28 
4.2.2. SAFETY MONITORING ........................................................................................................................ 28 
4.2.3. FOLLOW-UP COMPLIANCE ................................................................................................................ 29 
5. 
ENDPOINTS .......................................................................................................................................... 30 
5.1. 
PRIMARY ENDPOINT ........................................................................................................................... 30 
5.2. 
SECONDARY ENDPOINTS .................................................................................................................. 30 
6. 
SUBJECT SELECTION AND WITHDRAWAL ..................................................................................... 31 
6.1. 
SUBJECT POPULATION ..................................................................................................................... 31 
6.1.1. NUMBER OF SUBJECTS ..................................................................................................................... 31 
6.2. 
SUBJECT SCREENING AND INFORMED CONSENT ........................................................................ 31 
6.2.1. SUBJECT SCREENING ........................................................................................................................ 31 
6.2.2. INFORMED CONSENT ......................................................................................................................... 31 
 
 
6.3. 
ELIGIBILITY CRITERIA ........................................................................................................................ 32 
6.3.1. GENERAL ELIGIBILITY CRITERIA ..................................................................................................... 32 
6.3.2. INCLUSION CRITERIA ......................................................................................................................... 32 
6.3.3. EXCLUSION CRITERIA ........................................................................................................................ 32 

 
 
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6.4. 
SUBJECT ENROLLMENT .................................................................................................................... 33 
6.5. 
SUBJECT WITHDRAWAL .................................................................................................................... 33 
6.6. 
EXPECTED DURATION OF THE PARTICIPANTS IN THE CLINICAL INVESTIGATION ................. 34 
6.6.1. SUSPENSION OR EARLY TERMINATION OF THE CLINICAL INVESTIGATION ............................ 34 
7. 
TREATMENT AND EVALUATION OF ENDPOINTS ........................................................................... 35 
7.1. 
BASELINE ............................................................................................................................................. 35 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. 
ADVERSE EVENTS .............................................................................................................................. 38 
8.1. 
DEFINITION........................................................................................................................................... 38 
8.1.1. ADVERSE EVENT ................................................................................................................................ 38 
8.1.2. SERIOUS ADVERSE EVENT ............................................................................................................... 38 
8.1.3. DEVICE DEFICIENCY/DEVICE MALFUNCTION................................................................................. 38 
8.2. 
DEVICE RELATIONSHIP ...................................................................................................................... 39 
8.2.1. UNANTICIPATED (SERIOUS ADVERSE) DEVICE EFFECT [U(S)ADE] ........................................... 39 
8.3. 
ADVERSE EVENT AND DEVICE DEFICIENCY/DEVICE MALFUNCTION REPORTING.................. 39 
8.3.1. ADVERSE EVENT REPORTING .......................................................................................................... 39 
8.3.2. DETERMINATION OF ADVERSE EVENTS RELATED TO DEVICE AND/OR PROCEDURE ........... 40 
8.3.3. UNANTICIPATED SERIOUS ADVERSE DEVICE EFFECT REPORTING TO SPONSOR AND EC . 40 
8.3.4. DEVICE DEFICIENCY/MALFUNCTION REPORTING ........................................................................ 40 
 
 

 
 
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9. 
DATA AND DATA ANALYSIS: STATISTICAL CONSIDERATIONS .................................................. 42 
9.1. 
ANALYSIS POPULATIONS.................................................................................................................. 42 
9.1.1. INTENT-TO-TREAT POPULATION (ITT) ............................................................................................. 42 
9.1.2. PER-PROTOCOL POPULATION (PP) ................................................................................................. 42 
9.2. 
STATISTICAL ANALYSES ................................................................................................................... 42 
9.2.1. PRIMARY SAFETY AND FEASIBILITY ENDPOINT ANALYSES....................................................... 42 
9.3. 
SAMPLE SIZE CALCULATION AND ASSUMPTIONS ....................................................................... 42 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
10. 
QUALITY CONTROL AND QUALITY ASSURANCE .......................................................................... 44 
10.1. 
SELECTION OF CLINICAL SITES AND INVESTIGATORS ............................................................... 44 
10.2. 
CLINICAL INVESTIGATION FINANCES AND AGREEMENTS .......................................................... 44 
 
 
10.4. 
TRAINING.............................................................................................................................................. 44 
10.4.1. SITE TRAINING .................................................................................................................................... 44 
10.4.2. TRAINING REQUIRED FOR THE USE OF THE DEVICE ................................................................... 44 
10.5. 
MONITORING ....................................................................................................................................... 44 
 
 
 
 
 
 
 
 
 
 
11.1. 
PROTECTION OF PERSONALLY IDENTIFIABLE INFORMATION ................................................... 47 
11.2. 
DATA MANAGEMENT PLAN ............................................................................................................... 47 
 
 
11.4. 
CASE REPORT FORM COMPLETION ................................................................................................ 48 
11.5. 
RECORD RETENTION ......................................................................................................................... 49 

 
 
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12.4. 
STEPS TAKEN TO CONTROL OR MITIGATE RISKS ........................................................................ 51 
12.5. 
BENEFIT TO RISK RATIONALE .......................................................................................................... 51 
13. 
ETHICAL CONSIDERATION ................................................................................................................ 52 
13.1. 
ETHICS COMMITTEE AND AEMPS REVIEW AND APPROVAL ....................................................... 52 
14. 
CLINICAL INVESTIGATION CONCLUSION ........................................................................................ 53 
15. 
PUBLICATION POLICY ........................................................................................................................ 54 
APPENDIX I: ABBREVIATIONS AND ACRONYMS ....................................................................................... 55 
 
 
 
 

 
 
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1. INTRODUCTION 
Laparoscopy is defined as a surgical technique that allows surgical procedures to be performed while minimizing 
trauma to the body. These procedures require a small incision in the body, which permits the introduction of a 
video-camera system to help the surgeons perform the surgery1,2. 
 
 
 
Bitrack System is a tele-assisted surgical robot intended to assist in the accurate control of the exclusive Bitrack 
System-compatible range of ESE/NESE (electrosurgical and non-electrosurgical endoscopic) instruments. The 
Bitrack System is composed by a console, a robotic unit and an embedded software. 
 
 
 
The primary objective of this clinical investigation is to evaluate the safety and performance of the Bitrack 
System in patients indicated with robotic assisted laparoscopic Radical/simple nephrectomy surgery. 
 
 
 
This clinical investigation is sponsored by Rob Surgical Systems (Barcelona, Spain) and will be conducted in 
accordance with this CIP. 
 
 
1.1. Background 
Laparoscopic surgeries have become the gold standard for many surgical procedures as they allow minimally 
invasive surgery (MIS) to be performed, thus providing a benefit over an open procedure, including, among 
others, a reduction in post-operative pain, a decrease in the length of hospital stays, a faster return to daily 
activities and improved cosmesis, which increases patients’ quality of life4. New surgical tools, such as the 
development of robotic-assisted surgery (RAS), have been designed to improve the effectiveness of the 
process, minimizing the ergonomic and visualization deficiencies of laparoscopy while preserving the 
advantages of minimally invasive surgery3. 
During minimally invasive robotic surgery (MIRS) procedures, the robots employed are not considered 
autonomous, 
 
 
Nevertheless, decades of continued improvement 
 
 have significantly increased the 
potential for these robots to assist during minimally invasive surgeries6.  
 
 
 
 
 One of the main concerns for surgeons is the absence of haptic sensation; 
however, RAS permits fine and precise movements, as well as the elimination of tremor, which is argued to 
compensate the aforementioned disadvantage. Besides, the robotic platforms used in RAS offer the possibility 
to reduce ergonomic issues by providing a comfortable seating or neutral posture position, avoiding forced 
unnatural movements and delegating the torquing forces to the robotic arms, decreasing the burden on 
surgeon’s muscles in the sensitive areas like the neck, shoulders, and upper back7. 
Medical application of laparoscopic procedures includes a wide range of surgical processes, among which the 
most frequent are gastrointestinal complications, bariatric and metabolic surgeries, and gynecological and 

 
 
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urological applications3,4. 
 
 
 
 
 The European Association of 
Urology indicates that robotic and laparoscopic procedures, such as prostatectomy and partial nephrectomy 
(RNP), are equivalent, 
 
 
 it has been also determined that the use of RAS may improve 
the precision of movements and reduce the risk of damage to the cavernous nerves to maintain erectile function 
by mechanical trauma, traction or thermal energy8,9. 
Bitrack System is a surgical robot indicated to be used during urological surgical procedures, general abdominal 
laparoscopic surgical procedures, and gynecological laparoscopic surgical procedures. This robot is intended 
to assist in the accurate control of endoscopic instruments and accessories for visualization and endoscopic 
manipulation. RAS systems and equipment such as Bitrack System are intended for use in invasive surgical 
procedures, during which patients are potentially most vulnerable to physical harm. 
 
 
 
  
  
 
 
1.3. Rationale for Conducting this Clinical Investigation 
Traditional laparoscopic surgery has been associated with ergonomic issues due to prolonged operative times, 
unnatural body postures, and positioning of trocars. Robotic platforms have been introduced as an option to 
decrease some of these issues. Bitrack System is presented as an open robotic platform designed to improve 
efficiency with regards to current robotic systems, reducing limitations of conventional laparoscopy and robotic 
surgery while maintaining its advantages over the open approach. Additionally, enabling fine and precise 
movements of the surgical instruments results in accurate control of their corresponding endoscopic surgical 
instruments in case of urologic laparoscopic surgical procedures carried out by means of an abdominopelvic 
approach. 
 
 
 
 
 
. 
 
 

 
 
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2. MEDICAL DEVICE OVERVIEW 
 
 
 
 
 
2.1. Device Under Investigation 
Bitrack System is an Open Robotic Platform designed to universalize high precision surgery and improve the 
efficiency on current robotics solutions.  
Hybrid surgery is a new surgical approach that allows for combining minimally invasive surgery (MIS) and 
minimally invasive robotic surgery (MIRS) in the same procedure and to move quickly from MIS to MIRS. 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
Finally, in tele-assisted mode, through the console unit, the console user can take control of the system. The 
system reproduces the user maneuvers (position and orientation) from the console unit manipulators to the 
instrument end-effectors. 
 
 
 
 
. 
 
 
 
 

 
 
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).  
 
 
 
 
 
 
 
  
 
 
  
 
 
 
  
 
 
  
 
 
  
 

 
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  

 
 
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2.5. Description of the Control Device(s) or Historic Control 
No Control Devices or Historic Control are applicable to this study, since there is no direct comparison to other 
competitor devices. 
2.6. Device Handling 
 
 
 
 
 
ESE/NESE instruments will be handled according to the approved Instructions For Use. Prior to use of the 
device, there is a non-sterile manipulation of the devices to remove them from third and secondary packages, 
 
Traceability of all components involved will be present in the corresponding device labels. 
 
 
 

 
 
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3. CLINICAL INVESTIGATION OBJECTIVE 
The purpose of this early feasibility clinical investigation is to evaluate the safety and performance of the Bitrack 
System and its corresponding ESE and NESE instruments and accessories in patients with the indication of a 
robot assisted laparoscopic radical/simple nephrectomy. 
 
 
 

 
 
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4. CLINICAL INVESTIGATION DESIGN 
The study will be conducted as an early feasibility clinical investigation with a single arm, open-label, and non-
randomized design, and will include 3 subjects candidate to a standard of care laparoscopic surgery. 
The clinical investigation will be conducted in 1 center in Spain. Therefore, this clinical investigation will be 
considered as monocentric. The site investigation details are provided below: 
Hospital Clinic de Barcelona 
 
 
 
 
 
The objective of the study is to make a preliminary and exploratory evaluation of the safety and performance of 
the Bitrack System device and its laparoscopic instruments for the first time in humans, 
 
Since the study does not 
include a formal hypothesis and it is an Early Feasibility Study (EFS) as described by Annex I of EN ISO 
14155:2020 on Clinical research with medical devices, the statistical analysis of the sample population is not 
considered applicable. 
 
 
 
 
 
 
 
  
 
4.1. Clinical Investigation Procedures and Follow-up Schedule 
The Clinical Investigation visits will occur as in-clinic visits at Baseline, Procedure, Discharge, 14 and 30-days 
follow-up. 
The Flow Chart and the Follow-up phases of this clinical investigation are described in Figure 4-1 below. 

 
 
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4.2.3. 
 
 
 
 

 
 
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5. ENDPOINTS 
5.1. Primary Endpoint 
The primary safety and performance endpoints of this early feasibility investigation are: 
1. 
Evaluation of the safety of the Bitrack System by measuring the occurrence of Procedure-Related 
Adverse Events (PRAEs) and Serious Adverse Events (SAEs) during the procedure and through the 
30 days post-procedure period of enrolled patients indicated for robot assisted laparoscopic 
radical/simple nephrectomy. 
2. 
Evaluation of the performance of the investigational devices by means of its ability to access and reach 
the target zone, perform all relevant surgical tasks and to be withdrawn efficiently without conversion to 
MIS or open surgery. The performance of the Bitrack System and the ESE/NESE instruments will be 
analyzed through the conversion rate to conventional laparoscopy/open surgery.  
5.2. Secondary Endpoints 
The secondary endpoints planned for this clinical investigation are listed below: 
 
All AE(s) events during the procedure and through the 14- and 30-days post-procedure will also be 
assessed, and therefore relationship with the investigational device and/or procedure will be examined 
by the principal investigator and reported to Rob Surgical 
o 
Timeframe: Procedure, discharge, 14- and 30 -days follow up visits 
 
Individual safety (i.e., absence of unwanted injure of any tissue) and performance (VAS scale 0-10 
following the subjective surgeon´s opinion, being 0 a non-functional tool and 10 an instrument that works 
exactly equivalent to the surgeon´s hands) for each instrument surgical function. 
o 
Timeframe: Procedure 
 
Blood Loss defined as estimated mL of blood loss, transfusion rates and use of haemostasis agents 
o 
Timeframe: Procedure 
 
Operative Time Procedure measurement for the different tasks. 
o 
Timeframe: Procedure 
 
To evaluate post-operative pain in patients through the Cumulative Analgesic Consumption Score 
(CACS) during the first week (7days) post-procedure. 
o 
Timeframe: Discharge 
 
To assess the duration of subject’s hospitalization as the Length of Stay (LoS) in hospital calculated 
from day of admission to day of discharge. 
o 
Timeframe: Discharge 
 
Patient pain assessment via VAS. Patient interview questions 
o 
Timeframe: Discharge, 14- and 30-days post-procedure 
 
Post-procedure complication rates, including the measurement of the comprehensive complication 
index (CCI) on a scale from 0 (no complications) to 100 (death), and the Clavien-Dindo classification, 
which consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V), the first one indicating any deviation from the 
normal postoperative course, the highest-grade indicating death 
o 
Timeframe: Discharge,14 and 30 days follow-up 

 
 
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6. SUBJECT SELECTION AND WITHDRAWAL  
6.1. Subject Population 
This clinical investigation will enroll male and female subjects between 18-90 years old candidates to a 
radical/simple laparoscopic nephrectomy for benign/malignant pathology. 
 
 
  
6.1.1. 
Number of Subjects  
A total of 3 subjects will be enrolled in the clinical investigation.   
6.2. Subject Screening and Informed Consent 
6.2.1. 
Subject Screening 
Potential patients presenting at the clinical sites will be fully informed about the clinical investigation, following 
the established Informed Consent process (described in section 6.2.2). The Principal Investigator or designee 
previously trained to the CIP will revise patient´s eligibility according to the inclusion/exclusion criteria. Patients 
meeting general inclusion criteria and no exclusion criteria will be asked to sign an Informed Consent form if 
they agree to participate in the clinical investigation. 
 
  
 
 
 
  
Subject data will be collected following enrollment into the clinical investigation. 
6.2.2. 
Informed Consent 
The Investigator or his/her authorized designee (if applicable) will conduct the Informed Consent process, as 
required by applicable regulations and the center’s EC. 
 
 
 
 
 
Withdrawal from the clinical investigation will not jeopardize their future medical care or relationship with the 
investigator.  
During the discussion, the Principal Investigator or his/her authorized designee will avoid any improper influence 
on the subject and will respect subject’s legal rights. Financial incentives will not be given to the subject.
 
 
 
. The subject shall have adequate time 
to review, ask questions, and consider participation. 
 
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participate, the Informed Consent form must be signed and dated by the subject and thereafter by the person 
obtaining the consent prior to any clinical investigation-specific procedures. 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
6.3. Eligibility Criteria 
6.3.1. 
General Eligibility Criteria 
Assessment for general eligibility criteria is based on medical records of the site and interview with a candidate 
patient. If some of the clinical and laboratory tests are not included in site standard tests, they must be done but 
after written informed consent is obtained. Patients must meet ALL of the inclusion criteria to be considered for 
the clinical investigation. If ANY of the exclusion criteria are met, the patient is excluded from the clinical 
investigation and cannot be enrolled. 
6.3.2. 
Inclusion Criteria 
1. Adult subjects between 18 and 90 years old 
2. Subjects must provide written informed consent prior to any clinical investigation related procedure 
3. Subjects who have been scheduled for a laparoscopic radical/simple nephrectomy  
4. Ability and willingness to comply with all study requirements to be evaluated for each study visit 
6.3.3. 
Exclusion Criteria 
1. Pregnant or breastfeeding women at the time of the surgery 
2. Inability to adhere to study-related procedures 
3. Subject has known allergy to some of the device components (i.e., stainless steel, etc.) 

 
 
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4. Subjects who participate in another trial which may affect the outcome data on this study or the ability 
to complete the follow up requirements 
5. Subjects not suitable to undergo MIS/MIRS, according to medical criteria 
6. Subjects with life expectancy inferior to 3 months 
7. Subjects with a BMI ≥ 40. 
8. Subjects with severe cardiopulmonary or coronary artery disease, bleeding disorders or that have been 
submitted to multiple prior operations. 
9. Subjects with abuses of active substances or with uncontrolled psychiatric disorders. 
10. Subjects scheduled for surgeries intended to be in direct contact with the heart, the central circulatory 
system or the central nervous system. 
11. Subjects with any contraindication for the use of the Bitrack System and the ESE/NESE instruments, 
as specified in the Instructions For Use 
6.4. Subject Enrollment 
 
For the HYROS study, a patient is considered enrolled in the clinical investigation from the 
moment they provide written informed consent, has been confirmed to meet all inclusion criteria and none of 
the exclusion criteria and has been successfully treated with the Bitrack System.  
 
 
  
6.5. Subject Withdrawal 
Each enrolled subject shall remain in the clinical investigation until completion of the required follow-up period; 
however, a subject’s participation in any clinical investigation is voluntary and the subject has the right to 
withdraw at any time without penalty or loss of benefit. 
 
 
 
  
 
  
 
 
 
 
 
 
  
 
 
 
 
 

 
 
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6.6. Expected Duration of the Participants in the Clinical Investigation 
 
 
 Subjects´ participation in the clinical investigation will be finalized at the 
conclusion of their 30 days follow-up visit. 
 
 
.  
6.6.1. 
Suspension or Early Termination of the Clinical Investigation 
While no formal statistical rule for early termination of the clinical investigation for insufficient effectiveness of 
the device under investigation is defined, the Sponsor reserves the right to discontinue the clinical investigation 
at any stage or reduce the follow-up period with suitable written notice to the investigator. Possible reason(s) 
may include, but are not limited to: 
 
Unanticipated adverse device effect (e.g.,UADE) occurs and it presents an unreasonable risk to the 
participating subjects. 
 
An oversight committee (e.g., Steering/Executive Committee, Data Monitoring Committee) makes 
a recommendation to stop or terminate the clinical investigation (such as higher frequency of 
anticipated adverse device effects). 
 
Further product development is cancelled. 
Should the clinical investigation be discontinued by the Sponsor, subjects will be followed per routine hospital 
practice with device-related AEs reported to the Sponsor as per vigilance/commercial reporting requirements. 
 
 
 
 
 
  
 
 
 
 
 
 
 
 

 
 
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7. TREATMENT AND EVALUATION OF ENDPOINTS 
7.1. Baseline 
7.1.1. 
Baseline Clinical Assessments 
During the baseline visit, in those subjects who have signed the informed consent form and meet all the inclusion 
and none of the exclusion criteria, the following medical assessments will be performed, as required by the 
clinical investigation design: 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
7.2. Randomization 
No randomization process will take place in this clinical investigation.  
7.3. Blinding 
This is an open-label clinical investigation. Investigators and subjects will not be blinded to the procedure 
assignment. 
7.4. Index Procedure 
The robotic assisted laparoscopic radical/simple nephrectomy surgery will be performed a maximum of 4 weeks 
after Baseline visit and up to the surgeon criteria and patient´s agreement. The dates of the following visits are 
calculated starting from the day this visit took place. 
 
 
7.4.1. 
Procedures Involved in the Use of the Devices Under Investigation 
For further information about the investigational devices, their components and their intended use and 
applications, refer to the IFU. 
7.4.2. 
 
 
  
 
 
 
 

 
 
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 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
7.5. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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8. ADVERSE EVENTS 
 
 
.  
8.1. Definition 
8.1.1. 
Adverse Event 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
medical device under investigation. 
Note 1: This definition includes events related to the medical device under investigation or the comparator. 
Note 2: This definition includes events related to the procedures involved. 
Note 3: For users or other persons, this definition is restricted to events related to medical devices under 
investigation. 
8.1.2. 
Serious Adverse Event 
If the AE meets any of the criteria below, it is regarded as a serious adverse event (SAE).  
a) Led to a death, 
b) Led to a serious deterioration in health of the subject, that either resulted in  
1. a life-threatening illness or injury, or 
2. a permanent impairment of a body structure or a body function, or 
3. in-patient hospitalization or prolongation of existing hospitalization, or 
4. medical or surgical intervention to prevent life threatening illness or injury or permanent 
impairment to a body structure or a body function. 
5. chronic disease  
c) Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
Note: A planned hospitalization for pre-existing condition, or a procedure required by the CIP, without a serious 
deterioration in health, is not considered to be an SAE. 
8.1.3. 
Device Deficiency/Device Malfunction 
Device deficiency is defined as an inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety or performance, such as malfunction, misuse or use error and inadequate labeling. This 
includes the failure of the device to meet its performance specifications or otherwise perform as intended. Note: 
Performance specifications include all claims made in the labeling of the device. 
A device malfunction is the failure of a device to meet its performance specifications or otherwise perform as 
intended, when used in accordance with the instructions for use or CIP. 

 
 
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9. DATA AND DATA ANALYSIS: STATISTICAL CONSIDERATIONS 
 
 
 
 
9.1. Analysis Populations 
9.1.1. 
Intent-to-treat Population (ITT) 
The intent-to-treat population (ITT) includes all adult humans derived for a robot assisted laparoscopic 
Radical/simple nephrectomy surgery using Bitrack System and its sterile endoscopic surgical instruments 
medical devices, in whom treatment using the device under investigation is attempted but not achieved.    
9.1.2. 
Per-Protocol Population (PP) 
Per-Protocol Population (PP) includes all subjects who fulfill the inclusion criteria, do not meet any exclusion 
criteria, have signed the informed consent form (ICF), and have undergone to a robotic assisted radical/simple 
nephrectomy surgery using Bitrack System medical device. 
 
. 
9.2. Statistical Analyses  
9.2.1. 
Primary Safety and Feasibility Endpoint Analyses 
The primary safety and performance endpoints of this early feasibility investigation are: 
1) 
Evaluation of the safety of the Bitrack System by measuring the occurrence of Procedure-Related 
Adverse Events (PRAEs) and Serious Adverse Events (SAEs) during the procedure and through the 14-days 
and 30-days post-procedure period of enrolled patients indicated for robot assisted laparoscopic Radical/simple 
nephrectomy surgery.  
2) 
Evaluation of the performance of the investigational devices by means of its ability to access and reach 
the target zone, perform all relevant surgical tasks and to be withdrawn efficiently without conversion to MIS or 
open surgery. 
Considering the low number of subjects, no formal hypothesis has been defined for this clinical investigation. 
 
 
 
9.3. Sample Size Calculation and Assumptions 
HYROS is a feasibility study performed as an exploratory clinical investigation, to determine the limitations and 
advantages of Bitrack System, to capture information in order to freeze the design of the medical device and to 
progress to the validation stage. In this sense, only three patients are considered for this clinical investigation 
and consequently statistical considerations do not apply 
 
 

 
 
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10. QUALITY CONTROL AND QUALITY ASSURANCE 
10.1. 
Selection of Clinical Sites and Investigators 
The Sponsor will select investigators qualified by training and experience to participate in the clinical 
investigation. 
 
 
10.2. 
Clinical Investigation Finances and Agreements 
The clinical investigation will be financed by Rob Surgical Systems, S.L. 
 
 
 
 
  
 
  
 
 
10.4. 
Training 
10.4.1. 
Site Training 
All Investigators and clinical investigation personnel are required to attend Sponsor training sessions, which 
may be conducted at an Investigator's meeting, a site initiation visit, or other appropriate training sessions. Over-
the-phone or self-training may take place as required. 
 
 
 
 
 
 
  
10.4.2. 
Training Required for the Use of the Device 
Bitrack System is to be used by professionals who have been previously trained in MIS procedures. 
 
 
 
 
 
10.5. 
Monitoring 
Sponsor and/or designee will monitor the clinical investigation over its duration according to the CIP-specific 
monitoring plan which will include the planned extent of source data verification. This monitoring plan will be a 
separate document that can be updated during the curse of the study.  
  

 
 
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 
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
 
10.6. 
Deviations from CIP 
The Investigator should not deviate from the CIP for any reason except in cases of medical emergencies when 
the deviation is necessary to protect the rights, safety and well-being of the subject or eliminate an apparent 
immediate hazard to the subject. In that event, the Investigator will notify Sponsor immediately by phone or in 
writing.  
 
 
 
 
  
 
  
 
 
 
 
 
 
 
 
 
  
 
 
 
  
 
 
 
 
 
 

 
 
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11.1. 
Protection of Personally Identifiable Information 
The Sponsor respects and protects personally identifiable information collected or maintained for this clinical 
investigation.  
 
 
 
 
 
The Sponsor requires the investigational sites to transfer into Sponsor’s data management systems only 
pseudonymous Personal Information (key-coded) necessary to conduct the Clinical Investigation, such as the 
patient’s medical condition, treatment, dates of treatment, etc. 
 
 
 
 
 
 
 
 
 
  
The Sponsor maintains a Privacy Incident procedure that complies in all respects with Applicable Law and 
industry best practices. 
11.2. 
Data Management Plan 
A Data Management Plan (DMP) will describe procedures used for data entry and collection. Data review and 
data cleaning, and issuing, resolving data discrepancies and methods for data base lock. 
 

 
 
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11.4. 
Case Report Form Completion 
Primary data collection based on source-documented hospital and/or clinic chart reviews will be performed 
clearly and accurately by site personnel trained on the CIP and CRF completion. 
 
 
 
   
 
 

 
 
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11.5. 
Record Retention 
The Sponsor and Investigator/Site will archive and retain all documents pertaining to the clinical investigation 
as per the applicable regulatory record retention requirements, but at least for 15 years. 
 
 
 
 
 
 
 
 
 
  
 
  
 
 

 
 
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12.4. 
Steps Taken to Control or Mitigate Risks 
Risks associated with the use of surgical robots are well established and can be extensively minimized by the 
use of a good technique and experience/training. 
12.5. 
Benefit to Risk Rationale 
 
 
 
 
 
 
 
 
. 
The benefit that the device provides overweight the residual risks, at this stage of the design.  
 
 
 
 
 
                                                     
1
 

 
 
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13. ETHICAL CONSIDERATION 
13.1. 
Ethics Committee and AEMPS Review and Approval 
Ethics Committee (EC) and Spanish Agency of Medicines and Medical Products (AEMPS) approval for the CIP 
and ICF/other written information provided to the patient will be obtained at each investigational site prior to 
consenting and enrolling patients in this clinical investigation. The approval letter must be received prior to the 
start of this clinical investigation and a copy must be provided to the Sponsor.  
 
  
 
  
 
  
 
 
 
 

 
 
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14. CLINICAL INVESTIGATION CONCLUSION 
The clinical investigation will be concluded when: 
 
Site is closed AND 
 
The final report has been provided to investigators or the Sponsor has provided formal documentation 
of clinical investigation closure.  
 
 
  
 

 
 
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15. PUBLICATION POLICY 
The data and results from the clinical investigation are the sole property of the Sponsor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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