Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue Acquisition System With Real-time Visualization for Collection of Cytology Specimens of Peripheral Pulmonary Lesions
Phase: NA
Conditions: Solitary Pulmonary Nodule, Biopsy, Fine-Needle
Sponsor: Boston Scientific Corporation

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Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue 
Acquisition System with Real-time Visualization for Collection of Cytology 
Specimens of Peripheral Pulmonary Lesions 
 
iNod Feasibility 
 
CLINICAL PROTOCOL 
 
PDM# 91122035 
Project # E7113 
 
 
Sponsored By 
Boston Scientific Corporation 
100 Boston Scientific Way 
Marlborough, MA 01752-1234 
USA 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
THESE DOCUMENTS ARE THE PROPERTY OF BOSTON SCIENTIFIC CORPORATION AND SHALL NOT BE REPRODUCED, 
DISTRIBUTED, DISCLOSED OR USED FOR MANUFACTURE OR SALE OF APPARATUS WITHOUT THE EXPRESS WRITTEN 
CONSENT OF BOSTON SCIENTIFIC CORPORATION. 

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Confidential 
 
 
 
 
 
Contact Information 
 
Role 
Contact 
Clinical Contact 
G Mark Grubb, RN 
Clinical Project Manager 
Boston Scientific, Endoscopy Clinical Affairs 
100 Boston Scientific Way 
Marlborough, MA 01752 
mark.grubb@bsci.com 
Coordinating Principal 
Investigators 
Alex Chen, MD 
Co-lead Investigator 
Washington University School of Medicine 
St. Louis, Missouri 
Lonny Yarmus, DO 
Co-Lead Investigator 
Johns Hopkins University 
Baltimore, Maryland 
 
Original Release: March 14, 2016 
Current Version: March 14, 2016 

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Protocol Synopsis 
 
Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue 
Acquisition System with Real-time Visualization for Collection of Cytology 
Specimens of Peripheral Pulmonary Lesions 
Objective(s) 
To demonstrate feasibility to access, visualize, and obtain specimens 
adequate for cytology of lung lesions in subjects with suspected lung 
cancer when using the iNod System. 
Planned 
Indication(s) for 
Use 
The iNod System is intended for use for diagnostic ultrasound imaging 
and ultrasound-guided fine needle aspiration (FNA) of extramural and 
submucosal lesions of the tracheobronchial tree. 
Test Device 
The iNod System, is comprised of the following components: 
• iNod Ultrasound Imaging System 
• iNod Ultrasound Catheter 
• iNod Biopsy Needle 
• iNod Motor Drive Unit 
• iNod Sled 
The iNod Biopsy Needle and the iNod Ultrasound Catheter are intended 
to be used, in combination, in the Olympus BF-P190 or Olympus BF- 
MP160 Bronchoscopes. 
Study Design 
Multi-center, Prospective, Single-arm Feasibility Study with Salvage. 
Number of 
Subjects 
5 to 10 Subjects at a study center 
15 to 30 Subjects, across all study centers 
Number of 
Centers / 
Countries 
2-3 US Study Centers 
Primary 
Endpoint 
Clinical success is defined as the iNod System’s ability to acquire 
adequate specimens of cellular matter suitable for the cytologic 
evaluation of targeted lung lesions, under real-time visualization. 
Salvage Procedure: In case of primary endpoint failure with the iNod 
System, Radial EBUS -guided diagnostic sampling maneuvers (current 

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Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue 
Acquisition System with Real-time Visualization for Collection of Cytology 
Specimens of Peripheral Pulmonary Lesions 
standard-of-care) will be performed in an attempt to access, visualize, and 
sample targeted lung lesions. 
Secondary 
Endpoints 
1. Occurrence and severity of Adverse Events related to the iNod System 
biopsy procedures, as well as Adverse Events related to any 
subsequent Radial EBUS-guided salvage procedures. 
2. Proportion of lesions visualized during iNod Maneuvers 
3. Proportion of lesions accessed where iNod Biopsy Needles were 
deployed in the target lesion during study maneuvers 
4. Proportion of iNod maneuvers that acquire specimens of cellular 
matter for cytology 
Study Visit 
Schedule 
Baseline Visit: Informed Consent, Medical History, including collection 
of a Chest CT image within 6 weeks of study procedure, which confirms 
the presence of peripheral pulmonary lesion(s). 
Bronchoscopy Procedure: iNod sampling of lesion followed by additional 
standard of care (salvage) procedures, should collected specimens be 
determined as inadequate for cytologic evaluation. Intra-procedural 
specimens collected for cytology will be documented. 
Completion / End of Study: 
• Following the bronchoscopic procedure, and per standard clinical 
practice, the subject will have a post-procedure chest x-ray. 
• The subject will have a Day 7 Post-Procedure Safety Call to check 
for any delayed-onset Device/Procedure/Anesthesia-related safety 
events. 
Study Duration 
The study will close after enrollment is completed. The enrollment 
period is estimated to be open for approximately 1 year from First Patient 
In (FPI) through Last Patient Out (LPO). Follow-up of unforeseen 
procedure-related safety events could extend LPO beyond the date of the 
last study procedure. 

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Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue 
Acquisition System with Real-time Visualization for Collection of Cytology 
Specimens of Peripheral Pulmonary Lesions 
Key Inclusion 
Criteria 
1. Subject is age 18 years or older. 
2. Subject is willing and able to comply with study procedures and 
provide written informed consent to participate in study. 
3. Subject with a predominantly solid lung lesion, 1 cm to 7 cm in 
diameter, which has been identified on chest CT (obtained within 6 
weeks) with the intention to undergo a clinically indicated 
bronchoscopic evaluation under routine clinical care. If the lesion is 
partially solid (i.e. there is a ground glass component) then the solid 
portion must make up 80% of the lesion. 
4. Subject for whom the decision to pursue biopsy has been made by the 
treating physician and agreed upon by the subject. 
Key Exclusion 
Criteria 
1. Subjects with pure ground glass opacity, a subsolid target lesion, 
and/or a ground glass opacity identified on Chest CT. 
2. Subjects with lesions that include endobronchial involvement, per 
Chest CT. 
3. Subjects who lack fitness to undergo flexible bronchoscopy and 
standard of care Radial EBUS-guided cytological assessment 
evaluations, as determined by the investigator. 
4. Subjects with known coagulopathy. 
5. Subjects who are pregnant or nursing mothers. 
6. Subjects who are currently enrolled in another investigational study 
that would directly interfere with the current study, without prior 
written approval from the sponsor. 
Statistical Methods 
Primary 
Statistical 
Hypothesis 
There will be no formal statistical hypothesis tested since this is an 
observational feasibility study documenting the first human use of the 
iNod System. 
Statistical Test 
Method 
Descriptive statistics will be presented to characterize the trial data and 
describe the trial results. 

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Feasibility Study of a Bronchoscopic Ultrasound-Guided Tissue 
Acquisition System with Real-time Visualization for Collection of Cytology 
Specimens of Peripheral Pulmonary Lesions 
Sample Size 
Parameters 
Since no formal hypothesis will be tested, there is no statistical 
justification of sample size. 
Peripheral pulmonary lesions vary in their location in the 
tracheobronchial tree, their size, and their characteristics (e.g., concentric 
vs. eccentric). A sample size of 5-10 subjects per site allows greater 
potential to evaluate the usability and performance of the system for 
visualization and sampling this range of lesions. 
Performance feedback for this traditional feasibility study is sought from 
more than 1 physician. While staying within the sample size confines of a 
traditional feasibility study, Boston Scientific has elected to seek the 
expertise of 2 to 3 interventional bronchoscopists. 

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Table of Contents 
PROTOCOL SYNOPSIS ............................................................................................................................................. 3 
TABLE OF CONTENTS ............................................................................................................................................. 7 
Table of Tables ................................................................................................................. 10 
1. 
INTRODUCTION .............................................................................................................................................. 11 
2. 
DEVICE DESCRIPTION ................................................................................................................................. 12 
2.4. Medical Equipment Description ........................................................................... 15 
3. 
OBJECTIVES .................................................................................................................................................... 15 
4. 
ENDPOINTS ...................................................................................................................................................... 15 
5. 
DESIGN, SCALE, AND DURATION ............................................................................................................ 16 
6. 
SUBJECT SELECTION ................................................................................................................................... 16 
6.1 
Inclusion Criteria ................................................................................................... 16 
6.2. Exclusion Criteria .................................................................................................. 17 
7. 
SUBJECT ACCOUNTABILITY ..................................................................................................................... 17 
7.1. Point of Enrollment ................................................................................................ 17 
7.2. Withdrawal ............................................................................................................. 17 
7.3. Enrollment Controls .............................................................................................. 18 
8. 
STUDY METHODS .......................................................................................................................................... 18 
8.1. Data Collection ....................................................................................................... 18 
8.2. Study Candidate Screening ................................................................................... 20 
8.3. Informed Consent ................................................................................................... 20 
8.4. Baseline.................................................................................................................... 20 
8.5. iNod Diagnostic Procedure .................................................................................... 20 
8.6. Salvage Procedure .................................................................................................. 22 
8.7. Study Completion ................................................................................................... 22 
8.8. Source Documents .................................................................................................. 22 
9. 
STATISTICAL CONSIDERATIONS ............................................................................................................. 23 

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9.1. Endpoints ................................................................................................................ 23 
9.1.1. 
Primary Endpoint ...................................................................................... 23 
Hypotheses ................................................................................................ 23 
Sample Size ............................................................................................... 23 
Statistical Methods .................................................................................... 24 
9.2. General Statistical Methods .................................................................................. 24 
9.2.1. 
Analysis Sets .............................................................................................. 24 
Intent-to-Treat Cohort .............................................................................. 24 
Per Protocol Cohort .................................................................................. 24 
9.2.2. 
Control of Systematic Error/Bias .............................................................. 24 
9.2.3. 
Number of Subjects per Investigative Site ................................................. 24 
9.3. Data Analyses ......................................................................................................... 24 
9.3.1. 
Interim Analyses ........................................................................................ 25 
9.3.2. 
Subgroup Analyses ..................................................................................... 25 
9.3.3. 
Justification of Pooling .............................................................................. 25 
9.3.4. 
Changes to Planned Analyses .................................................................... 25 
10. DATA MANAGEMENT .................................................................................................................................. 25 
10.1. Data Collection, Processing, and Review ............................................................. 25 
10.2. Data Retention ........................................................................................................ 26 
11. AMENDMENTS ................................................................................................................................................ 26 
12. DEVIATIONS .................................................................................................................................................... 26 
13. DEVICE/EQUIPMENT ACCOUNTABILITY ............................................................................................. 27 
14. COMPLIANCE .................................................................................................................................................. 27 
14.1. Statement of Compliance ....................................................................................... 27 
14.2. Investigator Responsibilities ................................................................................. 28 
14.2.1. Delegation of Responsibility ...................................................................... 30 
14.3. Institutional Review Board .................................................................................... 30 
14.4. Sponsor Responsibilities ........................................................................................ 30 
14.4.1. Role of Boston Scientific Representatives .................................................. 31 
14.5. Insurance ................................................................................................................. 31 
15. MONITORING .................................................................................................................................................. 31 
16. POTENTIAL RISKS AND BENEFITS .......................................................................................................... 32 

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16.1. Anticipated Device-related & Procedure-related Adverse Events .................... 32 
16.2. Risks Associated with the Study Device(s) ........................................................... 33 
16.3. Risks associated with Participation in the Clinical Study .................................. 33 
16.4. Risk Minimization Actions .................................................................................... 33 
16.5. Anticipated Benefits ............................................................................................... 33 
16.6. Risk to Benefit Rationale ....................................................................................... 33 
17. SAFETY REPORTING .................................................................................................................................... 34 
17.1. Reportable Events by Investigational Site to Boston Scientific ......................... 34 
17.2. Relationship to Study Device(s) ............................................................................ 36 
17.3. Investigator Reporting Requirements .................................................................. 36 
17.4. Boston Scientific Device Deficiencies .................................................................... 37 
17.5. Reporting to Regulatory Authorities / IRBs / ECs / Investigators ..................... 38 
18. INFORMED CONSENT ................................................................................................................................... 38 
19. SAFETY MONITORING PROCESS ............................................................................................................. 39 
20. SUSPENSION OR TERMINATION ............................................................................................................... 40 
20.1. Premature Termination of the Study .................................................................... 40 
20.1.1. Criteria for Premature Termination of the Study ......................................... 40 
20.2. Termination of Study Participation by the Investigator or Withdrawal of IRB/ 
EC Approval ........................................................................................................... 40 
20.3 Requirements for Documentation and Subject Follow-up ................................. 40 
20.4 Criteria for Suspending/Terminating a Study Center ........................................ 41 
21. PUBLICATION POLICY ................................................................................................................................. 41 
22. BIBLIOGRAPHY .............................................................................................................................................. 42 
23.2. Definitions ............................................................................................................... 44 

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Table of Tables 
Table 6.1-1: Inclusion Criteria ................................................................................................ 16 
Table 6.2-1: Exclusion Criteria ............................................................................................... 17 
Table 8.1-1: Data Collection Schedule ................................................................................... 19 
Table 8.8-1: Source Documentation Requirements .............................................................. 223 
Table 17.1-1: Safety Reporting Definitions ............................................................................ 34 
Table 17.2-1: Criteria for Assessing Relationship of Study Device to Adverse Event .......... 36 
Table 17.3-1: Investigator Reporting Requirements ............................................................... 36 
Table 23.1-1: Abbreviations ................................................................................................... 43 
Table 23.2-1: Definitions ........................................................................................................ 44 

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1. Introduction 
 
This protocol is a traditional feasibility study for the sampling of a peripheral pulmonary 
lesion in the setting of a suspicion of lung cancer. Standard of practice radial endobronchial 
ultrasound (R-EBUS) transbronchial needle aspiration (TBNA) is visualizing a peripheral 
lesion on R-EBUS, locking the placement of the access sheath, removing the ultrasound 
catheter from the access sheath and then blindly advancing a sampling device to acquire 
cellular matter for cytologic evaluation. The iNod system performs the same procedure with 
one fewer device exchange. It provides real-time visualization of the biopsy needle and target 
peripheral pulmonary lesions during tissue acquisition. The ultrasound probe is not retracted 
in advance of the sampling maneuver and the sampling is completed under direct 
visualization. Compared to current standard of care methods for transbronchial sampling of 
pulmonary lesions, this approach is not expected to add additional risk. Tissue sampling 
under real-time visualization may improve the efficiency of tissue sampling. 
Lung cancer is the most common cancer worldwide; accounting for 1.8 million new cases 
and 1.6 million deaths in 2012.1 Lung CA is also the leading cancer killer in both men and 
women in the United States.2 The number of deaths caused by lung cancer has increased 
approximately 3.5 percent between 1999 and 2012 from 152,156 to 157,499. In 2012, there 
were 86,740 deaths due to lung cancer in men and 70,759 in women.2 The five year survival 
rate for lung cancer is 54 percent for cases detected when the disease is still within the lungs. 
However, only 15 percent of lung cancer cases are diagnosed at an early stage. For distant 
tumors (spread to other organs) the five-year survival rate is only 4%.3 
Pulmonary lesions are a common but difficult issue for primary care and specialty physicians 
and are often found incidentally on Chest X-Ray (CXR) or Computed Tomography (CT) 
scan.4 With the results of the National Lung Cancer Screening Trial demonstrating a 
reduction in lung cancer mortality with screening of high risk patients with low dose CT 
scan, the number of nodules detected requiring follow up is likely to increase exponentially 
as 25% of those screened had a detected lung abnormality.5 In studies of incidentally 
detected nodules, the prevalence of malignancy ranges from 2-82% 6. The problem for 
clinicians is deciding on the management and further diagnostic modalities to pursue. 
The various recommended procedures for obtaining tissue diagnosis in these intermediate 
cases include transthoracic needle aspiration (TTNA), surgery, and flexible bronchoscopy 
(FB). The diagnostic yield with FB varies with lesion size and location. A lesion having a 
bronchus sign (the finding of a CT-visible bronchus leading to the lesion) increases the 
success of transbronchial biopsy and brushing.7_ENREF_7 The ACCP recommends that 
nodules without a CT-bronchus sign should be pursued with TTNA unless radial 
endobronchial ultrasound (R-EBUS) is available.8_ENREF_6 Bronchoscopy is commonly 
used for pulmonary masses, but the yield, while high, does not approach 100%. 
Endobronchial ultrasound (EBUS) and radial EBUS (R-EBUS) are known to be safe and 
effective imaging techniques for transbronchial and endobronchial biopsy.9, 10 The location of 
the bronchoscope at the lesion can be verified with real-time visualization with the guide 
sheath acting as an extended working channel to maintain the location during R-EBUS 

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biopsy. Increased use of screening CT scans has led to the increased detection of pulmonary 
lesions and nodules. 
The intent of this clinical study is to demonstrate feasibility to visualize, access, and obtain 
specimens adequate for cytology of lung lesions in subjects with suspected lung cancer when 
using the iNod System. 
 
2. Device Description 
 
The iNod system enables real-time visualization and biopsy of peripheral pulmonary lesions 
by displaying an ultrasound image of the lesion and needle simultaneously. Intended 
conditions of use are within a pulmonary endoscopy suite or a surgical suite. The iNod 
System consists of three components (and accessories) that are either identical to or slightly 
different in design to existing commercially available devices: 
• The iNod Biopsy Needle is a modified design of the commercially available 25 gauge 
BSC Expect Slimline Endoscopic Ultrasound Aspiration Needle. The modifications are 
limited to a modification of the sheath and the addition of a “needle stroke limiter” to the 
handle. The needle and stylet within the sheath, as well as the handle, remain unchanged. 
• The iNod Ultrasound Catheter is a slightly modified design of the commercially 
available BSC OptiCross Coronary Imaging Catheter. The modifications are limited to 
the absence of the distal guide catheter tip beyond the ultrasound transducer and the 
absence of a hydrophilic coating on the sheath. 
• The iNod Ultrasound Imaging System and its two accessories, the iNod Motor Drive 
Unit and the iNod Sled, are identical to the commercially available BSC iLab Ultrasound 
Imaging System and its accessories. 
The study system is not approved for commercial use. Local IRB (Institutional Review 
Board) approval will be obtained at each participating center. 
All components of the iNod System are labeled as investigational and include information 
not limited to name of legal manufacturer, device name and dimensions, lot number, 
expiration date and investigational use statement. 
 
2.1. Biopsy Needle 
 
The design of the iNod Biopsy Needle is based on the commercially available Boston 
Scientific 25 gauge Expect Slimline Endoscopic Ultrasound Aspiration (EUS-FNA) 
Needle (K133312, cleared January 3, 2014), with modifications to allow simultaneous 
use with the iNod Ultrasound Catheter. The modifications are limited to a modification of 
the sheath (replacing the single extrusion sheath with a multi-component single-lumen 
exterior tube) and the addition of a “needle stroke limiter” to the handle. The remainder 
of the Expect Slimline EUS-FNA Needle design, including the needle, stylet, and handle, 
is unchanged. 

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The iNod Biopsy Needle is a 103 cm long (nominal) needle that can be inserted into the 
working channel of bronchoscope. It is used for fine needle aspiration of lesions within 
the tracheobronchial tree. The iNod Biopsy Needle consists of a handle assembly and a 
sheath-covered needle in a single lumen of sufficient diameter to simultaneously 
accommodate the needle/stylet assembly and the iNod Ultrasound Catheter. The needle 
has echogenic features at the distal end to facilitate real time visualization of the device 
under ultrasound. At the proximal end of the sheath, a Y-port with a Tuohy Borst valve 
allows the iNod Ultrasound Catheter to be inserted into the lumen parallel to the needle. 
The handle assembly on the proximal end of the device is used to actuate the needle in 
order to gather specimens. The “needle stroke limiter” on the handle limits the needle 
extension length to a maximum of 2.5 cm. A stylet is in place within the needle to 
provide protection to the inside of the sheath during device passage through the 
bronchoscope. The stylet may also be used to expel the specimen after the procedure. A 
syringe and stopcock provide and control the vacuum suction to aspirate the specimen, 
and can be used to expel the specimen after the procedure. The iNod Biopsy Needle 
retains certain features of the Expect Slimline EUS-FNA Needle upon which it is based 
that will not be utilized in this study (e.g. sheath and adjustment knob and lock). 
 
2.2. iNod Ultrasound Catheter 
 
The iNod Ultrasound Catheter is a modified design of the OptiCross 40 MHz Coronary 
Imaging Catheter (K123621, cleared April 15, 2013). The changes to the design are 
limited to the absence of the distal guide catheter tip beyond the ultrasound transducer 
and the absence of the hydrophilic coating applied to the shaft of the OptiCross device 
 
The distal guide catheter tip is not necessary for the pulmonary procedure, as a guidewire 
is not required or used for access, and its presence would limit the depth to which the 
Ultrasound Catheter could access the tracheobronchial tree. The resulting open distal end 
does allow flushing saline to empty faster, leading to more frequent replenishment of the 
flushing saline via the attached 3 cc syringe. The maximum amount of saline expected to 
enter the airway during the procedure (3 mL) is well below that anticipated to be left 
behind in the course of a bronchoalveolar lavage (BAL) procedure (30 mL or more), 
which is recognized as safe.11 The hydrophilic coating is not required, as it is intended to 
enhance the pushability of the device during direct tracking through tortuous anatomy. 
Both the distal guide catheter tip and the hydrophilic coating are applied during the 
manufacturing process, and their absence does not alter the remaining materials of the 
device. 
 
The Catheter body comprises a proximal telescoping shaft and a distal shaft. The 
proximal telescoping shaft and distal shaft compose the usable length of the catheter (135 
cm). The proximal telescoping shaft remains outside of the Catheter. The distal shaft 
serves as a flexible and acoustically transparent imaging window. The proximal 
telescoping shaft provides pushability to the distal imaging window and serves as a 
lumen to the imaging core. The telescope assembly allows the imaging core to be 

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advanced and retracted. The corresponding movement of the transducer occurs from the 
distal end of the catheter body to the proximal end of the imaging window. 
 
The imaging core consists of a proximal hub assembly and a rotating drive cable that 
houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly 
(1) provides an electro-mechanical interface between the catheter and the motor drive 
unit and (2) incorporates a one-way check valve that is used to flush the interior of the 
catheter body. The catheter must be flushed with saline prior to use, as this provides the 
acoustic coupling media required for ultrasonic imaging. 
 
The drive cable and PZT transducer rotate independently of the sheath assembly to 
provide 360° image resolution. The transducer converts electrical impulses sent by the 
motor drive in to transmittable acoustic energy. Reflected ultrasound signals are 
converted back to electrical impulses, returned to the motor drive unit, and are ultimately 
processed by the iNod Ultrasound Imaging System for visualization. 
 
2.3. iNod Ultrasound Imaging System 
 
The iNod Ultrasound Imaging System consists of two compact PC units (one for Image 
Processing and one for Data Acquisition), a control panel, and a monitor, installed on a 
cart. The Data Acquisition PC (front-end PC) contains a PCI-based acquisition board that 
digitizes the RF Ultrasound echo, performs front-end digital signal processing, and direct 
memory accesses ultrasound frames in vector-based format onto the PCI bus. Once data 
is saved into host memory, the vector-based frame of data is packetized and sent over a 
private Local Area Network (LAN) connection onto the Image Processing PC (back-end 
PC) subsystem. 
 
The Image Processing PC unit represents the back-end image-processing engine. The 
real-time vector data retrieved from the Data Acquisition PC is unpacked, temporal 
filtering is executed to reduce transient matters in the frame, and the frame data is 
converted from vector-based to raster-based frame, which can then be displayed on the 
monitor. 
 
While the real-time frames are being processed and displayed, the host processor of the 
Image Processing PC streams raw acquired data and system information onto the system 
hard drive. This stored raw data may later be converted to DICOM format to be exported 
to external media such as CD-Rs, DVD+Rs, removable hard disk cartridge, and DICOM 
network server. 
 
Acquisition, image processing, display, and storage are managed via a graphical user 
interface-based (GUI) Control panel touch screen, all the same as the iLab Ultrasound 
Imaging System. The USB-based Control panel touch screen presents a series of 
software-controlled screens that manage the current imaging case in a structured 
workflow. The system interfaces with the iNod Motor Drive Unit (MDU), the iNod Sled, 
and the iNod Ultrasound Catheter. Accessories of the imaging system are as follow: 

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iNod MDU: The iNod Motor Drive Unit is a non-sterile accessory used with the iNod 
Ultrasound Imaging System. The iNod Motor Drive Unit (MDU) is identical to the 
commercially available MDU5 PLUS for the iLab Ultrasound Imaging System. The 
MDU provides the electro-mechanics for the rotating parts of the iNod Ultrasound 
Catheter, and the interface between the Catheter and the main console. 
 
iNod Sled: The iNod Sled is a non-sterile accessory used with the iNod Ultrasound 
Imaging System. The iNod Sled is identical to the commercially available Permanent 
Sled for the iLab Ultrasound Imaging System. The iNod Sled consists of a cup that 
holds the iNod Motor Drive Unit (MDU). The sled cup can be freely moved manually 
in a proximal or distal direction over a 10cm travel distance. When the MDU is 
placed in to the sled cup, the motordrive engages with the sled drive cone. The 
motordrive can control the movement of the sled cup, but this functionality is not 
intended to be used in the clinical investigation. 
 
2.4. Medical Equipment Description 
 
In addition to the iNod System, all pulmonary endoscopy, or surgical suites where the 
study procedure is being performed must also be equipped with: 
• 2.0 mm working channel bronchial scope model numbers Olympus BF-P190 
or Olympus BF-MP160F 
• Fluoroscopy 
• All equipment necessary for Radial EBUS-guided biopsy of peripheral 
pulmonary lesions. 
• Cytological Rapid On-Site Evaluation (ROSE) 
All research centers are also required to have on-site capabilities for Chest X-Ray. 
 
3. Objectives 
 
To demonstrate feasibility to access, visualize, and obtain specimens adequate for cytology 
of lung lesions in subjects with suspected lung cancer when using the iNod System. 
 
4. Endpoints 
Primary Endpoint: 
Clinical success is defined as the iNod System’s ability to acquire adequate specimens of 
cellular matter suitable for the cytologic evaluation of targeted lung lesions, under real-time 
visualization. 
Salvage Procedure: In case of primary endpoint failure with the iNod System, Radial EBUS 
-guided diagnostic sampling maneuvers (current standard-of-care) will be performed in an 
attempt to access, visualize, and sample targeted lung lesions. 
Secondary Endpoints: 

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1) Occurrence and severity of Adverse Events related to the iNod System biopsy 
procedures, as well as Adverse Events related to any subsequent Radial EBUS-guided 
salvage procedures. 
2) Proportion of lesions visualized during iNod Maneuvers 
3) Proportion of lesions accessed where iNod Biopsy Needles were deployed during study 
maneuvers 
4) Proportion of iNod maneuvers that acquire specimens of cellular matter for cytology 
 
5. Design, Scale, and Duration 
 
This study is a multi-center, prospective, single-arm human feasibility assessment. 
Treatment of 15-30 subjects will take place at 2-3 clinical centers. No single clinical center 
will enroll in excess of 10 subjects. As the iNod System is being evaluated as a diagnostic 
system, study subjects are expected to be consented no more than 2 weeks prior to or up to 
and including the day of, but prior to, their diagnostic procedure. Subjects will exit the study, 
post-procedure following a pre-discharge x-ray. In the case of occurrence of a procedure- 
related Adverse Event, the subject will be followed through event resolution. 
 
6. Subject Selection 
 
6.1 Inclusion Criteria 
 
Subjects who meet all of the following criteria (see Table 6.1-1) may be given 
consideration for inclusion in this clinical investigation, provided no exclusion criterion 
(see Section 6.2) is met. 
Table 6.1-1: Inclusion Criteria 
1) Subject is age 18 years or older. 
2) Subject is willing and able to comply with study procedures and provide 
written informed consent to participate in study. 
3) Subject with a predominantly solid lung lesion, 1 cm to 7 cm in diameter, 
which has been identified on chest CT (obtained within 6 weeks) with the 
intention to undergo a clinically indicated bronchoscopic evaluation under 
routine clinical care. If the lesion is partially solid (i.e. there is a ground 
glass component) then the solid portion must make up 80% of the lesion. 
4) Subject for whom the decision to pursue biopsy has been made by the 
treating physician and agreed upon by the subject. 
Clinical 
Inclusion 
Criteria 

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6.2.Exclusion Criteria 
 
Subjects who meet any one of the following criteria (Table 6.2-1) will be excluded from 
this clinical study. 
Table 6.2-1: Exclusion Criteria 
 
7. Subject Accountability 
 
7.1. Point of Enrollment 
 
Point of enrollment is the time at which, following recruitment, a subject signs and dates 
the informed consent form. 
 
7.2. Withdrawal 
 
All subjects enrolled in the clinical study (including those withdrawn from the clinical 
study or lost to follow-up) shall be accounted for and documented. If a subject withdraws 
from the clinical investigation, the reason(s) shall be reported. If such withdrawal is due 
to problems related to investigational device safety or performance, the investigator shall 
ask for the subject’s permission to follow his/her status/condition outside of the clinical 
study. 
Reasons for withdrawal include physician discretion, subject choice to withdraw consent, 
loss to follow-up and death. Subjects may withdraw from the study at any time, with or 
without reason, and without prejudice to further treatment. All applicable case report 
forms up to the point of subject withdrawal must be completed. Additional data may no 
longer be collected after the point at which a subject has been withdrawn from the study 
or withdraws his/her consent, for whatever reason. All open adverse events should be 
1) Subjects with pure ground glass opacity, a subsolid target lesion, and/or a 
ground glass opacity identified on Chest CT. 
2) Subjects with lesions that include endobronchial involvement, per Chest 
CT. 
3) Subjects who lack fitness to undergo flexible bronchoscopy and standard 
of care Radial EBUS-guided cytological assessment evaluations, as 
determined by the investigator. 
4) Subjects with known coagulopathy. 
5) Subjects who are pregnant or nursing mothers. 
6) Subjects who are currently enrolled in another investigational study that 
would directly interfere with the current study, without prior written 
approval from the sponsor. 
Clinical 
Exclusion 
Criteria 

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closed or documented as chronic. Data collected up to the point of subject withdrawal 
may be used. 
Subjects withdrawn prior to undergoing the diagnostic procedure with the iNod System 
will not count toward a center’s 10 subject limit. 
 
7.3. Enrollment Controls 
 
The risk of over-enrollment is minimized by utilizing a limited number of clinical centers 
and maintaining close communication with study centers. 
8. Study Methods 
 
8.1. Data Collection 

 
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Table 8.1-1: Data Collection Schedule 
Procedure/Assessment 
Study-Specific (iNod) 
or 
Standard of Care (SOC) 
Screening 
Baseline 
Procedure 
Completion / 
Study Exit 
Informed consent form, including informed consent signature 
date 
iNod 
X 
Demographics, including date of birth, and gender 
iNod 
X 
Physical Exam 
iNod 
HCG Pregnancy Testing for women of childbearing potential 
iNod 
X 
Historic Diagnostic Chest CT 
Confirmed at enrollment, but per standard of care within 6 
weeks of procedure 
SOC 
X 
Historic PET Results 
SOC 
O 
Medical history 
iNod 
X 
Sedation 
SOC 
X 
iNod System Diagnostic Procedure(s) 
iNod 
X 
iNod Ultrasound (US) Images including lesion visualization and 
needle visualized in the iNod US Field 
iNod 
X 
Fluoroscopic Images during iNod Maneuver(s) 
iNod 
O 
ROSE (Rapid on-site Evaluation) of obtained specimen (s) 
SOC 
X 
Complete Cytology of obtained specimen(s) 
SOC 
X 
X 
Standard of Care Diagnostic Procedures (as indicated as 
required) 
SOC 
O 
Standard of Care US Images including lesion visualization and 
needle visualized in the iNod US Field 
SOC 
X 
Fluoroscopic Images during Standard of Care Maneuver(s) 
SOC 
O 
ROSE (Rapid on-site Evaluation) of obtained specimen (s) 
SOC 
X 
Complete Cytology of obtained specimen(s) 
SOC 
X 
X 
Discharge X-ray 
SOC 
X 
Device, Procedure, and Anesthesia-related adverse events 
assessment, including Day-7 Post-Procedure Call 
iNod 
X 
X 
 
 
 
 
 
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8.2. Study Candidate Screening 
 
Potential study candidates will be selected based on the investigator’s review of subject 
referrals for evaluation of their medical history and assessment of candidate’s Chest CT, 
completed within 6 weeks of study procedure, that indicate the presence of a suspected 
solid peripheral pulmonary nodule between 1cm and 7cm in size. 
Only subjects that meet the CT and all other Inclusion Criteria should move forward to 
the Informed Consent process. All subjects screened and consented will be patients of the 
investigator(s). 
 
8.3. Informed Consent 
 
Written Informed Consent must be obtained for all subjects who are potential study 
candidates. Subjects will be asked to sign the Informed Consent form before any study- 
specific tests or procedures are performed. The Informed Consent form is study-specific 
and must be approved by the study Institutional Review Board (IRB)/Ethics Committee 
(EC) and Competent Authority, as applicable. 
 
8.4. Baseline 
 
Must be conducted no more than 2 weeks before or on the day of (preceding) iNod 
System procedure. 
• 
Informed Consent 
• 
Eligibility Criteria Assessment 
• 
Demographics 
• 
Bronchoscopy History 
• 
Physical Exam including Height & Weight 
• 
Confirmation of a peripheral pulmonary lesion, per historic Chest CT (within 6 
weeks of precdure) 
 
Baseline attributes of the target lesion will be recorded: 
• 
Location of Lesion 
• 
Size of Lesion 
• 
Attributes of Lesion (e.g. solid or partial ground glass) 
8.5. iNod Diagnostic Procedure 
 
The subject will be prepared for the study procedure under sedation as per current 
standard or care. 
The investigator will perform a bronchoscopic assessment of all lobes of the lung and 
confirm that there are no contraindications to continue with the iNod System procedure. 

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iNod System components are supplied to the investigative centers for the conduct of this 
clinical study by Boston Scientific, free of charge. Each iNod System component will be 
utilized only to the extent and use limits, defined in the Investigator Brochure. Multiple (a 
minimum of 4) iNod Ultrasound Catheters and (a minimum of 4) iNod Biopsy Needles 
are to be available at the commencement of a study procedure. 
All iNod System components utilized during a procedure will be recorded, by serial 
number, to insure device accountability. The model number(s) of the bronchoscope(s) 
being utilized will also be captured. 
The following procedural data will be captured: 
• Timing of the total duration of the case, from initial introduction of the bronchoscope 
to final removal of bronchoscope 
• Each iNod Maneuver will be timed from introduction of the iNod Biopsy Needle 
catheter, pre-loaded with the iNod Ultrasound Catheter, through the removal of the 
iNod Biopsy Needle. 
• Intra-procedural Attributes of the target lesion(s) will be recorded: 
o Location of target lesion (e.g., RB1, RB2, RB3, etc.) 
o Assessment of concentric lesion vs. eccentric lesion 
o Assessment for positive bronchus sign 
 
Imaging to be captured during the iNod System maneuvers, as identified with the serial 
number of the iNod Imaging System and iNod Biopsy Needle being utilized for each 
maneuver, will be collected as follows: 
 
• Ultrasound image of the target lesion 
• Ultrasound image of the deployed iNod Biopsy Needle at the target lesion 
• Supplemental fluoroscopic images, if collected, should also be retained and similarly 
associated to the specific maneuver by documenting the serial number of the iNod 
Biopsy Needle being used for that specific procedure 
 
Rapid on-site evaluation (ROSE) will be completed for all obtained specimens. Results 
will be associated with the serial number of the iNod Biopsy Needle being used for each 
unique specimen. ROSE interpretations, “adequate (for cytologic evaluation)” or 
“inadequate (for cytologic evaluation),” will be recorded. Collected specimens will 
undergo cytologic evaluation following the iNod procedure and final cytologic results 
will be reported in the study database. 

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The following situations would indicate the need to abandon the iNod System Procedure 
and proceed to salvage: 
• If the iNod System is unable to physically reach the lesion, as evidenced by the 
absence of an ultrasound image of the lesion with the iNod System. 
• If 3 separate aspirated specimens obtained from the target lesion with the iNod 
System result in “inadequate (for cytologic evaluation),” the investigator should stop 
iNod maneuvers and proceed to salvage. 
 
8.6. Salvage Procedure 
 
For study subjects for whom an adequate specimen, defined as a specimen that has been 
confirmed as suitable for cytologic evaluation, is not obtained from the iNod System 
diagnostic procedure but for whom continuation with endobronchial maneuvers are not 
contraindicated, additional standard of care (SOC) R-EBUS-guided diagnostic sampling 
maneuvers should be conducted. 
SOC R-EBUS-guided sampling maneuvers may be conducted utilizing various clinically 
standard sampling techniques, including but not limited to fine-needle aspiration, 
brushings, or forceps. Similar to the iNod System procedure, accountability of all SOC 
devices utilized, timing, ultrasound image(s) of target lesion, fluoroscopic images of 
lesions and sampling device, as available, ROSE, and Final Cytology should be captured. 
 
8.7. Study Completion 
 
Post-procedure, subjects will be followed through their discharge chest x-ray following 
their iNod System procedure. 
Verbal contact is to be made with the the subject by a member of the site study team 7 
(+/- 1) days post-procedure. The purpose of this call is for the study team to assess for 
any late-occurring study procedure-related or study device-related safety events. 
 
8.8. Source Documents 
 
Where copies of the original source document as well as printouts of original electronic 
source documents are retained, these shall be signed and dated by a member of the 
investigation center team with a statement that it is a true reproduction of the original 
source document. 
Table 8.8-1: Source Documentation Requirements 
 
Requirement 
Disposition 
Historic Chest CT Report 
Scanned de-identified file for upload in eCRF 
Evidence of Medical History that all Inclusionary 
and Exclusionary elements were confirmed at 
Remain on-site 

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Table 8.8-1: Source Documentation Requirements 
 
Requirement 
Disposition 
Baseline. 
Procedure Records 
Remain on-site 
Procedure Worksheets inclusive of devices used 
per maneuver (by lot or serial number) and timing 
of each maneuver, both for iNod System and 
Standard of Care (as indicated) maneuvers 
Remain on-site 
Cytology Report(s) 
• 
Rapid on-Site Evaluation (ROSE) results 
of each maneuver from which a 
specimen was obtained. Specimens must 
be documented & associated with the 
specific maneuver/specific device from 
which they were obtained. 
• 
Final Cytology Report(s) 
Scanned de-identified file for upload in eCRF 
Operative Note(s) 
Remain on-site 
Discharge X-Ray Report 
Scanned de-identified file for upload in eCRF 
Procedure-related SAE Discharge Summaries 
Scanned de-identified file for fax or email 
transmission the BSC Safety Trial Manager 
Abbreviations: 
 
9. Statistical Considerations 
 
9.1. Endpoints 
 
9.1.1. 
Primary Endpoint 
 
Clinical success is defined as the iNod System’s ability to acquire adequate 
specimens of cellular matter suitable for the cytologic evaluation of targeted lung 
lesions, under real-time visualization. The rate of Clinical Success will be calculated 
as the number of peripheral pulmonary lesions for which adequate cytologic 
specimens suitable for cytologic evaluation were obtained divided by the number of 
lesions the iNod System was attempted. 
 
Hypotheses 
There will be no formal statistical hypothesis tested since this is an observational 
study documenting the first human use of the iNod System 
 
Sample Size 
Enrollment is capped at 30 subjects with a maximum of 10 subjects per center. Since 
no formal hypothesis will be tested, there is no statistical justification of sample size. 

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Peripheral pulmonary lesions vary in their location in the tracheobronchial tree. Their 
size, characteristics (e.g., concentric vs. eccentric), and a sample size of 5-10 subjects 
per site allows greater potential to evaluate the usability and performance of the 
system for visualization and sampling this range of lesions. 
Performance feedback for this traditional feasibility study is sought from more than 1 
physician. While staying within the sample size confines of a traditional feasibility 
study, Boston Scientific has elected to seek the expertise of 2 to 3 interventional 
bronchoscopists. 
 
Statistical Methods 
Since no formal hypothesis is tested, only descriptive statistics will be used to 
summarize the primary endpoint. 
 
9.2. General Statistical Methods 
9.2.1. Analysis Sets 
Intent-to-Treat Cohort 
The intent-to-treat (ITT) cohort consists of subjects enrolled in the study regardless of 
whether a specimen was obtained from the iNod System. 
 
Per Protocol Cohort 
The per-protocol (PP) cohort is a subset of the ITT subjects for whom a specimen was 
obtained using the iNod System. 
 
9.2.2. Control of Systematic Error/Bias 
 
All subjects who have met the inclusion/exclusion criteria and have signed the ICF 
will be eligible for enrollment in the study. Visual and/or electronic data review will 
be performed to identify possible data discrepancies. Manual and/or automatic 
queries will be created in the EDC system and will be issued to the site for 
appropriate response. Site staff will be responsible for resolving all queries in the 
database 
 
9.2.3. Number of Subjects per Investigative Site 
 
A maximum of 10 subjects can be enrolled at each investigative site. 
 
9.3. Data Analyses 
 
Descriptive statistics will be presented for all ITT and PP subjects. The mean (± standard 
deviation) will be used to describe continuous variables with a normal distribution and 
the median (and interquartile range) will be used to describe continuous variables with a 

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skewed distribution. Frequency tables will be used to summarize discrete variables. 
Proportions of subjects with adverse events and SAEs will be reported. 
 
9.3.1. Interim Analyses 
 
No formal interim analyses are planned for the purpose of stopping this study early. 
Informal interim analysis may be conducted for the purpose of submissions of 
abstracts to major professional meetings. 
 
9.3.2. Subgroup Analyses 
 
There are no planned subgroup analyses.] 
 
9.3.3. Justification of Pooling 
 
The analyses will be presented using data pooled across centers as well as by center 
for the primary endpoint. If deemed appropriate, stratified and multivariate analysis 
techniques, including Chi-square test or logistic regression will be used to assess 
differences between study centers to justify pooling data across centers. 
 
9.3.4. Changes to Planned Analyses 
 
Any changes to the planned statistical analyses will be documented in an amended 
Statistical Analysis Plan approved prior to performing the analysis. Changes from the 
planned statistical methods after performing the analysis will be documented in the 
clinical study report along with a reason for the deviation. 
 
10. Data Management 
 
10.1. 
Data Collection, Processing, and Review 
 
Subject data will be recorded in a limited access secure electronic data capture (EDC) 
system. 
The clinical database will reside on a production server hosted by Medidata. All changes 
made to the clinical data will be captured in an electronic audit trail and available for 
review by Boston Scientific Corporation (BSC) or its representative. The associated 
RAVE software and database have been designed to meet regulatory compliance for 
deployment as part of a validated system compliant with laws and regulations applicable 
to the conduct of clinical studies pertaining to the use of electronic records and 
signatures. Database backups are performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on 
printouts of the eCRFs must also be provided if required by local regulation. Changes to 

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data previously submitted to the sponsor require a new electronic signature by the 
Investigator acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the EDC system and 
will be issued to the site for appropriate response. Site staff will be responsible for 
resolving all queries in the database. 
 
10.2. 
Data Retention 
 
The Investigator or Investigational site will maintain, at the investigative site, in original 
format all essential study documents and source documentation that support the data 
collected on the study subjects in compliance with ICH/GCP guidelines. Documents must 
be retained for at least 2 years after the last approval of a 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 BSC or in compliance with other local regulations. It is BSC’s responsibility to 
inform the Investigator when these documents no longer need to be maintained. 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 and BSC must receive written notification 
of this custodial change. 
11. Amendments 
 
If a protocol revision is necessary which affects the rights, safety or welfare of the subject or 
scientific integrity of the data, an amendment is required. Appropriate approvals (e.g., 
IRB/EC/FDA/CA) of the revised protocol must be obtained prior to implementation. 
12. Deviations 
 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC of any deviation from the investigational plan to protect 
the life or physical well-being of a subject in an emergency, and those deviations which 
affect the scientific integrity of the clinical investigation. Such notice shall be given as soon 
as possible, but no later than 5 working days after the emergency occurred, or per prevailing 
local requirements, if sooner than 5 working days. 
All deviations from the investigational plan, with the reason for the deviation and the date of 
occurrence, must be documented and reported to the sponsor using entry onto the eCRF. 
Sites may also be required to report deviations to the IRB/EC, per local guidelines and 
government regulations. 

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Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including notification, center re-training, or 
discontinuation) will be put into place by the sponsor. 
 
13. Device/Equipment Accountability 
 
The investigational devices/equipment shall be securely maintained, controlled, and used 
only in this clinical study. 
The sponsor shall keep records to document the physical location of all investigational 
devices from shipment of investigational devices to the investigation sites until return or 
disposal. 
Records shall be kept by study personnel to document the physical location and conditions of 
storage of all investigational devices/equipment. 
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the investigational devices/equipment, which shall include 
the following 
• Date of receipt 
• Identification of each investigational device/piece of equipment (batch number or unique 
code) 
• Expiry date, as applicable 
• Date or dates of use 
• Subject identification 
• Date on which the investigational device/piece of equipment was returned/explanted from 
subject, if applicable 
• Date of return of unused, expired, or malfunctioning investigational devices/equipment, if 
applicable. 
Written procedures may be required by national regulations. 
 
14. Compliance 
 
14.1. 
Statement of Compliance 
 
This study will be conducted in accordance with relevant sections of the International 
Standard (ISO) 14155: Clinical Investigation of Medical devices for Human Subjects – 
Good Clinical Practice, the relevant parts of the ICH Guidelines for Good Clinical 
Practices, ethical principles that have their origins in the Declaration of Helsinki, and 
pertinent individual country laws and regulations. The study shall not begin until the 

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required approval/favorable opinion from the IRB/EC and/or regulatory authority has 
been obtained, if appropriate. Any additional requirements imposed by the IRB/EC or 
regulatory authority shall be followed, if appropriate. 
 
14.2. 
Investigator Responsibilities 
 
The Principal Investigator of an investigational center is responsible for ensuring that the 
study is conducted in accordance with the Clinical Study Agreement, the investigational 
plan/protocol, ISO 14155, ethical principles that have their origins in the Declaration of 
Helsinki, any conditions of approval imposed by the reviewing IRB/EC, and prevailing 
local and/or country laws and/or regulations, whichever affords the greater protection to 
the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following. 
• Prior to beginning the study, sign the Clinical Study Agreement and Protocol 
Signature page documenting his/her agreement to conduct the study in accordance 
with the protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the center team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study 
or interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and 
physical well-being of a subject in an emergency; document and explain any 
deviation from the approved protocol that occurred during the course of the clinical 
investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all 
clinical-investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to 
the sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) 
every adverse event and observed device deficiency. 
• Report to BSC, per the protocol requirements, all SAEs and device deficiencies that 
could have led to a SADE. 
• Report to the IRB/EC and regulatory authorities any SAEs and device deficiencies 
that could have led to a SADE, if required by the national regulations or this protocol 
or by the IRB/EC, and supply BSC with any additional requested information related 
to the safety reporting of a particular event. 

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• Maintain the device accountability records and control of the device, ensuring that the 
investigational device is used only by authorized/designated users and in accordance 
with this protocol and instructions/directions for use. 
• Allow the sponsor to perform monitoring and auditing activities, and be accessible to 
the monitor and respond to questions during monitoring visits. 
• Allow and support regulatory authorities and the IRB/EC when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation 
in a clinical study in the case of adverse events, as described in the Informed Consent 
Form (ICF). 
• Inform the subject of the nature and possible cause of any adverse events 
experienced. 
• As applicable, provide the subject with necessary instructions on proper use, 
handling, storage, and return of the investigational device when it is used/operated by 
the subject. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, 
as needed. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together 
with identification and compliance information for concomitant treatment measures 
(contact address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical 
investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained 
and documented during the clinical investigation. 

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• Ensure that maintenance and calibration of the equipment relevant for the assessment 
of the clinical investigation is appropriately performed and documented, where 
applicable. 
 
14.2.1. 
Delegation of Responsibility 
 
When specific tasks are delegated by an investigator, including but not limited to 
conducting the informed consent process, the investigator is responsible for 
providing appropriate training and adequate supervision of those to whom tasks 
are delegated. The investigator is accountable for regulatory violations resulting 
from failure to adequately supervise the conduct of the clinical study. 
 
14.3. 
Institutional Review Board 
 
Prior to gaining Approval-to-Enroll status, the investigational center will provide to the 
sponsor documentation verifying that their IRB/EC is registered or that registration has 
been submitted to the appropriate agency, as applicable according to national/regulatory 
requirements. 
A copy of the written IRB/EC and/or competent authority approval of the protocol (or 
permission to conduct the study) and Informed Consent Form, must be received by the 
sponsor before recruitment of subjects into the study and shipment of investigational 
product/equipment. Prior approval must also be obtained for other materials related to 
subject recruitment or which will be provided to the subject. 
Annual IRB/EC approval and renewals will be obtained throughout the duration of the 
study as required by local/country or IRB/EC requirements. Copies of the Investigator’s 
reports and the IRB/EC continuance of approval must be provided to the sponsor. 
 
14.4. 
Sponsor Responsibilities 
 
All information and data sent to BSC concerning subjects or their participation in this 
study will be considered confidential by BSC. Only authorized BSC personnel or a BSC 
representative including Contract Research Organization (CRO) will have access to these 
confidential records. Authorized regulatory personnel have the right to inspect and copy 
all records pertinent to this study. Study data collected during this study may be used by 
BSC for the purposes of this study, publication, and to support future research and/or 
other business purposes. All data used in the analysis and reporting of this study will be 
without identifiable reference to specific subject name. 
Boston Scientific will keep subjects’ health information confidential in accordance with 
all applicable laws and regulations. Boston Scientific may use subjects’ health 
information to conduct this research, as well as for additional purposes, such as 
overseeing and improving the performance of its device, new medical research and 
proposals for developing new medical products or procedures, and other business 
purposes. Information received during the study will not be used to market to subjects; 

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subject names will not be placed on any mailing lists or sold to anyone for marketing 
purposes. 
 
14.4.1. Role of Boston Scientific Representatives 
 
Boston Scientific personnel can provide technical support to the investigator 
and other health care personnel (collectively HCP) as needed during the iNod 
System procedure required by the protocol. Support may include HCP 
training, addressing HCP questions, or providing clarifications to HCPs 
concerning the operation of BSC equipment/devices. 
In addition, BSC personnel may perform certain activities to ensure study 
quality. These activities may include the following. 
• 
Observing testing or medical procedures to provide information relevant 
to protocol compliance 
• 
Reviewing collected data and study documentation for completeness and 
accuracy 
Boston Scientific personnel will not do the following. 
• 
Practice medicine 
• 
Provide medical diagnosis or treatment to subjects 
• 
Discuss a subject’s condition or treatment with a subject without the 
approval and presence of the HCP 
• 
Independently collect critical study data (defined as primary or secondary 
endpoint data) 
• 
Enter data in electronic data capture systems or on paper case report 
forms 
 
14.5. 
Insurance 
 
Where required by local/country regulation, proof and type of insurance coverage, by 
BSC for subjects in the study will be obtained. 
 
15. Monitoring 
 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the monitor verifies that study records are 
adequately maintained, that data are reported in a satisfactory manner with respect to 
timeliness, adequacy, and accuracy, and that the Investigator continues to have sufficient 
staff and facilities to conduct the study safely and effectively. The Investigator/institution 
guarantees direct access to original source documents by BSC personnel, their designees, and 
appropriate regulatory authorities. 

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The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Investigator and 
relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 
 
16. Potential Risks and Benefits 
 
16.1. 
Anticipated Device-related & Procedure-related Adverse Events 
 
The following anticipated adverse events (AE) have been identified with the diagnostic 
procedure that is being studied. Anticipated Adverse Events related specifically to the device 
(iNod System) as well as similar standard of care procedural devices are identified with an 
asterisk (*). 
 
• Allergic Reaction to Medication 
• Aspiration 
• Bleeding* 
• Bronchospasm 
• Cardiac Arrhythmia or Arrest 
• Cough 
• Dyspnea 
• Fever 
• Infection 
• Hemomediastinum* 
• Hemorrhage* 
• Hypotension 
• Infection* 
• Inflammation* 
• Laceration* 
• Laryngospasm 
• Nausea 
• Nerve Damage 
• Over sedation leading to: 
o Hypercapnia 
o Hypoxemia 
o Hypotension 
• Pain 
• Perforation* 
• Post-Procedural Chest Pain 
• Post-Procedural Hiccup 
• Pneumonia 
• Pneumoperitoneum* 

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• Pneumothorax * 
• Pneumomediastinum* 
• Respiratory Depression or Arrest 
• Tissue Damage* 
• Tumor Seeding 
• Transient Lowered Oxygen 
• Vomiting 
 
16.2. 
Risks Associated with the Study Device(s) 
 
No incremental risks are associated with the study device that are above those of market 
available products. 
 
16.3. 
Risks associated with Participation in the Clinical Study 
 
Participation in the trial may result in a prolonged procedure when compared to standard 
of care sampling of peripheral pulmonarylesions. 
Pariticipation in the trial may result in an unintended breach of the subject’s 
confidentiality. 
 
16.4. 
Risk Minimization Actions 
 
Additional risks may exist. Risks can be minimized through compliance with this 
protocol, performing procedures in the appropriate hospital environment, adherence to 
subject selection criteria, close monitoring of the subject's physiologic status during 
research procedures and/or follow-ups and by promptly supplying BSC with all pertinent 
information required by this protocol. 
 
16.5. 
Anticipated Benefits 
 
Subjects may not receive any benefit from being in this study. However, medical science 
and future subjects may benefit from this study. 
 
16.6. 
Risk to Benefit Rationale 
 
Based on collected reports in literature to-date, the risk-to-benefit ratio is within reason 
for foreseeable risks. However, literature reports do not always capture all side effects. 
Observation and follow-up of subjects is required as outlined in the protocol. 

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17. Safety Reporting 
 
17.1. 
Reportable Events by Investigational Site to Boston Scientific 
 
It is the responsibility of the investigator to assess and report to BSC any event which 
occurs in any of following categories: 
• All Serious Adverse Events 
• All Study Device, Study Procedure, and Study Procedure Anesthesia-related Adverse 
Events 
• All Investigational Device Deficiencies 
• Unanticipated Adverse Device Effects 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event 
cannot be isolated from the device, procedure, or anesthesia, it should be submitted as an 
adverse event and/or device deficiency. 
Any AE event required by the protocol, experienced by the study subject after informed 
consent and once considered enrolled in the study (as defined in study subject 
classification section), whether during or subsequent to the procedure, must be recorded 
in the eCRF. 
Underlying diseases are not reported as AEs unless there is an increase in severity of 
frequency during the course of the investigation. Death should not be recorded as an AE, 
but should only be reflected as an outcome of one (1) specific SAE (see Table 17.2-1 for 
AE definitions). 
Refer to Section 16 for the known risks associated with the study device(s). 
Adverse event definitions are provided in Table 17.1-1. Administrative edits were made 
to combine definitions from ISO 14155-2011 and MEDDEV 2.7/3 12/2010. 
 
Table 17.1-1: Safety Reporting Definitions 
 
Term 
Definition 
Adverse Event (AE) 
Ref: ISO 14155-2011 
Ref: MEDDEV 2.7/3 12/2010 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, whether or not related to the investigational 
medical device. 
NOTE 1: This includes events related to the investigational medical device 
or comparator. 
NOTE 2: This definition includes events related to the procedures involved 
(any procedure in the clinical investigation plan). 

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Table 17.1-1: Safety Reporting Definitions 
 
Term 
Definition 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the investigational medical device. 
Adverse Device Effect (ADE) 
Ref: ISO 14155-2011 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event related to the use of an investigational medical device 
NOTE 1: This definition includes any adverse event resulting from 
insufficient or inadequate instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
investigational medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the investigational medical device. 
Serious Adverse Event (SAE) 
Ref: ISO 14155-2011 
Ref: MEDDEV 2.7/3 12/2010 
Adverse event that: 
• Led to death, 
• Led to serious deterioration in the health of the subject, that either 
resulted in: 
o a life-threatening illness or injury, or 
o a permanent impairment of a body structure or a body function, or 
o in-patient or prolonged hospitalization of existing hospitalization, or 
o medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function 
• Led to fetal distress, fetal death, or a congenital abnormality or birth 
defect. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without serious 
deterioration in health, is not considered a serious adverse event. 
Serious Adverse Device Effect 
(SADE) 
Ref: ISO 14155-2011 
Ref: MEDDEV 2.7/3 12/2010 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
Unanticipated Adverse Device 
Effect (UADE) 
Ref: 21 CFR Part 812 
Note: For US IDE studies only, 
otherwise remove UADE from 
table 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree 
of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or welfare 
of subjects. 
Device Deficiency 
Ref: ISO 14155-2011 
Ref: MEDDEV 2.7/3 12/2010 
A device deficiency is any inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
NOTE 1: Device deficiencies include malfunctions, misuse or use errors, 
and inadequate labeling. 

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Table 17.1-1: Safety Reporting Definitions 
 
Term 
Definition 
Abbreviations: EC=Ethics Committee; IRB=Institutional Review Board 
 
Underlying diseases are not reported as AEs unless there is an increase in severity or 
frequency during the course of the investigation. Death should not be recorded as an AE, 
but should only be reflected as an outcome of a specific SAE (see Table 17.1-1 for AE 
definitions). 
Any related AE experienced by the study subject after informed consent, whether during 
or subsequent to the procedure, must be recorded in the eCRF. 
Refer to Section 16 for the known risks associated with the study device(s). 
 
17.2. 
Relationship to Study Device(s) 
 
The Investigator must assess the relationship of the AE to the study device, study 
procedure, or study procedure anesthesia as related or not related. See criteria in Table 
17.2-1: 
 
 
Table 17.2-1: Criteria for Assessing Relationship of Study Device, Study Procedure, & 
Study Procedure Anesthesia to Adverse Event 
 
Classification 
Description 
Not Related 
The adverse event is determined to be due to a concurrent illness or effect of another 
device/drug and is not related to the investigational product. 
Related 
• The adverse event is determined to be potentially related to the investigational 
product, and an alternative etiology is equally or less likely compared to the 
potential relationship to investigational product, or 
• There is a strong relationship to investigational product, or recurs on re-challenge, 
and another etiology is unlikely, or 
• There is no other reasonable medical explanation for the event. 
 
17.3. 
Investigator Reporting Requirements 
 
The communication requirements for reporting to BSC are as shown in Table 17.3-1. 
Table 17.3-1: Investigator Reporting Requirements 
 
Event Classification 
Communication Method 
Communication Timeline 
Unanticipated Adverse Device 
Effect 
Complete AE eCRF page with all 
available new and updated information. 
• Within 1 business day of first 
becoming aware of the event. 
• Terminating at the end of the 
study 

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Table 17.3-1: Investigator Reporting Requirements 
 
Event Classification 
Communication Method 
Communication Timeline 
Serious Adverse Event 
including Serious Adverse 
Device Effects 
Complete AE eCRF page with all 
available new and updated information. 
• Within 2 business days of first 
becoming aware of the event or 
as per local/regional regulations. 
• Reporting required through the 
end of the study 
Provide all relevant source 
documentation (unidentified) for 
reported event 
• When documentation is 
available 
Device Deficiencies (including 
but not limited to failures, 
malfunctions, and product 
nonconformities) 
Note: Any Investigational 
Device Deficiency that might 
have led to a serious adverse 
event if a) suitable action had 
not been taken or b) 
intervention had not been 
made or c) if circumstances 
had been less fortunate is 
considered a reportable event. 
Complete Device Event Form 
• Within 2 business days of first 
becoming aware of the event and 
as per local/regional regulations. 
• Reporting required through the 
end of the study 
Adverse Event 
Complete AE eCRF page, which 
contains such information as date of 
AE, treatment of AE resolution, 
assessment of seriousness and 
relationship to the device. 
• In a timely manner (e.g. 
Recommend within 10 business 
days) after becoming aware of 
the information 
• Reporting required through the 
end of the study 
Abbreviations: AE=adverse event; CRF=case report form; IDE=Investigational Device Exemption; 
UADE=unanticipated adverse device effect 
 
 
17.4. 
Boston Scientific Device Deficiencies 
 
All device deficiencies (including but not limited to failures, malfunctions, use errors, 
product nonconformities, and labeling errors) will be documented and reported to BSC. If 
possible, the device(s) should be returned to BSC for analysis. Instructions for returning 
the investigational device(s) will be provided. If it is not possible to return the device, the 
investigator should document why the device was not returned and the final disposition 
of the device. Device failures and malfunctions should also be documented in the 
subject’s medical record. 
Device deficiencies (including but not limited to failures, malfunctions, and product 
nonconformities) are to be reported as Device Events and are not to be reported as 

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adverse events. However, if there is an adverse event that results from a device failure or 
malfunction, that specific event would be recorded on the Adverse Event eCRF. 
Any Investigational Device Deficiency that might have led to a serious adverse event if a) 
suitable action had not been taken or b) intervention had not been made or c) if 
circumstances had been less fortunate is considered a reportable event. 
 
17.5. 
Reporting to Regulatory Authorities / IRBs / ECs / Investigators 
 
BSC is responsible for reporting adverse event information to all participating 
investigators and regulatory authorities, as applicable. 
The Principal Investigator is responsible for informing the IRB/EC, and regulatory 
authorities of UADE and SAE as required by local/regional regulations. 
 
18. Informed Consent 
 
Subject participation in this clinical study is voluntary. Informed Consent is required from all 
subjects or their legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any investigational devices, 
study-required procedures and/or testing, or data collection. 
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority body, as applicable. The ICF must be 
approved by BSC or it’s delegate (e.g. CRO), the center’s IRB/EC, or central IRB, if 
applicable. 
Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative center’s IRB/EC. Any modification requires approval from BSC prior to use of 
the form. The ICF must be in a language understandable to the subject and if needed, BSC 
will assist the center in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC approval prior to their use. Privacy language shall be included in the 
body of the form or as a separate form as applicable. 
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process, 
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 

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• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study. 
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the center and a copy of the signed and dated document and 
any other written information must be given to the person signing the form. 
Failure to obtain subject consent will be reported by BSC to the applicable regulatory body 
according to their requirements (e.g., FDA requirement is within 5 working days of learning 
of such an event). Any violations of the informed consent process must be reported as 
deviations to the sponsor and local regulatory authorities (e.g. IRB/EC), as appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC. The new version of the ICF must be approved by 
the IRB/EC. Boston Scientific approval is required if changes to the revised ICF are 
requested by the center’s IRB/EC. The IRB/EC will determine the subject population to be 
re-consented. 
 
19. Safety Monitoring Process 
 
To promote early detection of safety issues, the BSC Medical Monitor will provide 
evaluations of safety events. Success of this program requires dynamic collection of 
unmonitored data as soon as the event is reported. This is expedited through BSC’s Global 
Safety Office, which is responsible for coordinating the collection of information for the 
subject dossier from the centers and core laboratories. During regularly scheduled monitoring 
visits, clinical research monitors will support the dynamic reporting process through their 
review of source document information. 

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20. Suspension or Termination 
 
20.1. Premature Termination of the Study 
 
Boston Scientific Corporation reserves the right to terminate the study at any stage but 
intends to exercise this right only for valid scientific or administrative reasons and 
reasons related to protection of subjects. Investigators, associated IRBs/ECs, and 
regulatory authorities, as applicable, will be notified in writing in the event of study 
termination. 
 
20.1.1. Criteria for Premature Termination of the Study 
 
Possible reasons for premature study termination include, but are not limited to, the 
following. 
o The occurrence of unanticipated adverse device effects that present a 
significant or unreasonable risk to subjects enrolled in the study. 
o An enrollment rate far below expectation that prejudices the conclusion of the 
study. 
o A decision on the part of Boston Scientific to suspend or discontinue 
development of the device. 
 
20.2. Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
Approval 
 
Any investigator or IRB in the iNod Feasibility Study may discontinue participation in 
the study or withdrawal approval of the study, respectively, with suitable written notice to 
Boston Scientific. Investigators, associated IRBs, and regulatory authorities, as 
applicable, will be notified in writing in the event of these occurrences. 
 
20.3 
Requirements for Documentation and Subject Follow-up 
 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating centers by Boston 
Scientific. The IRB/EC and regulatory authorities, as applicable, will be notified. 
Detailed information on how enrolled subjects will be managed thereafter will be 
provided. 
In the event an IRB terminates participation in the study, participating investigators, 
associated IRBs/ECs, and regulatory authorities, as applicable, will be notified in writing. 
Detailed information on how enrolled subjects will be managed thereafter will be 
provided by Boston Scientific. 
In the event an investigator terminates participation in the study, study responsibility will 
be transferred to a co-investigator, if possible. In the event there are no opportunities to 

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transfer investigator responsibility; detailed information on how enrolled subjects will be 
managed thereafter will be provided by Boston Scientific. 
The investigator must return all documents and investigational product to Boston 
Scientific, unless this action would jeopardize the rights, safety, or welfare of the 
subjects. 
 
20.4 
Criteria for Suspending/Terminating a Study Center 
 
Boston Scientific Corporation reserves the right to stop the inclusion of subjects at a 
study center at any time after the study initiation visit if no subjects have been enrolled 
for a period beyond 3months after center initiation, or if the center has multiple or severe 
protocol violations/noncompliance without justification and/or fails to follow remedial 
actions. 
In the event of termination of investigator participation, all study devices and testing 
equipment, as applicable, will be returned to BSC unless this action would jeopardize the 
rights, safety or well-being of the subjects. The IRB/EC and regulatory authorities, as 
applicable, will be notified. All subjects enrolled in the study at the center will continue 
to be followed through resolution of any procedure-related adverse events unled they are 
considered to endure in a chronic nature. The Principal Investigator at the center must 
make provision for these follow-up visits unless BSC notifies the investigational center 
otherwise. 
 
21. Publication Policy 
 
In accordance with the Corporate Policy on the Conduct of Human Subject Research, BSC 
requires disclosure of its involvement as a sponsor or financial supporter in any publication 
or presentation relating to a BSC study or its results. In accordance with the Corporate Policy 
for the Conduct of Human Subject Research, BSC will submit study results for publication 
(regardless of study outcome) following the conclusion or termination of the study. Boston 
Scientific Corporation adheres to the Contributorship Criteria set forth in the Uniform 
Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed. 
1. All authorship and contributorship requirements as described above must be 
followed. 
2. BSC involvement in the publication preparation and the BSC Publication Policy 
should be discussed with the Coordinating Principal Investigator(s) and/or 
Executive/Steering Committee at the onset of the project. 

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3. The First and Senior authors are the primary drivers of decisions regarding 
publication content, review, approval, and submission. 
 
22. Bibliography 
 
 
1. 
World Health Organization. International Agency for Research on Cancer. 
GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevelence 
Worldiwde in 2012. Lung Cancer. Accessed November 10, 2014. 
2. 
Centers for Disease Control and Prevention. National Center for Health Statistics. 
CDC WONDER On-line database, compiled from compressed Mortaility File 1999- 
2012 Series 20 No. 2R, 2014. 
3. 
U.S. Nation Institues of Health. National Cancer Institute. SEER Cnacer Statistics 
Review, 1975-2011. 
4. 
Gould MK, Donington J, Lynch WR, et al. Evaluation of individuals with pulmonary 
nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: 
American College of Chest Physicians evidence-based clinical practice guidelines. 
Chest 2013; 143:e93S-120S. 
5. 
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. 
6. 
Wahidi MM, Govert JA, Goudar RK, et al. Evidence for the treatment of patients 
with pulmonary nodules: when is it lung cancer?: ACCP evidence-based clinical 
practice guidelines (2nd edition). Chest 2007; 132:94S-107S. 
7. 
Gaeta M, Pandolfo I, Volta S, et al. Bronchus sign on CT in peripheral carcinoma of 
the lung: value in predicting results of transbronchial biopsy. AJR Am J Roentgenol 
1991; 157:1181-1185. 
8. 
Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: 
Diagnosis and management of lung cancer, 3rd ed: American College of Chest 
Physicians evidence-based clinical practice guidelines. Chest 2013; 143:e142S-165S. 
9. 
Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJF. Comparison of suction 
catheter versus forceps biopsy for sampling of solitary pulmonary nodules guided by 
electromagnetic navigational bronchoscopy. Respiration 2010;79(1):54-60. 
10. 
Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for 
the evaluation of the pulmonary nodule. Chest 2012;142(2):385-393. 
11. 
Goldstein RA, et al. Clinical role of bronchoalveolar lavage in adults with pulmonary 
disease. Am Rev Respir Dis. 1990 Aug;142(2):481-6. 

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23. Abbreviations and Definitions 
23.1 Abbreviations 
Abbreviations are shown in table 23.1-1. 
 
 
Table 23.1-1: Abbreviations 
Acronym 
Definition 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
CT 
Computed Tomography 
CXR 
Chest X-Ray 
DFU 
Directions for Use 
EBB 
Endobronchial Biopsy 
EBUS 
Endobronchial Ultrasound 
eCRF 
Electronic Case Report Form 
EC 
Ethics Committe 
EDC 
Electronic Data Capture 
FB 
Flexible Bronchoscopy 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practices 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IRB 
Institutonal Review Board 
ISO 
ITT 
International Standards Organization 
Intent-to-Treat 
MDU 
Motor Drive Unit 
PP 
Per-Protocol 
PZT 
Piezoelectric Transducer 
R-EBUS 
Radial Endobronchial Ultrasound 
ROSE 
Rapid On-Site Evaluation 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
TBLB 
Transbronchial Lung Biopsy 
TBNA 
Transbronchial Needle Aspiration 
TTNA 
Transthoracic Needle Aspiration 
VATS 
Video-Assisted Thorascopic Surgery 
VB 
Virtual Bronchoscopy 

Confidential 
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23.2. 
Definitions 
 
Terms are defined in Table 23.2-1. 
Table 23.2-1: Definitions 
Term 
Definition 
 
 
SOURCE DATA 
All information in original records and certified copies of original records of 
clinical finding, observations, or other activities in a clinical trial necessary for 
the reconstruction and evaluation of the trial. Source data are contained in the 
source documents (original records or certified copies). 
SOURCE DOCUMENTS 
Original documents, data, and records. 
Abbreviations are defined in Table 23.1-1.