A Single-Center, Prospective, Single Arm Study to Evaluate the Performance of the Auris Robotic Endoscopy System for Bronchoscopic Procedures
Phase: NA
Conditions: Lung Cancer
Sponsor: Auris Health, Inc.

Official title: Auris Robotic Endoscopy System (ARES) for 
Bronchoscopy 
NCT number: NCT03497026 
Document date: 5 October 2017 

 
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TITLE PAGE 
Auris Robotic Endoscopy System (ARES) for 
Bronchoscopy – NSR Study 
 
STUDY TITLE: 
Auris Robotic Endoscopy System (ARES) for 
Bronchoscopy – NSR Study 
A SINGLE-CENTER, PROSPECTIVE, SINGLE ARM STUDY TO EVALUATE THE 
PERFORMANCE OF THE AURIS ROBOTIC ENDOSCOPY SYSTEM (ARES) FOR 
BRONCHOSCOPIC PROCEDURES 
 
PROTOCOL: 
PRT DD082015 
VERSION: 
9 
DATE: 
October 5, 2017 
 
 
Revision History 
 
Version 
Description of Change 
3 
Released for IRB Submission (provided to ECH Coordinator) 
4 
Revised list of Risks to match ICF (Page 13-14 Section 1.2.1) 
5 
Clarified bronchoscopic risk (Page 14 Section 1.2.1) 
6 
Resolve protocol inconsistencies and make revisions to match ICF 
7 
Revised protocol to reflect anticipated product development and to 
clarify study endpoints 
8 
Included the final device description and clarified study endpoints 
9 
Resolve inconsistency with primary and secondary endpoint 
 
 
 

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ARES Bronchoscopy Study 
  CONFIDENTIAL    
  October 5, 2017   
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Clinical Investigation Plan (CIP) and Protocol 
Identification of Responsibility Page 
Auris Robotic Endoscopy System (ARES) for 
Bronchoscopy – NSR Study 
A SINGLE-CENTER, PROSPECTIVE, SINGLE ARM STUDY TO EVALUATE THE PERFORMANCE OF THE AURIS ROBOTIC
ENDOSCOPY SYSTEM (ARES) FOR BRONCHOSCOPIC PROCEDURES 
(PTL DD082015) 
The Study will be performed in accordance with the relevant parts of Title 21 CFR Parts 812, 50, 54, 56 and ISO 
14155-1 / 14155-2.1; the ICH Guidelines for Good Clinical Practices (E6), the Declaration of Helsinki, and any 
regional and/or national regulations 
Sponsor: 
Auris Surgical Robotics, Inc 
 
Principal Investigators / 
 
 
 
 
 
 
 
 
 
 
Date of Issue: 
October 5, 2017 Version 9 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation.  It should be held 
confidential and maintained in a secure location. 
Do not copy or distribute without written permission. 

 
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Protocol Synopsis 
Auris Robotic Endoscopy System (ARES) for 
Bronchoscopy – NSR Study 
A SINGLE-CENTER, PROSPECTIVE, SINGLE ARM STUDY TO EVALUATE THE PERFORMANCE OF THE AURIS ROBOTIC 
ENDOSCOPY SYSTEM (ARES) FOR BRONCHOSCOPIC PROCEDURES 
Primary Objective 
The objective of this study is to evaluate the performance of the novel 
Auris Robotic Endoscopy System (ARES) during bronchoscopy procedures.  
Product features may be added and/or revised during the conduct of the 
study and will be evaluated by the physician. Appropriate notifications to 
Institutional Review Board (IRB) will be made of any revisions. The study is 
a Non-Significant Risk (NSR) feasibility study with no specific statistical 
study size or power. 
Test Device 
Monarch Robotic Endoscopy Platform, the next generation of Auris Robotic 
Endoscopy System (ARES) 
Control Device 
None 
Indication 
for Use 
 
510K #: K152319 
The previous ARES is FDA cleared medical device (510K #: K152319) 
intended to provide bronchoscopic visualization of patient airways. The 
Auris Robotic Endoscopy System (ARES) is intended to be used by qualified 
physicians to provide visualization to the bronchial tree during 
bronchoscopic procedures. 
 
The Monarch Robotic Endoscopy Platform (Monarch Platform) and its 
accessories are intended to provide bronchoscopic visualization of and 
access to patient airways for diagnostic and therapeutic procedures. 
 
Hypotheses 
No formal statistical hypotheses are defined.  It is believed that the Auris 
system will be capable of enhancing access to peripheral lung lesions. 
Study Design 
A single-center, prospective, single arm study to evaluate the performance 
related to the use of the ARES during bronchoscopic procedures.  The Auris 
system will be used in conjunction with a navigational bronchoscopy 
procedure.  
Number of Patients 
The study will enroll up to 60 patients. It is expected that enrollment will 
take up to 6 months. 

 
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Sites 
 
 
 
 
 
 
 
 
 
Duration of Study 
Each enrolled subject will be followed up to 6 weeks (± 7 days) post 
procedure. 
Primary 
Effectiveness 
Endpoint 
The primary effectiveness endpoint is the completion of the intended 
bronchoscopic procedure with the ARES, as defined by the ability to 
acquire tissue with biopsy tools. 
Secondary 
Effectiveness 
Endpoints 
The following will be considered secondary endpoints: 
• Identification of correct bronchi leading to the targeted lesions 
• Ability to localize targeted lesion 
• Alignment capabilities 
• Time to REBUS confirmation (lesion localization), time to the tissue 
acquisition confirmation, Total procedure time (from introduction 
to removal of the bronchoscope) and procedure interruptions 
• Diagnostic yield 
• Conversion to conventional bronchoscopic procedure 
• Anesthesia time 
 
Primary Safety 
Endpoint 
Device or procedure related adverse events (AEs). 
Secondary Safety 
Endpoint 
Complications unrelated to device. 
Follow-Up Schedule 
Each enrolled subject will be followed up to 6 weeks ±7 days post 
procedure. 

 
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Pre-Operative 
Inclusion Criteria 
1. 18 to 80 years of age; 
2. Capable and willing to give informed consent; 
3. Acceptable candidate for an elective, non-emergent bronchoscopic 
procedure; 
4. Solid peripheral lung lesions suspected of malignancy, between 1.5-7cm 
in size identified on thin slice CT scan with 30 days of the intended 
bronchoscopy 
Pre-Operative 
Exclusion Criteria 
Subjects will be excluded from participating in this Study if they meet any 
of the following criteria prior to initiation of the endoscopic procedure: 
1. Medical contraindication to bronchoscopy; 
2. Ground glass opacity lesions on pre-procedure CT 
3. Participation in any other clinical trial 30 days before and throughout 
the duration of the study; 
4. Uncontrolled or irreversible coagulopathy; 
5. Female subjects who are pregnant or nursing or those of child-bearing 
potential refusing a pregnancy test; 
6. CT scan done over a month before the bronchoscopy procedure. 
Intra-Procedure 
Exclusion Criteria 
Any presenting condition discovered intra-procedurally that in the opinion 
of the investigator would make participating in this study not in the 
patient’s best interest. 
 
 

 
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Study Sponsorship 
Sponsor 
 
 
 
 

 
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TABLE OF CONTENTS 
TITLE PAGE .................................................................................................................................. 1 
Identification of Responsibility Page .......................................................................................... 2 
Auris Robotic Endoscopy System (ARES) for Bronchoscopy – NSR Study .................................. 3 
Approval Page ............................................................................................................................. 3 
ARES study – Investigator’s Signature Page................................................................................ 4 
Protocol Synopsis ........................................................................................................................ 5 
TABLE OF CONTENTS................................................................................................................... 9 
1. 
Introduction ....................................................................................................................... 12 
1.1. 
Non-Significant Risk (NSR) Rationale .......................................................................... 13 
1.2. 
Specific Risk and Benefits ........................................................................................... 14 
1.2.1. Risks ....................................................................................................................... 14 
1.2.2. Benefits ................................................................................................................. 16 
2. 
Study Device Description ................................................................................................... 16 
2.1. 
Auris Robotic Cart ....................................................................................................... 16 
2.2. 
Auris Tower ................................................................................................................. 17 
2.3. 
Bronchoscope ............................................................................................................. 19 
2.4. 
Auris Robotic Cart External Components ................................................................... 20 
Fluidics Control .................................................................................................................. 20 
Electro-Magnetic Field generator ..................................................................................... 20 
Reference Electro-Magnetic sensors ................................................................................ 20 
Device Labeling .................................................................................................................. 20 
3. 
Prior Investigation ............................................................................................................. 20 
3.1. 
ARES Biocompatibility Study ....................................................................................... 21 
3.2. 
Bronchoscopy In-vivo Pre-Clinical Study .................................................................... 21 
3.3. 
Ureteroscopy Clinical Pilot Study ............................................................................... 22 
3.4. 
Bronchoscopy Clinical Pilot Study ............................................................................... 23 
4. 
Study Objective .................................................................................................................. 23 
5. 
Study Design ...................................................................................................................... 24 
5.1. 
Overview ..................................................................................................................... 24 
5.2. 
Sample Size ................................................................................................................. 24 
5.3. 
Investigational Site ..................................................................................................... 24 
6. 
Study Population ............................................................................................................... 26 
6.1. 
Selection Criteria......................................................................................................... 26 
6.1.1. Pre-Procedure Inclusion Criteria .......................................................................... 26 
6.1.2. Pre-Procedure Exclusion Criteria ......................................................................... 26 
6.1.3. Intra-Operative Exclusion Criteria ....................................................................... 26 
6.2. 
Withdrawal of Subjects ............................................................................................... 27 

 
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7. 
Written Informed Consent ................................................................................................ 27 
8. 
Study Procedures and Enrollment ..................................................................................... 27 
8.1. 
Duration of Subject Participation ............................................................................... 27 
8.2. 
Enrollment .................................................................................................................. 27 
8.3. 
Assessment Schedule ................................................................................................. 27 
8.4. 
Methods and Procedure ............................................................................................. 30 
8.5. 
Post Bronchoscopy ..................................................................................................... 31 
8.6. 
Follow-up .................................................................................................................... 31 
8.7. 
Study Exit .................................................................................................................... 31 
9. 
Assessment of Device Performance .................................................................................. 31 
9.1. 
Primary Effectiveness Endpoint .................................................................................. 32 
9.2. 
Secondary Effectiveness Endpoints ............................................................................ 32 
9.3. 
Primary Safety Endpoint ............................................................................................. 33 
9.4. 
Secondary Safety Endpoint ......................................................................................... 33 
10. Statistical Considerations .................................................................................................. 33 
11. Data Management – Data Collection and Processing ....................................................... 33 
12. Monitoring Procedures ...................................................................................................... 33 
12.1. Monitoring .................................................................................................................. 33 
12.2. Device Distribution and Accountability ...................................................................... 34 
12.2.1. Device Distribution ............................................................................................... 34 
12.2.2. Device Accountability ........................................................................................... 34 
12.2.3. Return of Materials Upon Study Termination ..................................................... 34 
13. Quality Control and Quality Assurance ............................................................................. 35 
13.1. Site Training ................................................................................................................ 35 
13.2. Physician Training ....................................................................................................... 35 
13.3. Audits and Inspections ................................................................................................ 35 
14. Adverse Events .................................................................................................................. 35 
14.1. General ....................................................................................................................... 35 
14.2. Reporting of Serious and Non-Serious Adverse Events .............................................. 37 
14.2.1. General Reporting Requirements (Serious & Non-Serious Adverse Events) ..... 37 
14.3. Device Failures and Malfunctions ............................................................................... 38 
15. Ethical Considerations ....................................................................................................... 38 
15.1. Study Conduct & the Declaration of Helsinki ............................................................. 38 
15.2. Institutional Review Board/Ethics Committee ........................................................... 38 
15.3. Informed Consent Form.............................................................................................. 39 
15.4. Amending the Protocol ............................................................................................... 39 
15.5. Emergency Actions ..................................................................................................... 39 
15.6. Protocol Deviations ..................................................................................................... 39 
15.7. Coverage of Expenses ................................................................................................. 40 
15.8. Confidentiality ............................................................................................................ 40 

 
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16. Study Administration ......................................................................................................... 41 
16.1. Pre-Study Documentation Requirements .................................................................. 41 
16.2. Source Documentation ............................................................................................... 41 
16.3. Record Retention ........................................................................................................ 41 
16.4. Criteria for Terminating Study .................................................................................... 42 
16.5. Criteria for Suspending/Terminating a Study Center ................................................. 42 
16.6. Investigator Responsibilities ....................................................................................... 42 
17. Publication Policy ............................................................................................................... 43 
18. Regulatory Considerations ................................................................................................ 43 
18.1. Role of Auris Surgical Robotics ................................................................................... 43 
18.2. General Duties [21 CFR 812. 40] ................................................................................. 44 
18.3. Monitoring [21 CFR 812. 46] ....................................................................................... 44 
18.4. Supplemental Applications [21 CFR 812. 335 (A) and (B)] ......................................... 44 
18.5. Maintaining Records [21 CFR 812. 140 (B)] ................................................................ 44 
18.6. Submitting Reports [21 CFR 812. 150 (B)] .................................................................. 44 
18.7. Site Record Retention Policy [21 CFR 812. 140 (D)] ................................................... 44 
18.8. Informed Consent & Institutional Review Board (IRB) [21 CFR Parts 50 & 56] .......... 45 
19. Abbreviations and Definitions ........................................................................................... 45 
19.1. Abbreviations .............................................................................................................. 45 
19.2. Definitions ................................................................................................................... 45 
19.3. Bibliography ................................................................................................................ 47 
20. Attachment 1: Investigator Responsibilities, Records and Reports .................................. 48 
20.1. Investigator Responsibilities ....................................................................................... 48 
20.2. Investigator Records ................................................................................................... 48 
20.3. Investigator Reports ................................................................................................... 48 
21. Attachment 2: Sample Informed Consent Form ............................................................... 50 
22. Attachment 3: Instructions For Use (IFU) .......................................................................... 51 
23. Attachment 4: Declaration of Helsinki .............................................................................. 52 
 
 
 

 
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1. Introduction  
Lung cancer is the leading cause of cancer deaths in the United States, having a higher mortality 
than prostate, colon, and breast cancers combined. Approximately 220,000 patients are newly 
diagnosed with lung cancer each year and over 155,000 patients die from the disease annually in 
the United States.1 
Recently, the National Lung Screening Trial found that 24% of high-risk patients who underwent 
low-dose computed tomography (CT) scans had lesions suspicious for lung cancer.2  
As the technology to identify lesions improves and screening for lung cancer in at-risk individuals 
advances, there will be increased requirements for minimally invasive tissue diagnosis of these 
lesions.  
The early and accurate diagnosis of lung cancer is critical. However, many peripheral lung lesions 
are beyond the reach of conventional bronchoscopes. Additionally, alternative techniques, such 
as CT-guided or surgical biopsy, can carry increased risks to the patient. Diagnostic yield of flexible 
bronchoscopy is limited by its inability to guide biopsy instruments directly to the lesion. Varying 
technologies have been proposed to guide endobronchial biopsies, such as electromagnetic 
navigation, endobronchial ultrasound (EBUS) and computed tomography fluoroscopy.3 However, 
the correlation of real-time guidance and the ability to precisely direct a biopsy instrument is 
critical to biopsy success.  
Over the past two decades there has been extensive development of “robotic” medical device 
systems that result in “intuitive” or instinctive control of medical devices providing enhanced 
stability and control.  The term “robotic”, in this case, refers not to autonomous movement but 
rather electromechanical, software driven control by the physician operator.  Typically, these 
“robotic” systems remain under continuous and direct control by the physician operator.  Good 
examples of these robotic devices include Intuitive Surgical’s “da Vinci” surgical control system 
and Hansen Medical’s catheter control system. 
All of these control systems, both surgical and interventional, are classified by the United States 
Food and Drug Administration (FDA) as Class II devices with at most moderate risk and are subject 
to the “Pre-Market Notification” or “510(k)” clearance process.  FDA has historically determined 
these devices to be similar enough to their conventional manual device counterparts that a 
“substantial equivalence” determination can be made.  Thus, these devices have historically been 
excluded from the more rigorous “Pre-Market Approval” or PMA process used for Class III devices 
found by FDA to carry higher risk. 
The Auris Robotic Endoscopic System (ARES) is a “robotic” or electromechanical, software driven 
endoscopy system designed to be used by qualified physicians to provide visualization to the 
bronchial tree during bronchoscopic procedures and, therefore, to guide a bronchoscope and 
associated tools to predetermined points within the bronchial tree.  FDA has cleared the previous 
 
1 Jemal A, Siegel R, Xu J, Ward E. Cancer Statistics 2010. Ca Cancer, J Clin 2010;60:277–300.   
2 Aberle R, Adams AM, Berg CD, et al. National lung screening trial research team. Reduced lung-cancer mortality with low-dose 
computed tomographic screening. N Engl J Med 2011;365:395–409.   
3 Gilbert C, Akulian J, Ortiz R, Lee H, Yarmus L. Novel bronchoscopic strategies for the diagnosis of peripheral lung lesions: 
present techniques and future directions. Respirology. 2014 Jul;19(5):636-44.   

 
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ARES, like the Intuitive Surgical and Hansen Medical devices, as a Class II device under the 510(k)-
clearance process (510K #: K152319).  Further, FDA has classified endoscopes in general as being 
“non-significant risk” or NSR devices (see below). 
The ARES has been extensively tested in porcine and cadaver studies.  The system has been also 
tested in a clinical pilot studies in humans to remove urinary stones and in a separate study to 
obtain lung biopsy specimens.  Herein, we propose a clinical trial with this enhanced 
bronchoscopic system to provide visualization to the bronchial tree during bronchoscopic 
procedures and, therefore, to guide a bronchoscope and associated tools to obtain diagnostic 
tissue from bronchopulmonary lesions suspicious of malignancy. 
1.1. Non-Significant Risk (NSR) Rationale 
FDA defines a “Significant risk device” as an investigational device that: (1) is intended as an 
implant and presents a potential for serious risk to the health, safety, or welfare of a subject; (2) 
is for use in supporting or sustaining human life and represents a potential for serious risk to the 
health, safety, or welfare of a subject; (3) is for a use of substantial importance in diagnosing, 
curing, mitigating, or treating disease or otherwise preventing impairment of human health and 
presents a potential for serious risk to the health, safety, or welfare of a subject; or (4) otherwise 
presents a potential for serious risk to a subject.  Examples of Significant risk devices include 
sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants (see copy of FDA 
guidance attached).  Studies of devices that pose a significant risk require both FDA and an 
Institutional Review Board (IRB) approval prior to initiation of a clinical study.  FDA approval is 
obtained by submitting an IDE application to FDA (§812.20). 
Non-significant risk (NSR) devices are devices that do not pose a significant risk to the human 
subjects.  An NSR device study requires only IRB approval prior to initiation of a clinical study.  
Sponsors of studies involving NSR devices are not required to submit an IDE application to FDA 
for approval.  In the attached guidance document, FDA lists several specific endoscopes as 
examples of NSR devices.  The listed endoscopes include: 
• Conventional Gastroenterology and Urology Endoscopes and/or Accessories  
• Conventional Laparoscopes, Culdoscopes, and Hysteroscopes  
Based upon these examples and the NSR definition, Auris Surgical Robotics believes that the ARES 
when used in the referenced study clearly falls into the NSR category.   
In addition, we consider this clinical study and the system under investigation to fall into the 
category of non-significant risk for patients whom meet the selection criteria for several reasons:  
• 
The ARES is not implanted.  The system is only used to guide and steer an endoscope.  
Instruments inserted through the working channel of the endoscope during endoscopic 
procedures are not included in this study and will be conventional endoscopic tools used in 
standard-of-care procedures to perform specific tasks such as biopsy.  Because of its small, 
flexible, atraumatic design, the Auris bronchoscope clearly does not present a potential for 
serious risk to the health, safety, or welfare of a subject. The biopsy alternative method 
called transthoracic needle aspiration (TTNA) to obtain lung tissue biopsies is the use of a 
long needle to penetrate through the chest wall into the lung to access the target lesion.  

 
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Transthoracic needle aspiration has a substantial 25% pneumothorax rate and 5% 
pneumothorax rate requiring a chest tube.  The bronchoscopic technique does not penetrate 
the chest wall and therefore significantly decreases the co-morbidity profile.  
• 
The ARES is not used in supporting or sustaining human life and therefore, again does not 
represent a potential for serious risk to the health, safety, or welfare of a subject. 
• 
The ARES is not of substantial importance in diagnosing, curing, mitigating, or treating 
disease during these studies because standard-of-care tools will be used to perform any 
diagnostic or therapeutic procedures.  Specifically, conventional endoscopic tools are used 
to perform any diagnostic or therapeutic treatments, e.g., obtain biopsy specimens.  At no 
time is the ARES used to guide patient treatment. 
• 
The protocol was developed in concert with the study’s investigator who is well-known in 
the area of interventional pulmonology.  In addition, 
 has had multiple training 
sessions with the ARES and will have additional time and instruction with the system.  The 
site, El Camino Hospital, was chosen because of the proven track record and expertise in the 
field of interventional pulmonology. 
• 
The environment or room to be used for this proposed procedure will provide careful usage 
(non-chaotic as oppose to an emergency room) of the system with the additional option to 
revert to a standard manual bronchoscope if any issues develop during the procedure with 
the ARES.  This environment will include proper personnel in the room including the 
investigators and bronchoscopy nurses.  Company representatives will also be present for 
each procedure, in order to provide optimal support for each case using the ARES. 
• 
The Auris development team involved with this system has the breadth and experience on 
working on medical devices.  The ARES was both designed by an experienced team of 
individuals that have over 10 decades of cumulative experience bringing both medical and 
robotic devices to the market. The ARES was developed in compliance with guidelines 
outlined in ISO 13485, including but not limited to Risk Analysis, Design Control and both 
Design Verification and Validation Activities. As such, the ARES has been validated to work 
as designed for the clinical investigation. 
• 
ARES was evaluated in a human pilot study that focused on guidance of standard of care 
tools for the biopsy of suspicious lesions. This study was completed in October of 2014 and 
biopsied 15 patients. No cases of pneumothorax were reported from the study.  There were 
three adverse events reported in the study.  All three adverse events were non-serious with 
unrelated causality to the system use. 
In the light of these facts, it is the opinion of Auris Surgical Robotics that the system used within 
the criteria of this study protocol is a non-significant risk to the patients whom meet the selection 
criteria. 
1.2. Specific Risk and Benefits 
1.2.1. 
Risks 
With any bronchoscopic procedure, there is the possibility of the following risks listed in the 

 
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order of estimated frequency.1 Below risks are related only to bronchoscopy procedure and 
not for biopsy:  
• Common: Between 1 and 5% 
• Shortness of breath 
• Coughing 
• Wheezing 
• Rare:  Between 0.1 and 1% 
• Bleeding/Hemoptysis 
• Lung Leak or Collapse 
• Infection/Pneumonia 
• Transitory Fever 
• Extremely Rare:  Less than 0.1% 
• Bronchoscopic Airway Puncture 
• Cardiovascular Event/Irregular heartbeat 
• Bronchial Asthma 
• Respiratory Failure 
• Death 
In the event that any of these were to occur, the study subject will be treated for the 
condition. Some subjects may experience wheezing, coughing, or shortness of breath 
during the first few days following a bronchoscopy procedure. 
Anesthesia Risk 
There is a potential risk of developing side effects associated with the use of anesthesia. 
The risks of anesthesia depend on the agents and/or gases used. The risks of anesthesia 
include postoperative pain, nausea and vomiting, dizziness, drowsiness, shivering, liver 
toxicity and/or cardiovascular events. Trained professionals with extensive experience 
and expertise who routinely administer local anesthesia with conscious sedation to 
patients requiring multiple procedures will be responsible for the induction and associate 
monitoring required for this study. In addition, study patients will undergo extensive 
monitoring throughout the recovery period. 
Risk Mitigation 
Risks during study participation will be minimized by the following:   
The study protocol was developed with an investigator that is well-known in the area of 
interventional pulmonology.  The site was chosen because of proven expertise in the field 
of interventional pulmonology.  All Investigators performing the procedure using the 
ARES System under the clinical protocol will undergo a Training Program, which includes 
elements of both a didactic and training program.  Proficiency must be demonstrated 
prior to use in humans.  
 has had several days of training time with the system 
 
1 FUMIHIRO ASANO, et al., Deaths and complications associated with respiratory endoscopy:  A survey by the Japan Society for Respiratory Endoscopy in 
2010 Respirology (2012) 17, 478–485 

 
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and has demonstrated proficiency with the system.  Pre-clinical, in vitro and in vivo testing 
has been performed in order to optimize the device safety and function. 
1.2.2. 
Benefits 
The primary potential benefit of participation is the occurrence of a successful biopsy of tissue 
for pathological evaluation which is necessary to support specific treatment. Results will be 
evaluated in this study and will further support the development of bronchoscopic equipment 
for pulmonary and thoracic physicians. 
2. Study Device Description 
Monarch Robotic Endoscopy Platform, the next generation of Auris Robotic Endoscopy System 
(ARES), consists of three major components, the Auris Robotic Cart (ARC), the Tower and the 
Robotic Endoscope.  The current system is the next iteration of the Auris Robotic Endoscopy 
System (ARES) that originally received 510(k) clearance as a Class II device in May 2016. The 
system has several components that interface to the Auris Robotic Cart including: The Fluidics 
Control, Electro-Magnetic Field generator, and Reference Electro-Magnetic sensors. 
 
2.1. Auris Robotic Cart 
 
The Auris Robotic Cart (ARC) is a carrier for the robot arms. It includes two robotic arms which 
contain rotary pulleys to actuate the drive cables in the bronchoscope. The Cart houses the 
electronic systems required to power and operate the robotic system. Automated lift controls 
will raise and lower the height of the robotic arms. The cart handle allows the cart to be 
maneuvered so that the cart wheels can be directionally locked. An embedded touch-screen on 
the cart handle provides feedback during system setup.  
An Emergency Stop button (Estop) sits on the Auris Robotic Cart and is positioned such that a 
clinical assistant has easy access to it. 
The following image shows the Auris Cart with the robotic arms in the stow position (right) and 
load bronchoscope position (left): 
 

 
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Figure 1. Auris Robotic Cart 
 
2.2. Auris Tower 
The Auris Tower houses two computers that run the system, a Non-Real Time Computer and a 
Real-Time Computer. The Non-Real Time computer takes the inputs from the pendant, 
keyboard, mouse, camera, EM Localization/Targeting System and Power Distribution Unit.  
The Non-Real Time computer also contains an interface to the micro camera at the tip of the 
Endoscope. The camera interface performs the necessary image processing and generates 
output video streams.  
The robotic system algorithms are also implemented on the Real-Time computer. The Real-
Time computer receives inputs from the Non-Real Time computer.  The network handles 
communication between the two computers, robotic arms and Power Distribution Unit. 
The tower provides connectivity for the bronchoscope camera and lighting, as well as the fluidics 
system. 
A single monitor is integrated into the Tower to display real time video captured from the 
bronchoscope camera overlaid with information on the status of the robotic system. Lastly, an 
E-stop sits on the Auris Tower and is positioned such that a clinician has easy access to it.  
The following image show the Tower: 

 
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Figure 2. Auris Tower 
The Tower includes an endoscopy controller that allows the clinician to control the system 
during a procedure. On the controller, two joysticks are used to drive and articulate the 
bronchoscope while various buttons are used to control irrigation, aspiration and the device 
state. The following image shows the endoscopic controller: 
 
 

 
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Figure 3. Auris Endoscopy Controller 
2.3. Bronchoscope 
 
The Auris Bronchoscope is a comprised of two collinear and concentric devices, the inner 
scope and the outer sheath both of which possess 4-way steering control. This 
configuration enables the capability of telescoping, which enhances the bronchoscope 
stability and access capability.  
 
Figure 4. Auris Robotic Endoscope 
Bronchoscope 
Sheath 

 
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The bronchoscope includes a camera that provides the operative perspective, an integrated 
light source in the scope handle and a 2.1 mm inner diameter working channel for the passing 
of tools.  
The scope and sheath has a distal section capable of achieving articulation in pitch, yaw and 
any combination of the two to enable precise control while driving the bronchoscope. 
Proximally, the scope is equipped with a valve to facilitate the insertion and sealing of various 
ancillary devices, such as a biopsy needle. Additionally, the proximal section routes irrigation 
and aspiration to the shared working channel. 
 
2.4. Auris Robotic Cart External Components 
 
The system has several components that interface to the Auris Robotic Cart including: 
Fluidics Control, Electro-Magnetic Field generator, and Reference Electro-Magnetic sensors. 
 
Fluidics Control 
The fluidics control consists of a peristaltic pump and controlled valves.  The fluidics 
control can dispense a fluid through a single-use tubing set into the endoscope.  The 
fluidics control actuates aspiration of fluids to an external vacuum source. 
Electro-Magnetic Field generator 
The Electro-Magnetic Field generator is used as part of the system for navigation 
guidance.   
Reference Electro-Magnetic sensors 
The Reference Electro-Magnetic sensors are used to monitor the patient position relative 
to the Electro-Magnetic Field Generator.  
 
 
 
 
Device Labeling 
A copy of the Instructions for Use (IFU) will be included with the devices. 
 
3. Prior Investigation 
 

 
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The ARES System, has undergone careful and comprehensive in-vivo and ex-vivo pre-clinical 
studies.  The system was developed under 21 CFR 820 design control compliant design control 
process.  The safety and performance of the ARES system was also successfully used in humans 
for ureteroscopic applications in 16 human patients and for bronchoscopic applications in 15 
human patients. 
Summaries of previous investigations are presented below. 
3.1. ARES Biocompatibility Study 
Title: Testing for Externally Communicating Devices 
Completed: (Available Upon Request) 
Objective: To evaluate the biocompatibility of the appropriate components of the ARES 
Methods: The tests that were performed are listed in the table below. 
 
Biocompatibility Tests for External Communicating Devices 
Cytotoxicity: MEM Elution 
Completed, Passes 
Sensitization: Local Lymph Node Assay 
Completed, Passes 
Irritation: Intracutaneous Reactivity 
Completed, Passes 
 
Conclusions: All of these tests will be concluded prior to the start of the robotic procedures.  The  
study investigators will be updated on the outcome or justifications of these evaluations. 
 
3.2. Bronchoscopy In-vivo Pre-Clinical Study 
 
Title: Acute Evaluation of the Auris Robotic Endoscopic System (ARES) for Bronchoscopy 
Start/Complete dates:  2/20/2014 to 5/01/2014 
Objectives: 
o To acutely evaluate the following in bronchi in vivo in porcine models: 
 The safety profile of the procedure 
• Document any adverse events or findings 
 The performance of the Auris system 
• Navigation 
o Visual 
o Movement 
 Biopsy 

 
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 To evaluate the ability for an operator/physician to 
consistently/accurately control and navigate in an animal 
bronchial tree 
Results: 
o Number of animals 
 10 
o Biopsy evaluation 
 Successful use of both biopsy forceps and needle aspiration 
devices 
o Navigation 
 Successful robotic navigation throughout the bronchial tree 
o Safety 
 One pneumothorax 
• The physician user was navigating without vision and 
testing peripheral reach of the ARES system. 
 Emergency removal successful 
Conclusion 
o Operators/physicians can be trained to successfully navigate throughout the 
bronchial tree with the ARES system. 
o The ARES system appears to be safe with proper usage including navigation 
with vision 
o The ARES system appears to provide a means for successful tissue biopsy using 
forceps and needle aspiration devices 
 
3.3. Ureteroscopy Clinical Pilot Study 
 
Title:  Robotic Endoscopy Pilot Study for the treatment of Renal Calculi 
Start/Complete dates: 6 to 10 June 2014 
Objectives/Study Design: 
o The primary objective of this study is to evaluate the safety and 
performance of the ARES for the treatment of renal and/or ureteral calculi. 
o This is an unblinded, single-arm, single site study. 
o The study was approved by the ethics committee at the Muljibhai Patel 
Urological Hospital. 
Results 
o 16 patients 
 24 stones removed 
o Safety 
 No surgical or post-operative complications 
Conclusions 
o Operators/physicians can be trained to successfully navigate 
throughout the bronchial tree with the ARES system. 

 
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o The ARES system appears to be safe with proper usage including 
navigation with vision 
o There were no unanticipated adverse events from the procedure 
 
3.4. Bronchoscopy Clinical Pilot Study 
 
Title:  Performance and safety evaluation of a robotic bronchoscopy system for diagnosis of 
suspected lung cancer:  A Clinical Pilot Study 
Start/Complete dates:  13 September 2014 to 5 October 2014 
Objectives: 
o The primary objective of this study is to evaluate the safety and 
performance of the ARES for the access of suspicious lung cancer 
lesions 
o This is an unblinded, single-arm, single site study 
o The study was approved by the ethics committee at the Hospital Clínica 
Bíblica and WIRB (Western Institutional Review Board) 
Results 
o 15 patients 
 Enrolled/completed the study 
 Able to navigate and biopsy from 15 of the 15 (100%) study 
procedures 
o Safety 
 No surgical or post-operative complications 
Conclusions 
o Operators/physicians can be trained to successfully navigate 
throughout the bronchial tree with the ARES system. 
o There were no unanticipated adverse events from the procedure 
 
4. Study Objective 
 
The objective of this study is to evaluate the performance of the Monarch Robotic Endoscopy 
Platform, the next generation of Auris Robotic Endoscopy System (ARES) during bronchoscopy 
procedures.  Information obtained during this feasibility study may be used to guide future 
product development. 
Product features may be added and/or revised during the conduct of the study and will be 
evaluated by the physician.  The IRB will be kept informed of any product revisions as appropriate. 
The study is a NSR feasibility study with no specific statistical study size or power. 

 
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5. Study Design 
5.1. Overview 
A single-center, prospective, single arm study to evaluate the performance of the ARES System 
during bronchoscopy procedures.  The Auris system will be used in conjunction with a 
navigational bronchoscopy procedure.   
 
5.2. Sample Size 
The study will enroll up to 60 patients. 
It is expected that enrollment will take up to 6 months.  
5.3. Investigational Site 

 
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Figure 5.  
Schematic of Study Design 

 
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6. Study Population 
 
6.1. Selection Criteria 
The following pages outline the specific inclusion and exclusion criteria for the study. Before 
study enrollment, a patient must meet all of the inclusion and none of the exclusion criteria. 
6.1.1. 
Pre-Procedure Inclusion Criteria 
All subjects are required to meet the following inclusion criteria in order to be considered 
eligible for participation in this Study: 
Pre-Operative 
Inclusion Criteria 
1. 18 to 80 years of age; 
2. Capable and willing to give informed consent; 
3. Acceptable candidate for an elective, non-emergent Bronchoscopic 
procedure; 
4. Solid peripheral lung lesions suspected of malignancy, between 1.5-
7cm in size identified on thin slice CT scan with 30 days of the 
intended bronchoscopy 
6.1.2. 
Pre-Procedure Exclusion Criteria 
Subjects will be excluded from participating in this Study if they meet any of the following 
exclusion criteria prior to initiation of the endoscopic procedure. 
Pre-Operative 
Exclusion Criteria 
1. Medical contraindication to bronchoscopy; 
2. Ground glass opacity lesions on pre-procedure CT 
3. Participation in any other clinical trial 30 days before and throughout 
the duration of the study; 
4. Uncontrolled or irreversible coagulopathy; 
5. Female subjects who are pregnant or nursing or those of child-bearing 
potential refusing a pregnancy test; 
6. CT scan done over a month before the bronchoscopy procedure. 
6.1.3. 
Intra-Operative Exclusion Criteria 
Subjects will be excluded from participating in this Study if any of the following exclusion 
criteria occur during the endoscopic procedure: 
 
Intra-Procedure 
Exclusion Criteria 
Any presenting condition discovered intra-procedurally that in the 
opinion of the investigator would make participating in this study not in 
the patient’s best interest. 
 

 
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6.2. Withdrawal of Subjects 
While study withdrawal is discouraged, patients may withdraw from the study at any time, with 
or without reason and without prejudice to further treatment.  In all cases of withdrawal, the 
reason(s) for withdrawal (if given) will be recorded upon study termination. 
In addition, the investigator may withdraw the subject due to any of the following situations: 
• adverse event 
• any other reason determined by the investigator to be in the best interest of the 
subject. 
Subjects withdrawn from the Study prior to insertion of the ARES should be converted to 
conventional bronchoscopy.  Subjects withdrawn due to an adverse event should be followed 
until the event has been resolved or is stable, if at all possible.  
7. Written Informed Consent  
Written Informed Consent must be obtained for all patients who are potential study candidates 
before any study-specific tests or procedures are performed. 
Patients who meet general entry criteria will be asked to sign the study-specific, Institutional 
Review Board (IRB) -approved Informed Consent form before any study-specific tests or 
procedures are performed. Study personnel should explain that even if a patient agrees to 
participate in the study and signs an informed consent form, the ARES may demonstrate that the 
patient is not a suitable candidate for the study.  
A Screening/Enrollment Log will be maintained to document select information about candidates 
who fail to meet the entry criteria.  
8. Study Procedures and Enrollment 
 
8.1. Duration of Subject Participation 
Once the subject has completed 6 weeks (±1 week) follow-up without study related adverse 
events requiring further follow-up, subject will be exited from the study. 
8.2. Enrollment 
Subjects that meet the pre-operative inclusion/exclusion criteria will be invited to participate in 
the Study and sign the IRB approved informed consent form.  All subjects must provide written 
informed consent before undergoing any study related activity. 
8.3. Assessment Schedule 
The following page outlines the required study assessments. 
 
 

 
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Table 1. 
Schedule of Assessments 
Test/Parameter 
Screening/ 
Baseline 
Pre-
Procedure 
Procedure 
Discharge 
Follow-up 
24±12 
hours 
Follow-
up 7±3 
days 
Follow-
up 6±1 
weeks 
Informed Consent 
x 
 
 
 
 
 
 
Pregnancy Test (if applicable) 
x 
 
 
 
 
 
 
Preliminary Qualification 
(inclusion/exclusion criteria) 
x 
 
 
 
 
 
 
Medical History (pulmonary 
status) 
x 
 
 
 
 
 
 
Physical examination 
x 
 
 
x 
 
ECG 
x 
 
 
 
 
 
 
Blood test and coagulation 
test (PT/INR)1 
x 
 
 
 
 
 
HRCTScan2 
x 
 
 
 
 
 
 
Fluoroscopy3 
 
 
x 
 
 
 
 
Radial probe Endobronchial 
ultrasound (REBUS) 4 
 
 
X4 
 
 
 
 
Chest X-ray5 
 
 
X5 
 
 
 
Concomitant medications6 
x 
x 
 
 
 
 
 
Follow-up Form  
 
 
 
x 
x 
x 
x 
Navigation/control evaluation 
 
 
x 
 
 
 
 
Biopsy sample evaluation 
 
 
x 
 
 
 
 
1 A blood test including the PT/INR coagulation test will be assessed before the procedure. 
2 The procedure will take place within 30 days of CT scan for participation in the study. 
3 Fluoroscopy will be used in conjunction to provide an additional viewing method during the procedure. 
4 REBUS will be used to confirm the presence of a lesion in patients where additional confirmation is needed. 
5 Chest X-ray within 2 hours from the conclusion of the procedure. 
6 Aspirin and clopidogrel will be stopped one week before procedure. Oral anticoagulants will be stopped at least 5 
days before and coagulations tests will be performed before procedure. Anticoagulants will be restarted 24 hours 

 
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after procedure if no bleeding persists. Subcutaneous anticoagulants will be stopped 24 hours before and restarted 
24 hours after procedure if no bleeding persists. 
 
 
Informed Consent.  A study specific, IRB approved written informed consent must be 
obtained for all patients who are potential study candidates before any study-specific 
tests or procedures are performed. 
Pregnancy Test (if applicable).  If there is the potential for pregnancy, a serum pregnancy 
test will be conducted before entry into the study. 
Preliminary qualification (Inclusion/Exclusion criteria).  Principal Investigator is 
responsible for certifying that key personnel have received adequate training to ensure 
they are aware of the regulations governing human subjects research and understand and 
adhere to the IRB-approved research protocol. Compliance with these standards provides 
assurance that the rights, safety, and well-being of human subjects are protected and the 
integrity of the data collected. Potential study candidates must meet the study specific 
Inclusion/Exclusion criteria based on the screening assessment. For the purpose of this 
study, a peripheral lung lesion is defined as a lesion located in a sub segmental branch of 
the bronchial tree that it cannot be accessed by convex probe endobronchial ultrasound.   
Medical history.  During the screening/baseline assessment, the investigator or 
coordinator will record details of medical history as they relate to pulmonary status. 
Physical examination.  The investigator will perform a brief, directed physical and 
pulmonary examination and document any preoperative abnormalities.  The examination 
will be repeated at the day 7 post-procedure. 
Electrocardiogram (ECG).  Stickers will be placed on each arm and leg and to your chest 
area and a heart tracing is performed to measure electrical activity of your heart. 
Blood tests including the PT/INR coagulation test. These tests may be needed before the 
procedure to ensure that study patients have no problems related to blood clotting.  (see 
above). Bleeding can sometimes occur after bronchoscopy, especially if tissue samples 
are taken. The study patients will be asked to stop anticoagulants several days prior to 
the procedure (see Table 1. above). 
HRCT scan.  CT analysis will require a full inspiratory CT scan.  CT Scans should be 
performed no longer than 30 days pre-procedure as part of screening assessment. 
Specific CT parameters for scanner model and manufacturer will be provided to the site. 
De-identified CT scans may be provided to the study sponsor. 
Fluoroscopy. Fluoroscopy will be used in conjunction with the bronchoscopy to provide 
an additional viewing method during the procedure. 
Radial probe endobronchial ultrasound (REBUS). REBUS will be used to confirm the 
presence of a lesion in patients where additional confirmation may be needed. 

 
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Chest X-ray.  Patients will undergo a routine chest X-ray within 2 hours from the 
conclusion of the procedure to o rule out complications such as pneumothorax. 
Concomitant 
Medications. 
Principal 
investigator 
will 
determine 
relevant 
disease/procedure specific concomitant medications that is important for a study 
conduct. Only the relevant medication will be recorded on a rolling medication log or the 
relevant case report forms.  
Follow-up.  The 24 hours (±12 hours) follow-up will be a phone consultation, 7 days (±3 
days) follow-up will be an office visit and 6 weeks ((±1 week) follow-up will be a phone 
consultation. During the follow-up, adverse events will be recorded and associated case 
report forms will be completed. 
 
Navigation/Control evaluation.  The system navigation/control will be evaluated and 
recorded on the procedure CRFs. 
Biopsy sample evaluation.  Content and adequacy of biopsy samples will be assessed by 
pathologist or cytotechnologists using the rapid on-site evaluation (ROSE).  A preliminary 
diagnosis will be recorded. The final histopathologic diagnosis will be recorded on the 
week 6 follow-up CRF. 
8.4. Methods and Procedure 
If a technical malfunction of the ARES was to occur, a conventional bronchoscope will be used at 
the discretion of the investigator. The study procedure may be recorded with an external video 
camera for educational purposes only. 
 
Bronchoscopy:  
Sedation: General anesthesia will be administered by an anesthesiologist per standard care at El 
Camino Hospital in a dedicated bronchoscopy suite.  Patients will be continuously monitored 
throughout the procedure as per standards practices at El Camino Hospital. 
Airway inspection: When adequate sedation has been given, the bronchoscope (BF-P190, 
Olympus, Tokyo, Japan) will be inserted into the tracheobronchial tree through endotracheal 
tube and a standard airway inspection will be performed. 
Robot-assisted bronchoscopy: Following standard airway inspection, the robotic system will be 
positioned in an operative position. A study investigator will connect the sterile robotic 
bronchoscope to the light source and camera box, manually inserted the bronchoscope into the 
endotracheal tube and attached it to the robot. Then, the investigator will remotely advance the 
bronchoscope into the bronchial tree using the endoscope controller and will navigate it into the 
targeted lobar segment using EM navigation. In addition to direct visualization, monoplanar 
fluoroscopy may be used to provide additional viewing method during all procedures. 

 
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REBUS:  Once the bronchoscope was positioned within 2 cm from the targeted lesion, REBUS 
probe will be passed to confirm localization of a targeted lesions. The REBUS images will be 
recorded and classified as either concentric or eccentric. 
TBNA and Biopsy:  An aspiration needle will be first inserted into the working channel and 
advanced along the same pathway to the lesion.  Four needle aspirations will be performed from 
the targeted lesion. Secondly, four biopsies will be performed using forceps and acquired samples 
will be placed in formalin. 
ROSE:  Needle aspiration samples will be plated on slides for immediate on-site evaluation by the 
cytopathology team, as per the standard practice of the Interventional Pulmonology team at El 
Camino Hospital. Rapid on-site evaluation (ROSE) of acquired cytologic specimen will be 
performed in all cases.  
ROSE diagnostic: If ROSE provides a definitive diagnosis, the procedure will be completed.  
ROSE non-diagnostic: If ROSE does not provide a definitive diagnosis, conventional bronchoscopy 
will be performed. 
Conventional Bronchoscopy:  In cases in which ROSE using a robotic bronchoscope does not 
provide a definitive diagnosis, a conventional bronchoscopy using standard EM navigation may 
be used. 
 
8.5. Post Bronchoscopy 
Prior to hospital discharge, all subjects will be evaluated for adverse events.  These data will be 
captured in the Case Report Forms. The patient will be managed post-operative in a dedicated 
post-procedure area as per standard practices at El Camino Hospital.  The subject will be 
monitored for postoperative symptoms and will undergo a chest X-ray within 2 hours from the 
conclusion of the procedure, to rule out complications such as pneumothorax. Prior to hospital 
discharge, the investigator and/or designee will arrange a follow-up appointment. 
8.6. Follow-up 
The subject will have a follow-up phone call on day 1 post procedure (24 hours ±12 hours), a 
follow-up appointment in the clinic 7 days post-procedure ± 3 day and the final phone call follow-
up 6 weeks ± 7 days post-procedure. 
8.7. Study Exit 
Once the subject has completed 6 weeks follow-up or has withdrawn, they should be exited from 
the Study provided they do not have any conditions that require continued follow-up.  The date 
of exit and subject status will be recorded on the Study Completion Form. 
9. Assessment of Device Performance 
 

 
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9.1. Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the completion of the intended bronchoscopic procedure 
as defined by the ability to acquire tissue with biopsy tools. 
Ability to acquire tissue with biopsy tools: The sum of ARES results that were positive for tissue 
acquisition divided by the sum of all targets. 
9.2. Secondary Effectiveness Endpoints 
The following will be considered secondary endpoints: 
• Identification of correct bronchi leading to the targeted lesions 
• Ability to localize targeted lesion 
• Alignment capabilities 
• Time to REBUS confirmation (lesion localization), time to the tissue acquisition 
confirmation, Total procedure time (from introduction to removal of the 
bronchoscope) and procedure interruptions 
• Diagnostic yield 
• Conversion to conventional bronchoscopic procedure 
• Anesthesia time 
Identification of correct bronchi leading to the targeted lesions: The principal investigator will 
assess the capabilities of the ARES navigation to identify optimal path to the targeted lesion. 
 
Ability to localize targeted lesion: Radial probe endobronchial ultrasound will be used in all 
cases to confirm the presence of a lesion immediately before performing biopsy. 
Alignment capabilities: The sum of ARES results that were positive for the first attempt of tissue 
acquisition divided by the sum of all attempts. 
Time to REBUS confirmation: Is defined by the time the ARES bronchoscope is inserted into the 
oropharynx until the localization of the targeted lesion is confirmed by REBUS. 
Time to the tissue acquisition confirmation: Is defined by the time the ARES bronchoscope is 
inserted into the oropharynx until the tissue acquisition is confirmed by the ROSE. 
Total procedure time: Total procedure time is defined by the time the ARES bronchoscope is inserted 
into the oropharynx until the time a biopsy tool is removed. 
Diagnostic yield: =
𝑎𝑎+𝑏𝑏
𝑛𝑛 where 
• 
a = the sum of ARES results that were diagnostically positive for malignancy at 6-week follow-up 
• 
b = the sum of the ARES results that were diagnostically negative for malignancy at 6-week 
follow-up 
• 
n = the sum of all targets 
 
Conversion to conventional bronchoscopic procedure: If ROSE does not provide a definitive 
diagnosis in 4 attempts, the conventional bronchoscopy will be used to acquire additional 
specimens. 

 
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Number of the procedure converted to the conventional bronchoscopy for any reason. 
 
 
9.3. Primary Safety Endpoint 
Device related adverse events (AEs) 
9.4. Secondary Safety Endpoint 
Complications unrelated to device. 
10. Statistical Considerations 
None 
11. Data Management – Data Collection and Processing 
Standardized CRFs will be utilized by participating site using a standardized database.  
Conventional paper-based CRFs will be used and send to a sponsor designee via secure encrypted 
emails.  Investigator is responsible for the accurate completion and timely submission of the data 
collected during the Study.  Incoming data will be monitored by the sponsor or designee to 
identify inconsistent or missing data and any adverse events.  Any data issues are to be promptly 
addressed with the investigator.  Quality assurance procedures will be established to ensure that 
complete, accurate and timely data are submitted, that protocol requirements are followed and 
that complications, adverse events and adverse device effects are correctly reported and 
investigated, as appropriate.  Investigator is to maintain all source documents as required by the 
protocol, including laboratory results, supporting medical records, and signed Informed Consent 
forms.  The source documents will be used during the regular monitoring visits to verify 
information from the database against data contained on the completed CRFs.  
The Principal Investigator must maintain detailed records on all subjects who sign the Informed 
Consent and begin the pre-procedure evaluation.  Data for enrolled subjects will be entered into 
CRFs provided by the Sponsor.  All data should be entered completely, promptly and legibly.  For 
source documents, corrections should be made in a manner that does not obscure or eliminate 
the original error, by striking through the original data with one line, and initialing and dating the 
change, along with the reason for the change (if not obvious).   
Study Exit CRFs are completed for all enrolled subjects, regardless if they did or did not complete 
the Study (e.g., subject discontinuation, Study termination). 
12. Monitoring Procedures 
12.1. Monitoring 
Monitoring visits to the clinical sites will be made periodically during the study by the 
Sponsor’s 
designee 
to 
ensure 
that 
all 
aspects 
of 
the 
current, 
approved 
protocol/amendment(s) are followed. Original source documents will be reviewed for 
verification of data in the database. The Investigator/institution guarantees direct access to 

 
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original source documents by Auris Surgical Robotics, Inc. personnel, their designees, and 
appropriate regulatory authorities. In the event that the original medical records cannot be 
obtained for a patient that is seen by a non-study physician at a non-study institution, 
photocopies of the original source documents must be made available for review. 
It is important that the Investigator and relevant study personnel are available during the 
monitoring visits and that sufficient time is devoted to the process. 
Phone contacts and site visits will be conducted to ensure that the protocol is being followed 
and that any protocol deviations are properly documented.  Clinical monitoring will include a 
verification that Informed Consent was properly obtained for all enrolled study participants, 
a review of clinical records for accuracy and completeness, resolution of missing or 
inconsistent results and a review of source documents.  The clinical monitor will verify that 
the Case Report Forms (CRFs) are in agreement with the source documentation and other 
records.  The investigator will make available to the clinical monitor for review all Informed 
Consent documents, source documentation, original laboratory data and other relevant 
records for all enrolled subjects at the site.  It is important that the investigator and other 
relevant site personnel are available for consultation with the clinical monitors during the 
monitoring visits and that sufficient time is devoted at the site to the monitoring process. 
Additionally, telephone and/or e-mail contact will be conducted on a regular basis with the 
investigator and the site staff to ensure that the protocol is being followed and to address 
any issues that may occur during the course of the Study. 
If a deficiency is noted during an on-site visit (or at any other time during the course of the 
Study), the clinical monitor is required to discuss the situation with the investigator and the 
Sponsor (if required) to secure compliance. 
12.2. Device Distribution and Accountability 
12.2.1. 
Device Distribution 
Auris Robotic Endoscopy System (ARES) for Bronchoscopy will be provided free of charge 
to the investigator for his exclusive use in this NSR study.  
12.2.2. 
Device Accountability 
Auris Surgical Robotics will maintain device accountability as required for this NSR 
Study. 
12.2.3. 
Return of Materials Upon Study Termination 
The Auris Robotic Endoscopy System (ARES) for Bronchoscopy will be returned at the end 
of the study. 

 
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13. Quality Control and Quality Assurance 
13.1. Site Training 
To ensure accurate, complete, and reliable data, the Sponsor or its representatives will provide 
instructional material to the Study sites, as appropriate;  
• Instruct the Investigators and Study personnel on the protocol, the completion of the 
CRFs, and Study procedures 
• Communicate regularly with site personnel via mail, email, telephone, and/or fax 
• Make periodic visits to the Study sites. 
During those visits, the sponsor’s designee will monitor the subject data recorded in the CRFs 
against source documents at the Study site. 
13.2. Physician Training 
Prior to enrolling subjects in the Study, investigators will be provided didactic training on the 
procedural steps required to use the ARES system.  Physicians who have not previously used the 
device will receive training with a Sponsor-designated proctor using a benchtop model to 
simulate the use of the ARES system. 
13.3. Audits and Inspections 
The Principal Investigator for the site will inform the Sponsor or the Sponsor’s designee in 
advance if they are to be audited or inspected by any regulatory agencies.  The Sponsor or the 
Sponsor’s designee will also inform the site if they are made aware of a pending audit or 
inspection by a regulatory agency.  No FDA inspections are expected to be associated with this 
NSR Study. 
14. Adverse Events 
14.1. General  
All adverse events (AE) and serious adverse events (SAE) will be monitored from the time of 
enrollment through the end of follow-up.  
An AE is defined as any undesirable clinical occurrence in a patient whether or not it is considered 
to be device related. In addition, the definition of AE applies to any event with an onset post 
study procedure or to any underlying diseases, present at baseline, that exacerbate in severity 
post study procedure. Therefore, an underlying disease that was present at the time of 
enrollment is not reported as an AE, but any increase in the severity of the underlying disease is 
to be reported as an AE. All reported AEs must be recorded in the database. A description of the 
event, including the start date, resolution date, action taken, and the outcome should be 
provided, along with the Investigator’s assessment of the relationship between the AE, the study 
treatment and the study procedure. 
The following definitions for rating severity of adverse events will be used: 

 
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Mild: 
Awareness of signs or symptoms, but easily tolerated; are of minor 
irritant type; causing no loss of time from normal activities; symptoms 
would not require medication or a medical evaluation; signs or symptoms 
are transient. 
Moderate: 
Interferes with the subject’s usual activity and/or requires symptomatic 
treatment. 
Severe: 
Symptom(s) causing severe discomfort and significant impact of the 
subject’s usual activity and requires treatment. 
A serious adverse event (SAE) is defined as an event which leads to:   
• 
Death due to any cause 
• 
Life-threatening condition 
• 
Results in persistent or significant disability/incapacity 
• 
Requires in-patient hospitalization or prolonged hospitalization 
• 
Necessitates an intervention to prevent a permanent impairment of a body function 
or permanent damage to a body structure 
• 
Results in congenital abnormality 
 All SAE’s will be reported. 
Device-Related Adverse Event: an adverse event is considered to be device-related when, in the 
judgment of the Investigator, the clinical event has a reasonable time sequence associated with 
use of the AURIS ROBOTIC ENDOSCOPY SYSTEM (ARES) and is unlikely to be attributed to concurrent 
disease or other procedures or medications.  It is reasonable to believe that the system directly 
caused or contributed to the adverse event.  
Procedure-Related Adverse Event: an adverse event is considered to be procedure-related when, 
in the judgment of the Investigator; it is reasonable to believe that the event is associated with the 
assigned study procedure and is not specific to the AURIS ROBOTIC ENDOSCOPY SYSTEM (ARES) used.  
Other products, surgical techniques, or medications required specifically for the procedure are 
likely to have contributed to the occurrence of the event. 
Concomitant Medication-Related Adverse Event: an adverse event is considered to be 
concomitant medication related when, in the judgment of the Investigator, it is reasonable to 
believe that the event is associated with concomitant medications used in conjunction with the 
AURIS ROBOTIC ENDOSCOPY SYSTEM (ARES) and is not otherwise specific to the AURIS ROBOTIC ENDOSCOPY 
SYSTEM (ARES) (e.g. bleeding associated with anticoagulation medication). 
Pre-Existing Condition-Related Adverse Event: an adverse event is considered to be related to a 
pre-existing condition when, in the judgment of the Investigator, it is reasonable to believe that 
the event is associated with the subject’s pre-existing condition and is not specific to the AURIS 
ROBOTIC ENDOSCOPY SYSTEM (ARES) or procedure. Pre-existing conditions that are aggravated or 
become more severe during or after the procedure should be evaluated on a case-by-case basis to 

 
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determine if the event may be more appropriately classified as device-related or procedure-
related. 
Auris Surgical Robotics, Inc., or its designee, in cooperation with the Investigator, will assess all 
adverse events considered to be device-related for potential reportability to the FDA and other 
regulatory authorities as an Unanticipated Adverse Device Effect (UADE).  
The Investigator should follow all unresolved serious adverse events until the events are resolved, 
the subject is lost to follow-up, the subject has withdrawn consent, or the adverse event is 
otherwise explained. 
For purposes of this study, the following events are not likely to be device-specific adverse events, 
because they are typical procedure/anesthesia related adverse events normally expected to occur in 
conjunction with these types of bronchoscopic procedures / post-procedure, or are associated with 
customary, standard care of subjects undergoing these procedures: 
• Any pre-planned surgical procedures 
• Bleeding 
• Pneumothorax 
• Post-procedure respiratory insufficiency 
This listing of events is intended to provide guidance to the investigational sites for purposes of adverse 
event reporting.  The Investigator at the investigational site should utilize his/her own clinical judgment 
in evaluating adverse experiences, and may decide that the above events should be reported as adverse 
events.   
14.2. Reporting of Serious and Non-Serious Adverse Events  
14.2.1. 
General Reporting Requirements (Serious & Non-Serious Adverse Events) 
All serious and potentially device- and/or procedure-related adverse events must be 
recorded on the Adverse Event CRF by the Investigator (or designee).  The report should 
include: severity, duration, action taken, treatment outcome and relationship of the adverse 
experience to the study device, procedure, concomitant medications, pre-existing condition, 
etc. (i.e., unrelated, related or relationship unknown).   
In the case of serious adverse events, procedure and/or device observations and 
malfunctions, medical record documentation (e.g. procedure notes, operative notes, 
discharge summary, relevant progress notes, imaging or lab studies) must be provided to 
Auris or its designee.  
The following criteria must also be adhered to by the Investigator in the case of serious 
adverse events: 
• 
The Adverse Event CRF must be signed by the Investigator or Co-Investigator. 
• 
It is the responsibility of the Investigator to inform their IRB of serious adverse events 
as required by their IRB procedures and in conformance with FDA and local 
regulatory requirements. 

 
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All serious adverse events must be reported by the Investigator (or designee) to the sponsor, 
within 24 hours of learning of the adverse event via CRF. The Auris contact information for 
questions is: 
14.3. Device Failures and Malfunctions 
All reported device observations, malfunctions or failures of the Auris ARES are required to 
be documented in the CRF.  Device failures and malfunctions should also be documented 
in the patient’s medical record. 
NOTE: Device failures or malfunctions are NOT to be reported as adverse events. However, 
if there is an adverse event that results from a device failure or malfunction, that specific 
event would be recorded in the usual way. 
15. Ethical Considerations 
15.1. Study Conduct & the Declaration of Helsinki 
The Study will be performed in accordance with the relevant parts of Title 21 CFR Parts 
812, 50, 54, 56 and ISO 14155-1 / 14155-2.1; the ICH Guidelines for Good Clinical Practices 
(E6), the Declaration of Helsinki, and any regional and/or national regulations. 
15.2. Institutional Review Board/Ethics Committee 
A copy of the protocol, proposed Informed Consent form, other written patient 
information and any proposed advertising material must be submitted to the IRB for 
written approval.  A copy of the written IRB approval of the protocol and Informed 
Consent form must be received by Auris Surgical Robotics, Inc. before recruitment of 
patients into the study and shipment of product. 
The Investigator must submit and, where necessary, obtain approval from the IRB as well 
as the FDA, for all subsequent significant protocol amendments and significant changes 
to the Informed Consent form.  The Investigator should notify the IRB of deviations from 
the protocol or SAEs and UADEs occurring at the site and other SAE/UADE reports 
received from Auris Surgical Robotics, Inc in accordance with local procedures. 
The Investigator will be responsible for obtaining annual IRB approval and renewal 
throughout the duration of the study. Copies of the Investigator’s reports and the IRB 
continuance of approval must be sent to Auris Surgical Robotics, Inc.  

 
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15.3. Informed Consent Form 
A sample Informed Consent form is provided in Section 21 Attachment 2 for the 
Investigator to prepare for use at his/her site. The written Informed Consent documents 
should be prepared in the language(s) of the potential patient population. 
The reviewing IRB and the sponsor must first approve the Informed Consent forms that 
are used. The Informed Consent forms that are used should be in accordance with the 
current guidelines as outlined by the Good Clinical Practices (GCP) guidelines, Declaration 
of Helsinki and the International Conference on Harmonization (ICH).  
Prior to participation in the clinical Study, each patient must give written Informed 
Consent after the context of the study has been fully explained to the patient in language 
that is easily understood by the patient. The patients must also be given the opportunity 
to ask questions and have those questions answered to their satisfaction. 
Written Informed Consent must be recorded appropriately by means of the patient’s, or 
their legal representative’s dated signature. The patient will receive a copy of the 
Informed Consent form. 
15.4. Amending the Protocol 
An Investigator may not make protocol changes without prior approval by Auris Surgical 
Robotics.  All significant protocol changes that may affect the following must be submitted 
and approved by the IRB before initiating the change: 
• validity of the data or information resulting from the completion of the approved 
protocol; 
• relationship of the likely subject risk to benefit relied upon to approve the protocol; 
• scientific soundness of the investigational plan, or; 
• rights, safety, or welfare of the human subjects involved in the investigation. 
Auris will submit a copy of the protocol amendment to the Investigator for his IRB to 
review.  The investigative site must send Auris Surgical Robotics a copy of the IRB approval 
letter for the protocol amendment. 
Auris may make certain administrative changes to the protocol without prior approval of 
the IRB.  The site IRB will be notified of these changes. 
15.5. Emergency Actions 
Auris Surgical Robotics, Inc accepts the right of the Investigator to deviate from the 
protocol in an emergency when necessary to safeguard the life or the physical well-being 
of a study patient. The Investigator must give notice of any emergency deviations and 
justification for the deviation to Auris Surgical Robotics, Inc and the IRB as quickly as 
possible after the episode, in any event no later than 24 hours after the emergency. 
15.6. Protocol Deviations 
A protocol deviation is defined as an event where the Clinical Investigator or site 
personnel did not conduct the study according to the protocol. 

 
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Investigators shall be required to obtain prior approval from Auris management before 
initiating deviations from the protocol, except where necessary to protect the life or 
physical well-being of a subject in an emergency.  Such approval shall be documented in 
writing and maintained in clinical study management and Investigator files.  Prior 
approval is generally not expected in situations where unforeseen circumstances are 
beyond the Investigator’s control, (e.g. subject was not available for scheduled follow-up 
office visit, blood sample lost by laboratory, etc.); however, the event is still considered a 
deviation and will be reported via the appropriate CRF. 
Deviations must be reported to Auris regardless of whether medically justifiable, pre-
approved by Auris or taken to protect the subject in an emergency.  Subject specific 
deviations will be reported on the Protocol Deviation case report form.  Non-subject 
specific deviations, (e.g. unauthorized use of an, AURIS ROBOTIC ENDOSCOPY SYSTEM (ARES) 
device outside the study, unauthorized use of an AURIS ROBOTIC ENDOSCOPY SYSTEM (ARES) 
device by a physician who has not signed an Investigator agreement or not been trained 
in the use of the device, etc.), will be reported to Auris reported via the appropriate CRF.  
Investigators will also adhere to procedures for reporting study deviations to their IRB in 
accordance with their specific IRB reporting policies and procedures. 
Regulations require that Investigators maintain accurate, complete and current records, 
including documents showing the dates of and reasons for each deviation from the 
protocol.  For reporting purposes, Auris classifies study deviations as major and minor: 
Major deviation:  Any deviation from subject inclusion and exclusion criteria, subject 
informed consent procedures or unauthorized device use. 
Minor deviation: Deviation from a protocol requirement such as incomplete/inadequate 
subject testing procedures, follow-ups performed outside specified time windows, etc. 
Minor Deviations that continue to occur at an investigational site may be classified as 
Major Deviations if corrective action is not taken to secure future compliance to the 
protocol. 
15.7. Coverage of Expenses 
The treated subjects will not be reimbursed or compensated for participating in the Study. 
15.8. Confidentiality  
Confidentiality of subjects will be maintained throughout the Study.  A unique 
identification code will be assigned to each subject participating in this Study.  Any data 
that may be published in abstracts, scientific journals, or presented at medical meetings 
will reference a unique subject code and will not reveal the subject’s identity.  The 
Sponsor will make every reasonable effort to protect the confidentiality of the subjects 
participating in the Study. 

 
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16. Study Administration 
Auris Surgical Robotics, Inc. in cooperation with the Investigator will make necessary efforts 
to ensure that this study is conducted in compliance with GCPs and all applicable regulatory 
requirements. 
16.1. Pre-Study Documentation Requirements 
Prior to shipment of product, the following documents must be provided to Auris Surgical 
Robotics, Inc: 
• 
Signed and dated Investigator Agreement 
• 
A copy of the written IRB approval of the protocol  
• 
A copy of the written IRB approval of the Informed Consent Form  
• 
A copy of the curriculum vitae of the Principal Investigator and Co-Principal 
Investigator (if applicable) 
16.2. Source Documentation 
The Principal Investigator must maintain detailed source documents on all Study subjects 
who are enrolled in the Study or who undergo screening.  Potential source documents 
include subject medical records including: hospital charts, clinic charts, Investigator’s 
subject Study files, as well as the results of diagnostic tests (e.g., laboratory tests). 
The following minimum information should be recorded in the subject’s medical records: 
• 
The date the subject entered the Study and the subject number 
• 
The Study protocol number and the name of the Sponsor 
• 
The date that informed consent was obtained 
• 
Evidence that the subject meets Study eligibility requirements (e.g., medical history, 
Study procedures and/or evaluations) 
• 
The dates of all Study related subject visits 
• 
Evidence that required procedures and/or evaluations were completed 
• 
Use of any concurrent medications 
• 
Documentation of specific device used, if any 
• 
Occurrence and status of any Adverse Events 
• 
The date the subject exited the Study, and a notation as to whether the subject 
completed the Study or was discontinued, including the reason for discontinuation. 
16.3. Record Retention 
The Investigator will maintain all essential Study documents and source documentation, 
in original format, that support the data collected on the study patients in compliance 
with the ICH/GCP guidelines. Documents must be retained for at least 2 years after the 
last approval of marketing application or until at least 2 years have elapsed since the 
formal discontinuation of the clinical investigation of the product. These documents will 

 
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be retained for a longer period of time by agreement with Auris Surgical Robotics, Inc or 
in compliance with other regulatory requirements. When these documents no longer 
need to be maintained, it is Auris’s responsibility to inform the Investigator. The 
Investigator will take measures to ensure that these essential documents are not 
accidentally damaged or destroyed. If for any reason the Investigator withdraws 
responsibility for maintaining these essential documents, custody must be transferred to 
an individual who will assume responsibility. Auris Surgical Robotics, Inc must receive 
written notification of this custodial change.  
16.4. Criteria for Terminating Study 
Auris Surgical Robotics, Inc reserves the right to terminate the study but intends only to 
exercise this right for valid scientific or administrative reasons and reasons related to 
protection of patients. Investigators and associated IRB will be notified in writing in the 
event of termination. 
Possible reasons for study termination include: 
• 
The discovery of an unexpected, significant, or unacceptable risk to the patients 
enrolled in the study. 
• 
A decision on the part of Auris Surgical Robotics, Inc to suspend or discontinue 
development of the device. 
16.5. Criteria for Suspending/Terminating a Study Center 
Auris Surgical Robotics, Inc reserves the right to stop the study center at any time after 
the study initiation visit if no patients have been enrolled or if the center has multiple or 
severe protocol violations without justification or fails to follow remedial actions. 
Possible reasons for suspending/terminating a study center include: 
• 
Repeated failure to complete case report forms prior to scheduled monitoring visits. 
• 
Failure to obtain written Informed Consent. 
• 
Failure to report CEC Events/SAE/UADE to Auris Surgical Robotics, Inc. within 24 hours 
of knowledge. 
16.6. Investigator Responsibilities 
• 
Agree to sign and adhere to the Investigator Agreement 
• 
Agree to participate in Investigator meetings as scheduled by Auris Surgical Robotics, 
Inc 
• 
Be willing to provide required assessments for analysis 
• 
Be willing to perform and be capable of performing treatment procedures as outlined 
in this protocol 
• 
Comply with all required elements of this protocol (e.g., perform testing and follow-
up as specified, especially during personnel transitions) and supply material suitable 
for quantitative analysis 

 
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• 
Agree to obtain written Informed Consent before any study specific procedures are 
performed in accordance with GCP 
• 
Complete all CRFs prior to scheduled monitoring visits 
• 
Be willing to change hospital routine if required by protocol (as long as patient safety 
and well-being is not compromised) 
17. Publication Policy 
The existence of this clinical Study is confidential, and it should not be discussed with 
persons outside of the Study.  Additionally, the information in this document and regarding 
this Study contains trade secrets and commercially sensitive information that is confidential 
and may not be disclosed unless such disclosure is required by regional or national law or 
regulations.  Subject to the foregoing, this information may be disclosed only to those 
persons involved in the Study who have a need to know, but all such persons must be 
instructed not to further disseminate this information to others.  These restrictions of 
disclosure will apply equally to all future information provided that is indicated as 
confidential. 
The data generated by this clinical Study are the property of the Sponsor, Auris Surgical 
Robotics, Inc., and should not be disclosed without their prior written permission.  These 
data may be used by the Sponsor now and in the future for presentation or publication at 
Sponsor’s discretion or for submission to governmental regulatory agencies.  The Principal 
Investigators may publish or present the Study results with prior consent of the Sponsor, 
but will not disclose confidential information.  Prior to submission by a Principal Investigator 
for publication or presentation, the Sponsor will be provided with the opportunity to review 
the submission for confidential information and accuracy. 
18. Regulatory Considerations 
18.1. Role of Auris Surgical Robotics 
As the sponsor of this clinical study, Auris has the overall responsibility for the conduct of 
the study, including assurance that the study meets all applicable regulatory requirements 
of the Food and Drug Administration (FDA).  In this study, Auris may have certain direct 
responsibilities and may delegate other responsibilities to Consultants.  Together, both 
Auris and its Consultants will ensure adherence to the sponsor’s general duties.  These 
regulations may include applicable portions of: (21 CFR 812.40), selection of Investigators 
(21 CFR 812.43), monitoring (21 CFR 812.46), supplemental applications (21 CFR 812.35 (a) 
and (b)), maintaining records (21 CFR 812.140 (b)), and submitting reports (21 CFR 812.150 
(b)). 
 
Sponsor may choose to appoint a steering committee for the study; this committee may 
include investigators, other experts not otherwise involved in the trial, and 
representatives of the sponsor. A sponsor may delegate and/or seek advice from trial 
steering committee members about study design, ongoing monitoring of study conduct 

 
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and adjudication of individual adverse events. In addition, the trial steering committee 
members may be asked to participate in the analysis and/or interpretation of data as well 
as to revise manuscript(s) before submission.  
 
18.2. General Duties [21 CFR 812. 40] 
No IDE application to FDA is required for this NSR Study.  The Sponsor and the Investigator 
are responsible for obtaining IRB approval prior to start of the study.  As the sponsor, 
Auris is also required to obtain signed study agreements, to provide the Investigators with 
the information necessary to conduct the study and adequate on-site training to conduct 
the Study, to ensure proper clinical site monitoring, and to provide the required reports 
to the Investigators, and IRBs. 
Auris will be responsible for providing quality data that satisfies publication requirements 
and informing of serious unanticipated adverse events and deviations from the protocol. 
18.3. Monitoring [21 CFR 812. 46] 
Sponsor will conduct investigational site monitoring to ensure that all Investigators are in 
compliance with the protocol and the Investigators’ agreements. The sponsor and/or 
designee will monitor the sites to ensure that the completed Case Report Forms match 
the medical records, and resolve any differences. The sponsor will retain the right to 
remove either the Investigator or the investigational site from the study. 
The sponsor will review significant new information, including unanticipated serious 
adverse events and ensure that such information is provided to the Investigators and to 
all reviewing IRB’s. 
18.4. Supplemental Applications [21 CFR 812. 335 (A) and (B)] 
As appropriate, the sponsor will submit changes in the Investigational Plan to the 
Investigators to obtain IRB re-approval.  No FDA submissions are required. 
18.5. Maintaining Records [21 CFR 812. 140 (B)] 
The sponsor will maintain copies of correspondence, data, shipment of devices, serious 
adverse device effects and other records related to the clinical Study.  The sponsor will 
maintain records related to the signed Investigator Agreements.   
18.6. Submitting Reports [21 CFR 812. 150 (B)] 
No FDA submissions are required for the NSR Study. 
18.7. Site Record Retention Policy [21 CFR 812. 140 (D)] 
The sponsor and clinical sites will maintain all records pertaining to this study for a period 
of two years following: the date on which the investigation is terminated or completed, 
or the date that the records are no longer required for purposes of supporting a pre-

 
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market approval application.  Record retention dates will be provided to all concerned by 
the sponsor. 
18.8. Informed Consent & Institutional Review Board (IRB) [21 CFR Parts 50 & 56] 
All subjects must provide written informed consent in accordance with the local clinical 
site’s IRB.  A copy of the consent form from each center must be forwarded to the Sponsor 
for review and approval prior to submitting it to the IRB.  The site must provide the 
Sponsor with a copy of the clinical site’s IRB approval letter and the informed consent.  
Yearly approvals for the continuation of the Study at each clinical site must also be 
forwarded to the Sponsor. 
All Protected Health Information (PHI) to be collected in the study will be described in the 
informed consent form, and all study data will be managed in accordance with the Privacy 
Law (HIPAA). 
19. Abbreviations and Definitions 
19.1. Abbreviations 
 
ACT 
Activated clotting time 
AE 
Adverse Event 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CV 
Curriculum Vitae 
FDA 
Food and Drug Administration 
Hgb 
Hemoglobin 
Hct 
Hematocrit 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
MDR 
Medical Device Reporting 
SAE 
Serious Adverse Event 
UADE 
Unanticipated Adverse Device Event 
19.2. Definitions 
ADVERSE EVENT SEVERITY RATING 
Mild: 
Awareness of signs or symptoms, but easily tolerated; are of minor 
irritant type; causing no loss of time from normal activities; symptoms 

 
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would not require medication or a medical evaluation; signs or symptoms 
are transient. 
Moderate: 
Interferes with the subject’s usual activity and/or requires symptomatic 
treatment. 
Severe: 
Symptom(s) causing severe discomfort and significant impact of the 
subject’s usual activity and requires treatment. 
 
APPROVAL (IN RELATION TO INSTITUTIONAL REVIEW BOARDS (IRBs) 
The affirmative decision of the IRB that the clinical investigation has been reviewed and 
may be conducted at the institutional site within the constraints set forth by the IRB, the 
institution, Good Clinical Practice (GCP), and the applicable regulatory requirements. 
CO-INVESTIGATOR / SUB-INVESTIGATOR 
Any individual member of the clinical investigation team designated and supervised by 
the Investigator at an investigational site who performs critical investigation-related 
procedures and/or makes important investigation-related observations.  See also 
Investigator.  
CONFIDENTIALITY  
Prevention of disclosure, to other than authorized individuals, of a Sponsor's proprietary 
information or of a subject's identity / Protected Health Information (PHI) in compliance 
with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
DEVICE FAILURE / MALFUNCTION 
The device does not perform in accordance with the IFU. 
CASE REPORT FORM (CRF) 
A document designed to record all of the protocol-required information to be reported 
to the Sponsor on each subject. 
INFORMED CONSENT 
A process by which a subject voluntarily confirms in writing his or her willingness to 
participate in a particular investigation, after having been informed of all aspects of the 
investigation that are relevant to the subject's decision to participate.  Informed consent 
is documented by means of a written, signed, and dated Informed Consent form.  
INVESTIGATIONAL SITE 
The location(s) where investigation-related activities are actually conducted.  
INVESTIGATOR 
The person responsible for the conduct of the clinical investigation at an investigational 
site.  If an investigation is conducted by a team of individuals at an investigational site, 

 
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the Investigator is the responsible leader of the team and may be called the Principal 
Investigator.  See also Co-Investigator.  
 
 
SERIOUS ADVERSE EVENT (SAE)  
Any untoward medical occurrence that results in death, is life threatening, requires 
subject hospitalization or prolongation of existing hospitalization, or results in persistent 
or significant disability/incapacity.  
SUB-INVESTIGATOR / CO-INVESTIGATOR 
Any individual member of the clinical investigation team designated and supervised by 
the Investigator at an investigational site who performs critical investigation-related 
procedures and/or makes important investigation-related observations.  See also 
Investigator.  
SUBJECT 
An individual who participates in a clinical investigation. 
UNANTICIPATED ADVERSE DEVICE EFFECTS (UADE) 
Any serious adverse effect on health or safety or any life-threatening problem or death 
caused by, or associated with the study device, if that effect, problem or death was not 
previously identified in nature, severity, or degree of incidence in the Investigational Plan 
or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects. 
19.3. Bibliography 
 
1 Jemal A, Siegel R, Xu J, Ward E. Cancer Statistics 2010. Ca Cancer, J Clin 2010;60:277–300.  
 
2 Aberle R, Adams AM, Berg CD, et al. National lung screening trial research team. Reduced lung-cancer mortality 
with low-dose computed tomographic screening. N Engl J Med 2011;365:395–409.  
 
3 Gilbert C, Akulian J, Ortiz R, Lee H, Yarmus L. Novel bronchoscopic strategies  
for the diagnosis of peripheral lung lesions: present techniques and future  
directions. Respirology. 2014 Jul;19(5):636-44.   

 
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20. Attachment 1: Investigator Responsibilities, Records and Reports 
20.1. Investigator Responsibilities 
The investigator is responsible for ensuring that this Study is conducted according to this 
protocol and that signed Informed Consent is obtained from each subject prior to their 
inclusion in this Study. 
It is the investigator’s responsibility to ensure that all staff assisting with this Study have 
the appropriate qualifications and are fully instructed on the Study procedures and RPN 
subject confidentiality, as specified in the Investigator Agreement with the Sponsor. 
The investigator is responsible for ensuring that the conduct of the Study conforms to the 
IRB requirements and provides all necessary communication with the IRB including, but 
not limited to, annual Study reports and required adverse event notifications. 
20.2. Investigator Records 
Case REPORT FORMS 
The standardized Case Report Forms (CRFs) will be used to collect complete and accurate 
records of the clinical data from the Study according to the Good Clinical Practice (GCP) 
requirements.  The investigator is responsible for collecting and accurately recording the 
data generated for this Study. 
SCREENING LOG 
Investigators will maintain a screening log that will record the date of informed consent, 
the date of screening, the enrollment status (enrolled/excluded) and the reason for 
exclusion for all screen failures. 
20.3. Investigator Reports 
FINAL STUDY REPORT 
A summary of the final report will be prepared and provided to each Principal Investigator 
for submission to their respective IRB after completion of the Study. 
SERIOUS ADVERSE EVENTS (SAES) 
The investigators will report by CRF any SAEs including serious, and/or potentially device- 
or procedure-related adverse events as soon as possible, within 24 hours of the 
investigator becoming aware of the event, to the Sponsor and to the IRB as per the 
committee’s reporting requirements.  The Serious Adverse Event CRF is to be completed 
and submitted to the Sponsor as initial notification.  
DEVICE MALFUNCTIONS 

 
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The investigators will report by telephone, email or fax any Device Malfunctions as soon 
as possible, within 24 hours of the investigator becoming aware of the event, to the 
Sponsor. 
WITHDRAWAL OF APPROVAL 
If an IRB withdraws the approval to conduct this Study for any reason, the investigator 
will notify the Sponsor as soon as possible, but in no event later than five working days 
after the withdrawal of the approval. 
 

 
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21. Attachment 2: Sample Informed Consent Form 
 
 

 
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22. Attachment 3: Instructions For Use (IFU) 
  
 
 

 
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23. Attachment 4: Declaration of Helsinki 
 
WORLD MEDICAL ASSOCIATION DECLARATION OF HELSINKI 
 
 
Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA 
General Assembly Helsinki, Finland, June 1964 and amended by the: 
 
29th WMA General Assembly, Tokyo, Japan, October 1975 
35th WMA General Assembly, Venice, Italy, October 1983 
41st WMA General Assembly, Hong Kong, September 1989 
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996 
and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 
A. 
INTRODUCTION 
1. 
The World Medical Association has developed the Declaration of Helsinki as a statement of 
ethical principles to provide guidance to physicians and other participants in medical 
research involving human subjects. Medical research involving human subjects includes 
research on identifiable human material or identifiable data. 
2. 
It is the duty of the physician to promote and safeguard the health of the people. The 
physician's knowledge and conscience are dedicated to the fulfillment of this duty. 
3. 
The Declaration of Geneva of the World Medical Association binds the physician with the 
words, "The health of my patient will be my first consideration," and the International Code 
of Medical Ethics declares that, "A physician shall act only in the patient's interest when 
providing medical care which might have the effect of weakening the physical and mental 
condition of the patient." 
4. 
Medical progress is based on research which ultimately must rest in part on 
experimentation involving human subjects. 
5. 
In medical research on human subjects, considerations related to the well-being of the 
human subject should take precedence over the interests of science and society. 
6. 
The primary purpose of medical research involving human subjects is to improve 
prophylactic, diagnostic and therapeutic procedures and the understanding of the etiology 
and pathogenesis of disease. Even the best proven prophylactic, diagnostic, and 
therapeutic methods must continuously be challenged through research for their 
effectiveness, efficiency, accessibility and quality. 
7. 
In current medical practice and in medical research, most prophylactic, diagnostic and 
therapeutic procedures involve risks and burdens. 

 
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8. 
Medical research is subject to ethical standards that promote RPN for all human beings and 
protect their health and rights. Some research populations are vulnerable and need special 
protection. The particular needs of the economically and medically disadvantaged must be 
recognized. Special attention is also required for those who cannot give or refuse consent 
for themselves, for those who may be subject to giving consent under duress, for those 
who will not benefit personally from the research and for those for whom the research is 
combined with care. 
9. 
Research Investigators should be aware of the ethical, legal and regulatory requirements 
for research on human subjects in their own countries as well as applicable international 
requirements. No national ethical, legal or regulatory requirement should be allowed to 
reduce or eliminate any of the protections for human subjects set forth in this Declaration. 
B. 
BASIC PRINCIPLES FOR ALL MEDICAL RESEARCH 
10. 
It is the duty of the physician in medical research to protect the life, health, privacy, and 
dignity of the human subject. 
11. 
Medical research involving human subjects must conform to generally accepted scientific 
principles, be based on a thorough knowledge of the scientific literature, other relevant 
sources of information, and on adequate laboratory and, where appropriate, animal 
experimentation. 
12. 
Appropriate caution must be exercised in the conduct of research which may affect the 
environment, and the welfare of animals used for research must be RPNed. 
13. 
The design and performance of each experimental procedure involving human subjects 
should be clearly formulated in an experimental protocol. This protocol should be 
submitted for consideration, comment, guidance, and where appropriate, approval to a 
specially appointed ethical review committee, which must be independent of the 
investigator, the sponsor or any other kind of undue influence. This independent 
committee should be in conformity with the laws and regulations of the country in which 
the research experiment is performed. The committee has the right to monitor ongoing 
Studies. The researcher has the obligation to provide monitoring information to the 
committee, especially any serious adverse events. The researcher should also submit to the 
committee, for review, information regarding funding, sponsors, institutional affiliations, 
other potential conflicts of interest and incentives for subjects. 
14. 
The research protocol should always contain a statement of the ethical considerations 
involved and should indicate that there is compliance with the principles enunciated in this 
Declaration. 
15. 
Medical research involving human subjects should be conducted only by scientifically 
qualified persons and under the supervision of a clinically competent medical person. The 
responsibility for the human subject must always rest with a medically qualified person and 
never rest on the subject of the research, even though the subject has given consent. 
16. 
Every medical research project involving human subjects should be preceded by careful 
assessment of predictable risks and burdens in comparison with foreseeable benefits to 

 
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the subject or to others. This does not preclude the participation of healthy volunteers in 
medical research. The design of all studies should be publicly available. 
17. 
Physicians should abstain from engaging in research projects involving human subjects 
unless they are confident that the risks involved have been adequately assessed and can 
be satisfactorily managed. Physicians should cease any investigation if the risks are found 
to outweigh the potential benefits or if there is conclusive proof of positive and beneficial 
results. 
18. 
Medical research involving human subjects should only be conducted if the importance of 
the objective outweighs the inherent risks and burdens to the subject. This is especially 
important when the human subjects are healthy volunteers. 
19. 
Medical research is only justified if there is a reasonable likelihood that the populations in 
which the research is carried out stand to benefit from the results of the research. 
20. 
The subjects must be volunteers and informed participants in the research project. 
21. 
The right of research subjects to safeguard their integrity must always be RPNed. Every 
precaution should be taken to RPN the privacy of the subject, the confidentiality of the 
patient's information and to minimize the impact of the study on the subject's physical and 
mental integrity and on the personality of the subject. 
22. 
In any research on human beings, each potential subject must be adequately informed of 
the aims, methods, sources of funding, any possible conflicts of interest, institutional 
affiliations of the researcher, the anticipated benefits and potential risks of the study and 
the discomfort it may entail. The subject should be informed of the right to abstain from 
participation in the study or to withdraw consent to participate at any time without 
reprisal. After ensuring that the subject has understood the information, the physician 
should then obtain the subject's freely-given informed consent, preferably in writing. If the 
consent cannot be obtained in writing, the non-written consent must be formally 
documented and witnessed. 
23. 
When obtaining informed consent for the research project the physician should be 
particularly cautious if the subject is in a dependent relationship with the physician or may 
consent under duress. In that case the informed consent should be obtained by a well-
informed physician who is not engaged in the investigation and who is completely 
independent of this relationship. 
24. 
For a research subject who is legally incompetent, physically or mentally incapable of giving 
consent or is a legally incompetent minor, the investigator must obtain informed consent 
from the legally authorized representative in accordance with applicable law. These groups 
should not be included in research unless the research is necessary to promote the health 
of the population represented and this research cannot instead be performed on legally 
competent persons. 
25. 
When a subject deemed legally incompetent, such as a minor child, is able to give assent 
to decisions about participation in research, the investigator must obtain that assent in 
addition to the consent of the legally authorized representative. 

 
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26. 
Research on individuals from whom it is not possible to obtain consent, including proxy or 
advance consent, should be done only if the physical/mental condition that prevents 
obtaining informed consent is a necessary characteristic of the research population. The 
specific reasons for involving research subjects with a condition that renders them unable 
to give informed consent should be stated in the experimental protocol for consideration 
and approval of the review committee. The protocol should state that consent to remain 
in the research should be obtained as soon as possible from the individual or a legally 
authorized surrogate. 
27. 
Both authors and publishers have ethical obligations. In publication of the results of 
research, the investigators are obliged to preserve the accuracy of the results. Negative as 
well as positive results should be published or otherwise publicly available. Sources of 
funding, institutional affiliations and any possible conflicts of interest should be declared in 
the publication. Reports of experimentation not in accordance with the principles laid down 
in this Declaration should not be accepted for publication. 
 
C. 
ADDITIONAL PRINCIPLES FOR MEDICAL RESEARCH COMBINED WITH MEDICAL CARE 
1. 
The physician may combine medical research with medical care, only to the extent that the 
research is justified by its potential prophylactic, diagnostic or therapeutic value. When 
medical research is combined with medical care, additional standards apply to protect the 
patients who are research subjects. 
2. 
The benefits, risks, burdens and effectiveness of a new method should be tested against 
those of the best current prophylactic, diagnostic, and therapeutic methods. This does not 
exclude the use of placebo, or no treatment, in studies where no proven prophylactic, 
diagnostic or therapeutic method exists. 
3. 
At the conclusion of the study, every patient entered into the study should be assured of 
access to the best proven prophylactic, diagnostic and therapeutic methods identified by 
the study. 
4. 
The physician should fully inform the patient which aspects of the care are related to the 
research. The refusal of a patient to participate in a study must never interfere with the 
patient-physician relationship. 
5. 
In the treatment of a patient, where proven prophylactic, diagnostic and therapeutic 
methods do not exist or have been ineffective, the physician, with informed consent from 
the patient, must be free to use unproven or new prophylactic, diagnostic and therapeutic 
measures, if in the physician's judgement it offers hope of saving life, re-establishing health 
or alleviating suffering. Where possible, these measures should be made the object of 
research, designed to evaluate their safety and efficacy. In all cases, new information 
should be recorded and, where appropriate, published. The other relevant guidelines of 
this Declaration should be followed.