Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter Pilot and Feasibility Study
Phase: NA
Conditions: Lung; Node
Sponsor: Auris Health, Inc.

 
Auris Health, Inc.   
 
 
 
Protocol No: 18-BR-0001             CONFIDENTIAL            August 20, 2018 
                     Page 1 of 44 
 
1. Cover Page 
 
STUDY TITLE: 
Robotic Bronchoscopy for Peripheral Pulmonary 
Lesions: A Multicenter Pilot and Feasibility Study 
 
Study acronym:      The BENEFIT Study 
 
PROTOCOL 
NUMBER: 
 
18-BR-0001 
VERSION: 
2 
DATE: 
August 20, 2018 
 
 
 
 
Revision History 
 
Version 
Description of Change 
1 
Initial release 
1a 
Administrative change to correct typos and clarify timing of chest X-ray 
following the procedure as requested by MUSC IRB (only MUSC) 
               2 
Administrative change to clarify and resolve inconsistencies in the 
protocol and to conduct the study according to the unified protocol at all 
centers 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Clinical Investigation Plan (CIP) and Protocol 
Identification of Responsibility Page 
 
Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter 
Pilot and Feasibility Study  
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 Health, Inc. 
125 Shoreline Dr 
Redwood City, CA 94065 
Sponsor Contact: 
Scott Rehage 
Email: 
scott.rehage@aurishealth.com 
Principal Investigators / 
Study Centers: 
Listed in Appendix III 
 
Date of Issue: 
 August 20, 2018 Version 2 
 
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 No: 18-BR-0001
CONFIDENTIAL 
 August 20, 2018 
 Page 3 of 44 
Robotic Bronchoscopy for Peripheral Pulmonary Lesions: 
A Multicenter Pilot and Feasibility Study 
Approval Page 
STUDY TITLE: 
Robotic Bronchoscopy for Peripheral Pulmonary 
Lesions: A Multicenter Pilot and Feasibility Study 
PROTOCOL 
NUMBER: 
18-BR-0001
VERSION 
NUMBER: 
2 
DATE: 
August 20, 2018 
We, the undersigned, have read and approve the protocol specified above and agree on its content. 
Josh DeFonzo 
Date: 
Emir Deljkich 
Date: 
Joy Sacmar 
Date: 

Auris Health, Inc.
Robotic Bronchoscopy for Peripheral Pulmonary Lesions: 
A Multicenter Pilot and Feasibility Study 
Approval Page 
STUDY TITLE: 
PROTOCOL 
NUMBER: 
VERSION 
NUMBER: 
DATE: 
Robotic Bronchoscopy for Peripheral Pulmonary 
Lesions: A Multicenter Pilot and Feasibility Study 
18-BR-0001
2 
August 20, 2018 
We, the undersigned, have read and approve the protocol specified above and agree on its content. 
Joy Sacmar aow+ 
Protocol No: 18-BR-0001 
Page 3 of 44 
CONFIDENTIAL 
Z I 
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Date: 
Date: 
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Date: 
August 20, 2018 

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Protocol No: 18-BR-0001
CONFIDENTIAL 
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AURIS study – Investigator’s Signature Page 
STUDY TITLE: 
Robotic Bronchoscopy for Peripheral Pulmonary 
Lesions: A Multicenter Pilot and Feasibility Study 
STUDY CENTER: 
<Insert Study Center, Location> 
I, the undersigned, have read and understand the protocol specified above and agree on its 
content. I agree to perform and conduct the study as described in the protocol. In addition, when 
applicable, I agree to enlist sub-investigators who also agree to perform and conduct the study as 
described in the protocol. 
___________________________________________________________________ 
SITE PI – Print Name 
___________________________________________________________________ 
SITE PI – Signature 
_______________________ 
DATE 

 
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1.1 Table of Contents 
 
1. 
Cover Page ........................................................................................................................... 1 
Identification of Responsibility Page .......................................................................................... 2 
Approval Page ............................................................................................................................. 3 
AURIS study – Investigator’s Signature Page ............................................................................ 4 
1.1 
Table of Contents .......................................................................................................... 5 
1.2 
Amendment Change History ........................................................................................ 7 
1.3 
Synopsis of Trial ........................................................................................................... 8 
2. 
Introduction ....................................................................................................................... 10 
2.1 
Background ................................................................................................................. 10 
Specific Risk and Benefits .................................................................................................... 11 
Risks of procedures ......................................................................................................... 11 
Research only risks .......................................................................................................... 12 
Benefits ............................................................................................................................. 13 
2.2 
Purpose ....................................................................................................................... 13 
3. 
Trial Objectives ................................................................................................................. 13 
4. 
Investigational Plan ........................................................................................................... 13 
4.1 
Trial Endpoints ........................................................................................................... 13 
4.2 
Trial Design ................................................................................................................ 14 
Follow-up .............................................................................................................................. 20 
Study Exit .............................................................................................................................. 20 
Criteria for Terminating Study .............................................................................................. 20 
Criteria for Suspending/Terminating a Study Center............................................................ 20 
4.3 
Investigational product ............................................................................................... 21 
Bronchoscope ........................................................................................................................ 21 
Auris Cart .............................................................................................................................. 21 
Auris Tower .......................................................................................................................... 22 
Auris Cart External Components .......................................................................................... 24 
Fluidics Control ................................................................................................................ 24 
Electro-Magnetic Field generator ..................................................................................... 24 
Reference Electro-Magnetic sensors ................................................................................. 24 
Device Labeling ................................................................................................................. 24 
Device Distribution .......................................................................................................... 24 
Device Accountability...................................................................................................... 24 
Return of Materials Upon Study Termination ............................................................. 24 
5. 
Criteria for subject withdrawal .......................................................................................... 24 
5.1 
Subject inclusion criteria ............................................................................................ 25 
5.2 
Subject exclusion criteria ............................................................................................ 25 
6. 
Treatment of subjects......................................................................................................... 26 
7. 
Assessment of efficacy ...................................................................................................... 26 

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8.
Assessment of safety ......................................................................................................... 27 
Primary Safety Endpoint ....................................................................................................... 27 
Secondary Safety Endpoint ................................................................................................... 27 
Adverse Events ......................................................................................................................... 28 
General Reporting Requirements (Serious & Non-Serious Adverse Events)............ 30 
Device Failures and Malfunctions ........................................................................................ 30 
9.
Statistical Methods ............................................................................................................ 30 
10. Access to source documentation ....................................................................................... 31 
Record Retention ................................................................................................................... 31 
11. Quality control and quality assurance ............................................................................... 32 
Site Training .......................................................................................................................... 32 
Physician Training ................................................................................................................ 32 
Audits and Inspections .......................................................................................................... 32 
Amending the Protocol ......................................................................................................... 32 
Emergency Actions ............................................................................................................... 33 
Protocol Deviations ............................................................................................................... 33 
Coverage of Expenses ........................................................................................................... 33 
Confidentiality ...................................................................................................................... 34 
12. Ethics ................................................................................................................................. 34 
Study Conduct & the Declaration of Helsinki ...................................................................... 34 
Institutional Review Board/Ethics Committee...................................................................... 34 
Informed Consent Form ........................................................................................................ 34 
Investigator Responsibilities ................................................................................................. 35 
13. Data Handling and recordkeeping ..................................................................................... 35 
14. Monitoring ......................................................................................................................... 38 
15. Compensation, Insurance and Indemnity .......................................................................... 39 
16. Publication policy .............................................................................................................. 39 
17. Appendices ........................................................................................................................ 40 
17.1 Appendix I .................................................................................................................. 40 
17.2 Appendix II ................................................................................................................. 41 
Regulatory Considerations ........................................................................................................ 41 
Role of Auris Health ............................................................................................................. 41 
Pre-Study Documentation Requirements .............................................................................. 41 
General Duties [21 CFR 812. 40] ......................................................................................... 41 
Monitoring [21 CFR 812. 46] ............................................................................................... 42 
Supplemental Applications [21 CFR 812. 335 (A) and (B)] ................................................ 42 
Maintaining Records [21 CFR 812. 140 (B)] ....................................................................... 42 
Submitting Reports [21 CFR 812. 150 (B)] .......................................................................... 42 
Site Record Retention Policy [21 CFR 812. 140 (D)] .......................................................... 42 
Informed Consent & Institutional Review Board/Ethic Committee [21 CFR Parts 50 & 56]42 
17.3 Appendix III ................................................................................................................ 43 

 
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17.4 Appendix IV ............................................................................................................... 44 
 
1.2 Amendment Change History 
 
This is version 2 of the protocol. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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1.3 Synopsis of Trial 
 
Robotic Bronchoscopy for Peripheral Pulmonary Lesions: A Multicenter 
Pilot and Feasibility Study 
 
Primary Objective 
The objective of this study is to evaluate the feasibility of performing robotic navigation of 
peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions. 
Test Device 
The Monarch Endoscopy Platform 
Control Device 
None 
Indication 
for Use 
510K #: 173760 
The Monarch Endoscopy Platform is FDA cleared medical device (510K #: 173760) 
intended to provide bronchoscopic visualization of and access to patient airways for 
diagnostic and therapeutic procedures. The system is intended to be used by qualified 
physicians only. 
Hypotheses 
No formal statistical hypotheses are defined.  It is believed that the Monarch platform will 
be capable of enhancing access to peripheral lung lesions. 
Study Design 
A multi-center, prospective, single arm pilot and feasibility study to evaluate the use of a 
robotic endoscopic system to access and biopsy peripheral pulmonary lesions.  The 
Monarch Endoscopy Platform will be used in conjunction with a navigational 
bronchoscopy with biopsy.  
Number of Patients 
The study will enroll up to 55 patients. It is expected that each center will enroll up to 11 
study patients, of which the first patient may be considered roll-in patient and analyzed 
separately.  
Sites 
Investigational sites are listed in the Appendix III. 
Duration of Study 
For the purpose of the study, each enrolled subject will be followed up to 84-hours post 
procedure (a follow-up phone call will be made 24-84 hr post procedure).  The enrollment 
will take up to 45 calendar days per center. The total duration of the study is expected to be 
up to 5 months. 
Primary 
Effectiveness 
Endpoint 
The primary effectiveness endpoint is the successful navigation to targeted peripheral 
pulmonary lesions sized 1-5cm as confirmed using radial probe endobronchial ultrasound 
(R-EBUS).  

 
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Secondary 
Effectiveness 
Endpoints 
The following will be considered secondary endpoints: 
• 
Time to R-EBUS confirmation (lesion localization), time to the tissue acquisition 
confirmation, Total procedure time (from introduction to removal of the 
bronchoscope) and procedure interruptions 
• 
Radiographic and procedural factors that influence the ability to successfully 
navigate to peripheral lesions including size and location of peripheral lesions 
• 
Diagnostic yield 
• 
Conversion to conventional bronchoscopic procedure 
 
Primary Safety 
Endpoint 
Device or procedure related adverse events (AEs). 
Secondary Safety 
Endpoint 
Complications unrelated to device. 
Follow-Up Schedule 
Each enrolled subject will have one follow-up visit (phone call). The phone call will be 
made between 24-84 hours post-procedure. This window is established to accommodate 
patients undergoing the bronchoscopy procedure on Fridays. 
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 1-5cm in size identified 
on thin slice CT scan within 14 days of the intended bronchoscopy 
5. Lack bleeding disorders 
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. Patients with a subsolid nodule and/or ground-glass opacity lesions on pre-procedure 
chest CT 
3. Patients with endobronchial involvement seen on chest CT 
4. Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist 
prior to procedure, and  
5. Participation in any other investigational clinical trial (device or medication) 30 days 
before and throughout the duration of the study; 
6. Uncontrolled or irreversible coagulopathy; 
7. Female subjects who are pregnant or nursing or those of child-bearing potential 
refusing a pregnancy test; 
8. Have significant mediastinal lymphadenopathy on chest CT scan and/or PET CT 
abnormalities suggestive of advanced stage lung cancer with mediastinal lymph node 
involvement  
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. 
Study Sponsorship 
Sponsor 
Auris Health, Inc 
150 Shoreline Dr 
Redwood City, CA 94065 
 

 
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2. Introduction 
Successful biopsy of peripheral pulmonary lesions remains a challenge due to a number 
of factors, one of which may be the ability to gain access to peripheral lesions due to the 
size and maneuverability of conventional bronchoscopes.  In this study, we will evaluate 
the feasibility of a new technique using a robotic endoscope with navigational platform to 
both access and biopsy peripheral pulmonary lesions.   
 
2.1 Background 
Peripheral bronchoscopy is often performed to biopsy peripheral pulmonary lesions 
(PPL’s) for diagnostic purposes.  With the results of the National Lung Cancer Screening 
Trial demonstrating a 20% reduction in lung cancer related death, widespread adoption of 
lung cancer screening programs is expected to result in the detection of significantly 
increased numbers of pulmonary nodules1.  While the majority of these nodules may 
simply require surveillance imaging, many will require biopsy.   
 
Conventional bronchoscopic approaches to peripheral pulmonary lesions is typically 
performed using flexible bronchoscopes with outer diameters of 4 or 6 mm.  The 
bronchoscope is inserted into the tracheobronchial tree and then is maneuvered into 
segmental and subsegmental bronchi by the bronchoscopist.  Rotation and flexion of the 
bronchoscope is performed by the bronchoscopist who is responsible for “driving” the 
bronchoscope into peripheral airways. 
 
Current limitations to using this approach include challenges advancing the bronchoscope 
into peripheral airways due to size limitations of conventional bronchoscopes as 
subsegmental bronchi become progressively smaller as they extend peripherally.  In 
addition to this, subsegmental bronchi often branch at varying angles which often cannot 
be negotiated using conventional bronchoscopes.  These factors may limit the 
bronchoscopist’s ability to advance the bronchoscope into close proximity to peripheral 
pulmonary lesions when attempting biopsy, and this may negatively affect the diagnostic 
yield of the procedure. 
 
Despite technological advancements in guided bronchoscopy such as electromagnetic 
navigation bronchoscopy and radial probe endobronchial ultrasound, the diagnostic yield 
of bronchoscopic approaches for peripheral lesions, particularly those smaller than 2cm, 
remains suboptimal, at less than 60%.2,3,4 
 
Robotic surgery has been performed across many platforms including urologic, 
gynecologic and thoracic surgery, and offers potential advantages of improved dexterity 
and visualization while maintaining minimally invasive approaches5.  Early experience 
using a robotic endoscopic system within human cadaveric lungs demonstrated increased 
reach into the lung periphery using the robotic platform compared with a similarly sized 
bronchoscope6.  Presently, very little data exists regarding the use of a robotic endoscopic 
system in live human subjects with peripheral lesions in need of biopsy. 
 

 
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The Monarch platform is a “robotic” assisted or electromechanical, software driven 
endoscopy system designed to be used by qualified physicians to provide bronchoscopic 
visualization of and access to patient airways for diagnostic and therapeutic procedures. 
The system is intended to be used by qualified physicians only.  FDA has cleared the 
Monarch platform under the 510(k)-clearance process (510K #: 173760).   
The Monarch system has been extensively tested in porcine and cadaver studies.  The 
system has been also tested in a clinical feasibility study to obtain lung biopsy specimens.  
Herein, we propose a multi-center, post-market, clinical trial to evaluate the feasibility of 
a new technique using a robotic endoscope with navigational platform to both access and 
biopsy peripheral pulmonary lesions.   
Specific Risk and Benefits 
Risks of procedures 
 
With any bronchoscopic procedure, there is the possibility of the following risks: 
collapsed lung, pneumothorax, bronchoscopic airway puncture, breathing difficulty, 
vocal cord spasm, vomiting, dizziness, bronchial spasm, infection, low blood oxygen, 
feeling of heaviness in chest, heart attack and bleeding from biopsied site. The 
occurrence of these risks is extremely low.  The measures to mitigate the risks are the 
same as for all bronchoscopy. To minimize the chance of bleeding, all patients will be 
questioned about tendency to bleed prior to bronchoscopy as per standard care. 
Anticoagulation with antiplatelet agents will be held according to guideline 
recommendations for that drug. If bleeding occurs, patients will be treated with direct 
pressure, local instillation of epinephrine or electrocautery. Vocal cord spasm will be 
prevented through the use of lidocaine on the vocal cords. Patients with lung disease may 
receive bronchodilators prior to bronchoscopy at the discretion of the performing 
bronchoscopist. There is no way to reduce the minimal risk of infection due to 
bronchoscopy since the scope must go through the naso or oropharynx. Patients are given 
supplemental oxygen and their oxygen level is continuously monitored using pulse 
oximetry. Patients ECG, heart rate, blood pressure, and blood oxygen are continuously 
monitored by a nurse, respiratory therapist and physician during the procedure. If there is 
any sign of a worsening in status, such as elevated heart rate, low oxygen, or ECG 
changes, the procedure will be aborted. 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. 
 
The additional risks from bronchoscopy are related to anesthesia and the very act of  
intubation and passing a bronchoscope into the airway.  To mitigate risks of 
bronchoscopy all patients will be monitored according to local guidelines for the type of 
anesthesia technique used according to standard of care. In addition, oxygen saturation 
(using pulse oximetry) respiratory rate, blood pressure, ECG, and heart rate will be 

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continuously monitored.  Patients will not be released until they are fully awake and 
medically stable. 
Anesthesia Risk 
Typically, patients will be under general anesthesia during the procedure. This means that 
patients won’t feel anything during intubation. Healthy people usually don’t have any 
problems with general anesthesia, but there’s a small risk of long-term complications. 
These risks largely depend on patients’ general health and the type of procedure you’re 
undergoing. 
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 general or 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. 
Intubation Risk 
With any intubation, there are some risks related to intubation, such as: injury to teeth or 
dental work, injury to the throat or trachea, a buildup of too much fluid in organs of 
tissues, bleeding, lung injury of complications and aspiration (stomach contents and acids 
that end up in the lung). Anesthesiologist or trained personnel will evaluate patients 
before the procedure to help decrease the risk of these complications from occurring. 
You’ll also be monitored carefully throughout the procedure. 
Risk Mitigation 
Risks during study participation will be minimized by the following:  
The study protocol was developed with investigators that is well-known in the area of 
interventional pulmonology.  The sites were chosen because of proven expertise in the field 
of interventional pulmonology.  All Investigators performing the procedure using the 
Monarch Endoscopy Platform 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 the Platform in humans.   Pre-clinical, in vitro and in vivo testing 
has been performed in order to optimize the device safety and function. 
Research only risks 
Every effort will be made to protect the privacy of the research subjects.  All information 
and data related to this study will be maintained in secured, protected space, and access 
will be restricted to study personnel only.  In addition to this, additional procedure time 

 
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may be encountered due to the robotic assisted bronchoscopy procedure, particularly in 
cases where salvage procedures are performed. 
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. 
 
2.2   Purpose 
The purpose of the trial is to evaluate the feasibility and safety of using the Monarch 
Endoscopy Platform to biopsy peripheral pulmonary lesions 1-5cm in size in eligible 
patients. 
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 current versions of the ICH Guidelines 
for Good Clinical Practices, the Declaration of Helsinki, and any regional and/or national 
regulation. 
 
3. Trial Objectives 
Despite technical advancements in guided bronchoscopy, the diagnostic yield for 
peripheral pulmonary lesions remains suboptimal.  One potential explanation for the 
suboptimal yield may be the inability to place the endoscope within close proximity of 
the targeted lesion.  The Monarch Endoscopy Platform has demonstrated the ability to 
reach further into the periphery than a similarly sized conventional thin bronchoscope in 
human cadaveric lungs.  The objective of this study is to evaluate the feasibility of 
performing robotic navigation of peripheral airways in live human subjects for the 
purpose of biopsying peripheral lung lesions. 
 
4. Investigational Plan 
 
4.1 Trial Endpoints 
 
Primary Effectiveness Endpoint 
The primary effectiveness endpoint is the successful navigation to targeted peripheral 
pulmonary lesions sized 1-5cm as confirmed using radial probe endobronchial 
ultrasound. 
Secondary Effectiveness Endpoint 
The following will be considered secondary endpoints: 

 
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o Time to R-EBUS confirmation (lesion localization) 
o Time to the tissue acquisition confirmation 
o Total procedure time (from introduction to removal of the bronchoscope) and 
procedure interruptions 
o Radiographic and procedural factors that influence the ability to successfully 
navigate to peripheral lesions including size and location of peripheral lesions 
o Diagnostic yield 
o Conversion to conventional bronchoscopic procedure 
 
Primary Safety Endpoint 
Device or procedure related adverse events. 
 
Secondary Safety Endpoint 
Complications unrelated to device. 
 
4.2 Trial Design  
This is a prospective, multicenter, open-label pilot and feasibility study to evaluate the 
use of the Monarch Endoscopy Platform to access and biopsy peripheral pulmonary 
lesions. It is expected that up to 5 centers will participate in the trial. Subjects 18 years or 
older presenting with peripheral pulmonary lesions determined to require a non-surgical 
biopsy as per standard medical care and meet study inclusion and exclusion criteria will 
be invited to participate.    Each site principle investigator will determine eligibility and 
will explain the study to qualified subjects prior to obtaining consent. The subject will 
also be given an opportunity to review and sign documentation of HIPAA compliance 
and authorization according to establish practice of the institutions. All subjects are 
required to meet the inclusion/exclusion criteria defined in the sections 5.1 and 5.2 in 
order to be considered eligible for participation in this Study. The study flowchart is 
shown in the Figure 1. 
 
 
 
 
 
 
 
 
 
 
 

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Figure 1.  Schematic of Study Design. 
Investigational Sites 
The Investigational sites are listed in Appendix III. 
Sample size 
The study will enroll up to 55 patients. It is expected that each center will enroll up to 11 
study patients, of which the first patient may be considered roll-in patient and analyzed 
separately. The enrollment will take up to 45 calendar days per center. The total duration 
of the study is expected to be up to 5 months. In case of slower than planned enrollment 
at individual trial sites, other sites may be permitted to enroll more patients. 

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Procedures 
1. Prior to bronchoscopy: eligible patients will have had a thin slice CT of the chest
performed as part of standard medical care within the preceding 14 days that will be
available to review during procedures.
2. Flexible bronchoscopy: procedures will be performed in an operating room or
dedicated endoscopy suite using either general anesthesia (typically) or moderate
sedation.  Following sufficient sedation, patients will be intubated using an endotracheal
tube no smaller than 8mm.  Flexible bronchoscopy will then be performed using the
conventional standard of care bronchoscope used at the hospital for airway inspection and
to provide topical anesthesia to the central tracheobronchial tree using 1-2% lidocaine as
per routine clinical practice.
3. Robotic assisted bronchoscopy: Following airway inspection and application of topical
anesthesia, the conventional thin bronchoscope will be removed and the Monarch
platform (Auris Health, Inc, Redwood City, CA) will be connected to the endotracheal
tube.  Navigation to the peripheral pulmonary lesion will be performed by advancing the
outer sheath and inner scope of the robotic bronchoscope to the targeted bronchus using a
control pad.  Once the outer sheath has been positioned appropriately, the inner scope
will be advanced into the lung periphery towards the targeted lesion using the Monarch
navigation (based on electromagnetic navigation and direct vision) as well as reference
CT images for guidance.
4. Radial probe endobronchial ultrasound: the radial endobronchial ultrasound probe (R-
EBUS) will be inserted into the working channel of the endoscope and advanced beyond
the tip of the inner scope as the inner scope is advanced into the lung periphery towards
the targeted lesion.  As the endoscope is guided towards the targeted lesion, R-EBUS will
confirm successful lesion localization prior to biopsies being performed.  If lesion
localization cannot be confirmed with R-EBUS, peripheral biopsies may still be
performed using the Monarch platform. In these cases, if rapid on-site evaluation is “non-
diagnostic”, the robotic bronchoscope will be removed and the bronchoscopist may
proceed to the salvage bronchoscopy procedure (as described below).
5. Biopsy: following lesion localization confirmation using R-EBUS, biopsy of the
peripheral lesion will be performed using transbronchial needle aspiration (TBNA) and
transbronchial biopsy (TBBx) as per standard clinical practice.  Should TBNA be
diagnostic using rapid on-site evaluation, no further biopsies are needed unless clinically
indicated.  Should rapid on-site evaluation be non-diagnostic from TBNA, a minimum of
3 TBNA and 3 TBBx will be performed, with the option to perform additional biopsies
using additional instruments at the discretion of the clinician.
6. Salvage procedures: in cases in which R-EBUS cannot confirm the successful
localization of peripheral lesions following use of the Monarch Endoscopy Platform
navigation, the robotic bronchoscope will be removed and the bronchoscopist may
proceed with peripheral bronchoscopy using flexible bronchoscopy and conventional
guided bronchoscopic approaches which may include electromagnetic navigation, virtual
bronchoscopic navigation and radial probe endobronchial ultrasound as per standard

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medical care.  R-EBUS will be used to confirm lesion localization prior to biopsy, which 
will be performed as outlined above in #4 and #5.   
7. ROSE: ROSE will be performed in all cases. Tissue samples will be plated on slides
for immediate on-site evaluation by the cytopathology team, as per the standard practice
of the Investigational centers. ROSE of acquired cytologic specimen will be performed in
all cases.
8. Following bronchoscopy: patients will be recovered in post-procedure recovery room
as per standard institutional practice.  A chest x-ray will be performed within 2 hours to
assess for pneumothorax. Prior to hospital discharge, the investigator and/or designee will
make sure that there are no SAE.
Duration of subject participation 
Once the subject has completed 24 hours follow-up (24-84 hours window) without study 
related adverse events requiring further follow-up, subject will be exited from the study. For 
the study procedure conducted on Friday, the 24-hours follow-up visit (phone call) is 
acceptable to be conducted on the following Monday.  
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 
24-84 hr 
phone 
call 
Study 
exit 
Informed Consent 
x 
 
 
 
 
 
Pregnancy Test (if applicable) 
x 
 
 
 
 
 
Preliminary Qualification 
(inclusion/exclusion criteria) 
x 
 
 
 
 
 
Medical History (pulmonary 
status) 
x 
 
 
 
 
 
Physical examination 
x 
 
 
 
Blood test and coagulation test 
(PT/INR)1 
x 
 
 
 
 
HRCTScan2 
x 
 
 
 
 
 
Fluoroscopy3 
 
 
x 
 
 
 
 Radial probe Endobronchial 
ultrasound (R-EBUS) 4 
 
 
x4 
 
 
 
Rapid on Site Evaluation 
(ROSE) 
 
 
x 
 
 
 
Chest X-ray5 
 
 
x5 
 
 
Concomitant medications6 
x 
x 
 
 
 
 
Follow-up Form  
 
 
 
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 as per standard 
institutional practices. 
2 The procedure will take place within 14 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 R-EBUS will be used to confirm the presence of a lesion. 
5 Chest X-ray within 2 hours from the conclusion of the procedure. 

 
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6 Aspirin, clopidogrel and oral anticoagulants will be stopped as per routine clinical practice and coagulations tests 
will be performed before procedure. Anticoagulants will be restarted 24 hours 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 pregnancy will be 
assessed with self-reporting 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 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.   
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 14 days pre-procedure as part of screening assessment. Specific 
CT parameters for scanner model and manufacturer will be provided to the site.  
Fluoroscopy. Fluoroscopy will be used in conjunction with the bronchoscopy to provide 
an additional viewing method during the procedure. 
Radial probe endobronchial ultrasound (R-EBUS). R-EBUS will be used to confirm the 
presence of a lesion. 
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.  
Follow-up.  The 24 hours (24-84 hours) follow-up will be a phone consultation. 
 

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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) in all cases.  A 
preliminary diagnosis will be recorded. The final histopathologic diagnosis will be 
recorded on the 24-84 hours follow-up CRF. 
Follow-up 
The subject will have a follow-up phone call on day 1 post procedure (24-84 hours to 
accommodate procedure performed on Friday). Study coordinator or principal investigator 
will make 3 attempts within 24-84 hours follow-up window to reach the patients. The 24-84 
hours CRF will be completed following the call. 
Study Exit 
Once the subject has completed 24-hours 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.  Data 
entry of the final biopsy diagnosis in non-diagnostic and indeterminate cases should be 
entered when available.   
Criteria for Terminating Study 
Auris Health, 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 Health, Inc to suspend or discontinue development of
the device.
Criteria for Suspending/Terminating a Study Center 
Auris Health, 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 Health, Inc. within 24 hours of
knowledge.

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4.3 Investigational product 
The Auris Bronchoscope is the patient interfacing component of the Monarch Endoscopy 
Platform. Additional components of the platform are Auris Cart (AC) and the Auris 
Tower.  The current platform received 510(k) clearance as a Class II device in March 
2018. The system has several components that interface to the Auris Cart including: The 
Fluidics Control, Electro-Magnetic Field generator, and Reference Electro-Magnetic 
sensors. 
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 2. Auris Bronchoscope 
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. 
Auris Cart 
The Auris Cart (AC) is a carrier for the robot arms. It includes two 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 Auris 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.  
Bronchoscope 
Sheath 

 
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An Emergency Stop button (Estop) sits on the Auris Cart and is positioned such that a 
clinical assistant has easy access to it. 
The following image shows the Auris Cart with the arms in the stow position (left) and 
load bronchoscope position (right): 
 
 
 
Figure 3. Auris Cart 
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 4. 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: 
 
Figure 5. Auris Endoscopy Controller 

 
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Auris Cart External Components 
 
The system has several components that interface to the Auris 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. 
 
Device Distribution 
The Monarch platform will be provided free of charge to the investigator for his exclusive 
use in this study for 45 calendar days. The first day will be considered the first Monday 
following the completion of the required PI and staff training. The robotic bronchoscopes 
and other disposables required to perform the robotic bronchoscopy procedure with the 
Monarch Endoscopy Platform will be provided free of charge. Unused bronchoscope and 
disposables will be returned to Auris. 
Device Accountability 
Auris Health and Investigative Sites will maintain device accountability as required for this 
Study. 
Return of Materials Upon Study Termination 
Unless other arrangements have been made, the Monarch platform will be returned to Auris 
at the end of the 45 days enrollment. All used bronchoscopes may be returned to Auris for 
examination after every case. 
 
5. Criteria for subject withdrawal 
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 

 
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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 ABS 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. 
5.1 Subject inclusion criteria 
Pre-Procedure 
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 1-5cm 
in size identified on thin slice CT scan within 14 days of the intended 
bronchoscopy 
5. Lack bleeding disorders  
 
5.2 Subject exclusion criteria 
Pre-Procedure 
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. Patients with a subsolid nodule and/or ground-glass opacity lesions on 
pre-procedure chest CT 
3. Patients with endobronchial involvement seen on chest CT 
4. Lack fitness to undergo flexible bronchoscopy as determined by the 
bronchoscopist prior to procedure, and  
5. Participation in any other investigational clinical trial (device or 
medication) 30 days before and throughout the duration of the study; 
6. Uncontrolled or irreversible coagulopathy; 
7. Female subjects who are pregnant or nursing or those of child-bearing 
potential refusing a pregnancy test; 
8. Have significant mediastinal lymphadenopathy on chest CT scan and/or 
PET CT abnormalities suggestive of advanced stage lung cancer with 
mediastinal lymph node involvement 
 
 
 
 

 
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In addition, 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. 
 
6. Treatment of subjects 
 
This study is not associated with any treatment. The bronchoscopy procedure to obtain a 
biopsy sample for diagnostic purposes is previously described in this protocol. 
 
7. Assessment of efficacy 
 
Primary Effectiveness Endpoint 
 
The primary effectiveness endpoint is the successful navigation to targeted peripheral 
pulmonary lesions sized 1-5cm as confirmed using radial probe endobronchial 
ultrasound. Radial probe endobronchial ultrasound will be used in all cases to confirm the 
presence of a lesion immediately before performing biopsy. 
 
Secondary Effectiveness Endpoint 
The following will be considered secondary endpoints: 
o Time to R-EBUS confirmation (lesion localization) 
o Time to the tissue acquisition confirmation 
o Total procedure time (from introduction to removal of the bronchoscope) and 
procedure interruptions 
o Radiographic and procedural factors that influence the ability to successfully 
navigate to peripheral lesions including size and location of peripheral lesions 
o Diagnostic yield 
o Conversion to conventional bronchoscopic procedure (salvage procedure) 
 
Time to R-EBUS confirmation: Is defined by the time the ABS 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 ABS bronchoscope 
is inserted into the oropharynx until the tissue acquisition is confirmed by the ROSE. 

 
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Total procedure time: Total procedure time is defined by the time the ABS bronchoscope 
is inserted into the oropharynx until the time a biopsy tool is removed. 
Procedure interruptions:  The sum of procedure interruptions due to platform 
malfunctions  
Radiographic and procedural factors that influence the ability to successfully navigate to 
peripheral lesions including size and location of peripheral lesions: the following factors 
will be considered: 
• Lesion size (recorded as the longest axis diameter) 
• Lesion Location  
• Presence or absence of a visible bronchus 
• Procedure duration (measured from time of scope insertion) 
• Type and amount of sedation provided 
• Ability to localize peripheral lesions as confirmed by R-EBUS 
• R-EBUS image characterization (concentric vs eccentric) 
• Proximity of RES scope to peripheral lesion at the time of biopsy 
• Distance of lesion from main carina as measured by electromagnetic navigation 
• Bronchus generation count accessed by the Monarch 
• Need to convert to salvage procedures 
• Procedural time from scope in to scope out and total time if salvage procedure 
performed. 
• Distance from scope to the targeted nodule as measured by navigation 
  
Diagnostic yield will be determined from the results of the bronchoscopy. A biopsy that 
results in a specific diagnosis, either malignant or benign, will be assumed to be a true 
positive. Follow up of non-diagnostic or indeterminate biopsy results will be performed 
as clinically indicated.  The diagnosis of “inflammation” will be considered diagnostic if 
follow up imaging results in improvement or resolution of the targeted lesion.  In cases 
where the lesion is unchanged or has increased in size, the description of “inflammation” 
will be considered non-diagnostic. 
Conversion to conventional bronchoscopic procedure:  
Number of the procedure converted to the conventional bronchoscopy for any reason. 
 
8. Assessment of safety 
 
Primary Safety Endpoint 
Number of device related adverse events. 
Secondary Safety Endpoint 
Number of complications unrelated to device. 

 
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Adverse Events 
All adverse events (AE) and serious adverse events (SAE) will be monitored from the time 
of enrollment through the study exit.  
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: 
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 MONARCH PLATFORM 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 MONARCH PLATFORM 

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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 MONARCH PLATFORM AND is not otherwise specific to the MONARCH PLATFORM 
(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 MONARCH PLATFORM 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 determine if the event may be more appropriately classified as device-
related or procedure-related. 
Site PIs will be responsible for identifying adverse events during the procedure and 
during the standard of care follow-up period. Site PIs will review adverse events 
experienced by subjects treated at their site during the procedure standard of care follow-
up period and will record them in the medical record. Site PIs will review all adverse 
events, expected or unexpected, per standard medical care.  
Site PIs will classify AEs as expected or unexpected, and report AEs directly to the sponsor 
and IRB per local IRB reporting policy. The lead investigator will capture all AEs occurring 
at all sites, including unanticipated AEs, in the electronic data capture instrument. Auris 
Health, Inc., or its designee, may assist the Investigator in determining 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.   

 
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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 EC of serious adverse events 
as required by their EC procedures and in conformance with FDA and local regulatory 
requirements. 
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: 
Auris Health, Inc 
150 Shoreline Dr 
Redwood City, CA 94065 
Attn:  Emir Deljkich 
Email: emir.deljkich@aurisrobotics.com 
Phone: (650) 743-4346 
Device Failures and Malfunctions 
All reported device observations, malfunctions or failures of the MONARCH ENDOSCOPY 
PLATFORM  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. 
 
9. Statistical Methods  
Descriptive statistics will be calculated to characterize study subjects and endoscopic 
procedures, and will include the mean±SD for continuous variables and percentages for 
categorical variables, such as subject’s age, location of peripheral lesions, ultrasound 

 
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characteristics, duration of procedure, type and amount of sedation administered, and 
adverse events. 
 
10. Access to source documentation 
The Principal Investigator must maintain detailed source documents on all Study subjects 
who are enrolled in the Study or who undergo screening. Additionally, the 
investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB review and 
regulatory inspection(s) by providing direct access to source data and documents.  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. 
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 be 
retained for a longer period of time by agreement with Auris Health, 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 Health, Inc must receive written notification of this custodial change.  
 

 
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11. Quality control and quality assurance 
 
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. 
Physician Training 
Prior to enrolling subjects in the Study, investigators will be provided didactic training on 
the procedural steps required to use the Monarch platform.  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 Monarch platform. 
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 Study. 
Amending the Protocol 
An Investigator may not make protocol changes without prior approval by Auris Health.  
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 Health 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. 

 
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Emergency Actions 
Auris Health, 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 Health, Inc and the IRB as quickly as possible after the episode, 
in any event no later than 24 hours after the emergency. 
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. 
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 Health regardless of whether medically justifiable, 
pre-approved by Auris Health 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 the STUDY DEVICES outside the study, 
unauthorized use of the STUDY DEVICES by a physician who has not signed an Investigator 
agreement or not been trained in the use of the devices, etc.), will be reported to Auris 
Health 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. 
Coverage of Expenses 
The treated subjects will not be reimbursed or compensated for participating in the Study. 

 
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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. 
 
12. Ethics 
 
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. 
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 EC for written approval.  
A copy of the written EC approval of the protocol and Informed Consent form must be 
received by Auris Health, Inc. before recruitment of patients into the study.  
The Investigator must submit and, where necessary, obtain approval from the IRB 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 
Health 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 Health.  
Informed Consent Form 
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, 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 screening observations may demonstrate that 
the patient is not a suitable candidate for the study.  
Informed consent will take place in a private environment (e.g. patient exam room), free 
from distractions. The PI will approach the subject at their standard of care clinic 
appointment or prior to their scheduled study procedures and will explain the study to 
qualified subjects prior to obtaining consent. Interviews to obtain consent will not follow 

 
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any stressful situation (e.g. patient being informed he/she may have cancer) and will not be 
conducted if the patient has received any mind-altering medications or anesthesia. Patients 
will be assessed for their capacity to consent by the ability to show comprehension of the 
procedure, ask appropriate questions, and appear properly oriented. A signed copy of all 
consents and the HIPAA authorization document will also be given to consenting subjects. 
A Screening/Enrollment Log will be maintained to document select information about 
candidates who fail to meet the entry criteria. 
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. 
Investigator Responsibilities 
• 
Agree to sign and adhere to the Investigator Agreement 
• 
Agree to participate in Investigator meetings as scheduled by Auris Health, 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 
• 
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 
 
13. Data Handling and recordkeeping 
 
Standardized electronic CRFs will be utilized by participating site using a standardized 
database.  Electronic data capture system will be used in this study.  Investigator is 

 
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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).  Data entry of the 
final biopsy diagnosis in non-diagnostic and indeterminate cases should be entered when 
available.   
The PI will review the results, and the results will become part of the subject’s medical 
record and research record. Any clinical follow-up or repeat procedures will be dictated 
by the patient’s physician based on clinically relevant data and will not be influenced by 
enrollment into this study. All patient information will be de-identified through use of the 
6-digit patient codes. All information and data related to this study will be stored in a 
secured, locked cabinet in a secure office accessible only by the PI.  
Prior to each site initiation, the site PI and staff will participate in an educational 
teleconference with the Coordinating Site PI to ensure that all personnel fully understand 
the protocol, data collection instrument, and any other study related issues or documents. 
Contact information, including the phone and pager numbers for the principal 
investigators and study staff will be provided to all sites 
In minimum, data on the following will be collected at all sites: radiographic 
characteristics, procedural characteristics, diagnostic yield, and complications: 
 
1. Radiographic information: the radiographic information collected will include the 
following: 
a) 
Lesion size (recorded as the longest axis diameter) 
b) 
Location  
c) 
Presence or absence of a visible bronchus 

 
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2. Procedural characteristics: procedural information will include the following: 
a) 
Room preparation time 
b) 
Robot set-up time 
c) 
Procedure duration (measured from time of scope insertion) 
d) 
Type and amount of sedation provided 
e) 
Ability to localize peripheral lesions as confirmed by R-EBUS 
f) 
R-EBUS image characterization (concentric vs eccentric) 
g) 
Proximity of RES scope to peripheral lesion at the time of biopsy 
h) 
Distance of lesion from main carina as measured by electromagnetic guidewire 
i) 
Need to convert to salvage procedures 
j) 
Procedural time from scope in to scope out and total time if salvage procedure 
performed. 
 
3. Diagnostic yield: diagnostic yield will be determined from the results of the 
bronchoscopy. A biopsy that results in a specific diagnosis, either malignant or benign, 
will be assumed to be a true positive. Follow up of non-diagnostic or indeterminate 
biopsy results will be performed as clinically indicated and data entry of the final biopsy 
diagnosis in non-diagnostic and indeterminate cases should be entered when available.  
The diagnosis of “inflammation” will be considered diagnostic if follow up imaging 
results in improvement or resolution of the targeted lesion.  In cases where the lesion is 
unchanged or has increased in size, the description of “inflammation” will be considered 
non-diagnostic.  
 
4. Complications: the following complications will be recorded: 
a) 
Pneumothorax as indicated by post-procedure chest radiograph 
a. Need for tube thoracostomy 
b) 
Bleeding with severity determined by the need for intervention such as blood 
transfusion, inpatient hospitalization or escalation in level of care 
 
Data Safety Monitoring Plan 
All subjects enrolled in the trial will undergo routine standard of care bronchoscopy that 
is indicated as medically necessary by their physicians. Prior to the bronchoscopic 
procedure, PIs will explain the risks associated with bronchoscopy, and verify that the 
research only risks have been explained, and that the subject has signed an informed 
consent form. There are no anticipated risks, outside of the risk for the standard of care 
procedures for this clinical trial. All subjects are required to read, understand, and sign 
the informed consent form associated with the research study. Each subject will be 

 
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informed of post procedure symptoms of which to be aware that may represent adverse 
reactions to the bronchoscopy.  Symptoms that the patient will be informed to look out 
for include: 
• Pain or difficulty with swallowing 
• Difficulty breathing 
• Vomiting 
• Dizziness 
• Abdominal or chest pain 
• Continuous bright red blood in your sputum 
• Fever above 100.0 degrees Fahrenheit 
If the subject notes any of these symptoms, he/she is instructed to contact his/her 
physician, who will determine the course of action. All events are to be reported within 
48 hours of occurrence to the coordinating site (WUSM).  All adverse events (AEs) will 
be reviewed by the medical monitor within one month of their occurrence and 
summarized for review.  The PI at each site will be responsible for submitting this report 
to the IRB at his/her institution as required. AEs and other reportable events are defined 
below. 
 
14. 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 
original source documents by Auris Health, 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 

 
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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. 
 
15. Compensation, Insurance and Indemnity 
 
The financial agreement, insurance and indemnity between sponsor and investigators are 
provided in separate agreements. 
16. 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 Health, 
Inc.  These data may be used by the Sponsor and Investigators 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. 
 
 

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17.Appendices
17.1 Appendix I 
References: 
1. Aberle DR, Adams AM, Berg CD, et al. Reduced lung-cancer mortality with low-dose
computed tomographic screening. The New England journal of medicine 2011; 365:395-
409
2. Chen AC, Loiselle A, Zhou L, Baty J, Misselhorn D. Localization of peripheral
pulmonary lesions using a method of CT-anatomic correlation and radial probe
endobronchial ultrasound. Ann Am Thorac Soc 2016, 13(9):1586-1592.
3. Silvestri GA, Vachani A, Whitney D, Elashoff M, Ferguson JS, et al. A bronchial
genomic classifier for the diagnostic evaluation of lung cancer. N Engl J Med 2015,
16;373:243-251.
4. Ost DE, Ernst A, Lei X, Kovitz KL, Benzaquen S, et al. Diagnostic yield and
complications of bronchoscopy for peripheral lung lesions. Results of the AQuIRE
registry. Am J Respir Crit Care Med 2016, 193(1):68-77.
5. Veronesi, G. Roboic lobectomy and segmentectomy for lung cancer: results and
operating technique. Journal of Thoracic Disease 2015;7:S122-130.
6. Chen AC, Gillespie C. Robotic endoscopic airway challenge: REACH assessment. Ann
Thorac Surg 2018 (in press).

 
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17.2 Appendix II 
 
Regulatory Considerations 
 
Auris Health, 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. 
 
Role of Auris Health 
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 or Clinical Research 
Organization (CRO).  Together, both Auris and its Consultants and CRO 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 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.  
 
Pre-Study Documentation Requirements 
Prior to shipment of product, the following documents must be provided to Auris Health, 
Inc: 
• 
Signed and dated Investigator Agreement 
• 
A copy of the written EC approval of the protocol  
• 
A copy of the written EC approval of the Informed Consent Form  
• 
A copy of the curriculum vitae of the Principal Investigator and Co-Principal 
Investigator (if applicable) 
General Duties [21 CFR 812. 40] 
No IDE application to FDA is required for this 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 

 
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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. 
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. 
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 EC re-approval.  No FDA submissions are required. 
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.   
Submitting Reports [21 CFR 812. 150 (B)] 
No FDA submissions are required for the Study. 
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-market 
approval application.  Record retention dates will be provided to all concerned by the 
sponsor. 
Informed Consent & Institutional Review Board/Ethic Committee [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 EC.  The site must provide the Sponsor 
with a copy of the clinical site’s EC 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). 

 
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17.3 Appendix III 
 
Study Centers: 
 
 
Institution 
Location 
Investigators 
Washington University 
School of Medicine 
 
 
660 S. Euclid Avenue 
St. Louis, MO 63110 
PI: Alexander Chen, M.D., Lead 
Investigator 
Co-PI: N/A 
Henry Ford Health System 
2799 W Grand Blvd 
IM - Pulmonary K-17 
Detroit, MI 48202 
PI: Michael Simoff, M.D. 
Cleveland Clinic 
9500 Euclid Avenue 
Cleveland, OH 44195 
PI: Thomas Gildea, M.D. 
Co-PI: Michael Machuzak, M.D. 
Co-PI:  Joseph Cicenia, M.D. 
 
Medical University of South 
Carolina 
171 Ashley Avenue 
Charleston, SC 29425 
PI: Gerard Silvestri, M.D. 
Co-PI: Nicholas Pastis, M.D. 
 
Inova Fairfax Hospital 
921 Telestar Ct 
Falls Church, VA 22042 
PI: Amit Mahajan, M.D. 
 
Coordinating Center: 
 
Washington University School of Medicine 
660 S. Euclid Avenue 
St. Louis, MO 63110 
Alexander Chen, MD 
Note: Study centers not executing the Clinical Trial Agreement will not participate in the study. 
 
 

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17.4 Appendix IV 
IRB Names: 
IRB information will be kept separately.