NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for Electromagnetic Navigation Bronchoscopy™
Conditions: Lung Lesion(s) Requiring Evaluation
Sponsor: Medtronic - MITG

Surgical Innovations 
Lung Health 
161 Cheshire Lane 
Suite 100 
Plymouth, MN 55441 
USA 
www.medtronic.com 
 
 
Document Cover Page 
 
 
Study:  NAVIGATE 
 
Official Title: NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for 
Electromagnetic Navigation Bronchoscopy  
 
ClinicalTrials.gov ID:  NCT02410837 
 
Document Type:  Study Protocol that includes Statistical Analysis Plan 
 
Date of Document :  17-NOV-2015 (version 2.1) 
 
 
 
 

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1.0 Title Page 
Clinical Investigational Plan (CIP) INFORMATION 
Title: 
NAVIGATE: Clinical Evaluation of superDimension™ Navigation System for 
Electromagnetic Navigation Bronchoscopy 
CIP Number: 
COVENBP0475 
Version Date: 
November 17, 2015 
Version: 
2.1 
Sponsor 
Representatives: 
 
 
 
Medtronic 
15 Hampshire Street 
Mansfield, MA 02048 USA 
 
  
 
This investigational plan contains confidential information for use by investigators participating in the 
Medtronic Clinical Evaluation of the superDimension™ Navigation System for Electromagnetic 
Navigation Bronchoscopy study (NAVIGATE). It should be maintained in a secure location.  It should not 
be copied or made available for review by any unauthorized person or firm. 
 
Summary of Changes to CIP 
Version 
Section 
Description of Change 
Reason for Change 
1 
N/A 
N/A 
N/A 
1.1 (EU 
only) 
9.2 
Removed the example statement on 
Investigator eligibility for roll-in subjects 
example of conducting less than 5 ENB 
procedures in last 30 days. 
Clarification on eligibility for roll-in 
subjects. Final determination of 
eligibility for roll-in cases will be 
assessed during the qualification process. 
At this time, Version 1.1 is for Europe 
only. 
2.0 
4.0, 8.2.2, 
8.6.4.3, 
8.6.5  
Added ENB Productivity and Activity 
Questionnaire (ENB-PAQ) to the 1-month 
visit. 
It is beneficial to obtain a subject’s 
assessment of how the ENB procedure 
affects their work productivity and 
activities. 
2.0 
4.0, 8.2.2 
Added “other lung disease” to the 
secondary diagnosis endpoints. 
The study has the ability to capture and 
report on this information. 
2.0 
4.0, 5.2, 
8.2.2 
Clarified the secondary endpoint on 
adequacy for molecular testing. 
The purpose of the endpoint surrounded 
the adequacy of sample collection, rather 
than the testing itself. 

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2.0 
4.0,8.4.2 
Removed the portion of the exclusion 
criteria on the pregnancy test. 
Females who are pregnant or nursing 
should not participate in the study, but 
sponsor will leave it up to the 
institutional policies/standard of care if 
they will require pregnancy tests. 
2.0 
5.2, 8.4, 
11.0 
Procedure time changed from 
bronchoscope in/out to locatable guide 
in/out. 
This change adequately captures the 
actual procedure of ENB, and leaves out 
other procedures that could occur at the 
same visit. 
2.0 
8.3 
Changed the requirement of an 
investigator to be medically licensed 
rather than board certified. 
Board certification language was part of 
the template CIP.  For purposes of this 
study, having a Medical License is 
sufficient. 
2.0 
8.6.4.1, 
8.6.5 
Moved smoking history into the medical 
history assessment.  Clarified what 
medical histories would be collected. 
Since smoking history is part of a 
medical history, and other aspects of a 
medical history are to be collected, 
clarification on medical history was 
made. 
2.0 
8.6.4.3 
Removed the requirement of the 1-month 
visit to be conducted in person, and added 
the allowance of 1-month visits to be 
conducted via phone. 
A 1-month post procedure visit is not 
typically standard of care for most sites.  
This is affecting enrollment and subject 
returns for 1-month visit.  All 1-month 
visit data can be easily collected via 
phone. 
2.0 
9.3 
Lowered the maximum enrollment per site 
from 250 to 75. 
This was to help the study to collect data 
at a wide range of different sites.  Certain 
regions may decide to have a lower cap 
for their region. 
2.0 
n/a 
Minor updates (such as contact 
information) and minor clarifications were 
made throughout the protocol.  These 
minor changes did not affect the purpose 
or requirements of the study. 
Minor updates and clarifications were 
needed in the protocol to meet global 
regulatory requirements or to provide 
contact updates or to make minor 
corrections.  
2.1 
4.0, 8.2.2, 
8.6.4.3, 
8.6.5 
Changed the name of the added 
questionnaire “Electromagnetic 
Navigation Bronchoscopy Productivity 
and Activity Questionnaire (ENB-PAQ)” 
Name change required. 
 
 
 

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2.0 Principal Investigator Signature Page 
 
Principal Investigator Signature Page 
Title: 
NAVIGATE: Clinical Evaluation of superDimension™ Navigation 
System for Electromagnetic Navigation Bronchoscopy 
CIP Number: 
COVENBP0475 
Version Date: 
November 17, 2015 
Version: 
2.1 
 
I, the undersigned, have read and understood the protocol specified above and agree on its 
content. I agree to perform and conduct the study as described in the protocol and in accordance 
with the relevant laws/regulations and standards outlined in the Clinical Investigation 
Agreement. 
 
 
 
 
 
 
 
Name 
 
Signature 
 
Date 
 
 
 
 

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3.0 Table of Contents 
 
1.0 
Title Page ........................................................................................................................................................ 1 
2.0 
Principal Investigator Signature Page ............................................................................................................. 3 
3.0 
Table of Contents ............................................................................................................................................ 4 
4.0 
Protocol Synopsis ............................................................................................................................................ 6 
5.0 
Acronyms and Definitions ............................................................................................................................... 9 
5.1 
Acronyms ..................................................................................................................................................... 9 
5.2 
Definitions .................................................................................................................................................. 10 
6.0 
Introduction ................................................................................................................................................... 12 
6.1 
Background/Justification of Investigation .................................................................................................. 12 
6.2 
Report of Prior Investigations .................................................................................................................... 13 
6.2.1 
Biocompatibility Evaluation .............................................................................................................. 13 
6.2.2 
Clinical Studies.................................................................................................................................. 13 
7.0 
Identification and Description of Device....................................................................................................... 15 
7.1 
Device Description ..................................................................................................................................... 15 
7.2 
Indication and Contraindications ............................................................................................................... 16 
7.3 
Identification .............................................................................................................................................. 16 
8.0 
Study Design ................................................................................................................................................. 16 
8.1 
Study Objective .......................................................................................................................................... 17 
8.2 
Endpoints ................................................................................................................................................... 17 
8.2.1 
Primary Endpoint .............................................................................................................................. 17 
8.2.2 
Secondary Endpoints ......................................................................................................................... 17 
8.3 
Selection of Investigational Centers and Training Requirements .............................................................. 18 
8.4 
Subject Selection and Enrollment .............................................................................................................. 19 
8.4.1 
Inclusion Criteria ............................................................................................................................... 19 
8.4.2 
Exclusion Criteria .............................................................................................................................. 19 
8.5 
Withdrawal of Subjects .............................................................................................................................. 19 
8.6 
Study Procedures ........................................................................................................................................ 20 
8.6.1 
Screening and Informed Consent ...................................................................................................... 20 
8.6.2 
Screen Failures .................................................................................................................................. 20 
8.6.3 
ENB Procedures ................................................................................................................................ 20 
8.6.4 
Study Schedule .................................................................................................................................. 21 
8.6.5 
Study Assessments Table .................................................................................................................. 22 
9.0 
Statistical Analysis ........................................................................................................................................ 22 
9.1 
General ....................................................................................................................................................... 23 
9.2 
Roll-in Subjects .......................................................................................................................................... 23 
9.3 
Sample Size Determination ........................................................................................................................ 23 
9.4 
Analysis of Baseline Demographics and Procedural Characteristics ......................................................... 24 
9.5 
Endpoint Analysis ...................................................................................................................................... 24 
9.6 
Handling of Missing Data .......................................................................................................................... 24 
9.7 
Analysis Populations .................................................................................................................................. 24 
9.8 
Interim Analysis ......................................................................................................................................... 25 
9.9 
Pre-planned Subgroup Analysis ................................................................................................................. 25 
10.0 
Risk/Benefit Analysis .................................................................................................................................... 25 
10.1 
Risks of ENB ......................................................................................................................................... 25 
11.0 
Adverse Events & Complications ................................................................................................................. 26 
11.1 
Adverse Event (AE) ............................................................................................................................... 26 
11.2 
Serious Adverse Event (SAE) ................................................................................................................ 26 
11.3 
Unanticipated Adverse Device Effect (UADE) ..................................................................................... 27 
11.4 
Adverse Event Relationship Classification ............................................................................................ 27 
11.5 
Adverse Event Outcome Classification ................................................................................................. 27 
11.6 
Adverse Event Recording ...................................................................................................................... 27 
11.7 
Adverse Event Reporting ....................................................................................................................... 28 
12.0 
Device Deficiencies ....................................................................................................................................... 29 

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12.1 
Medical Monitor .................................................................................................................................... 29 
13.0 
Ethics and Compliance .................................................................................................................................. 29 
13.1 
Statement of Compliance ....................................................................................................................... 29 
13.2 
Protocol Compliance.............................................................................................................................. 29 
13.3 
Confidentiality ....................................................................................................................................... 30 
13.4 
Data Access and Publications ................................................................................................................ 30 
13.5 
Role of the Steering Committee ............................................................................................................. 31 
14.0 
Monitoring Procedures .................................................................................................................................. 31 
14.1 
Data Collection and Processing ............................................................................................................. 32 
15.0 
Study Supplies and Device Accountability ................................................................................................... 32 
16.0 
General Information ...................................................................................................................................... 32 
16.1 
Study Contact Information ..................................................................................................................... 32 
16.2 
Retention of Records ............................................................................................................................. 33 
16.3 
Study Completion/Termination of Study ............................................................................................... 33 
17.0 
References ..................................................................................................................................................... 33 
18.0 
Appendices .................................................................................................................................................... 37 
18.1 
Sample Patient Informed Consent ......................................................................................................... 37 
18.2 
Lung Cancer Staging ............................................................................................................................. 37 
 
 
 

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4.0 Protocol Synopsis 
Background and Rationale of the Study 
Study Objective 
The objective of this prospective, single-arm, multicenter, post-
market, observational, study is to evaluate outcomes following 
electromagnetic navigation bronchoscopy (ENB) procedures using 
the superDimension™ navigation system. 
Test Device  
superDimension™ Navigation System 
Control or 
Comparator 
Not applicable 
Study Design 
Study Type 
Prospective, single-arm, multicenter, post-market, observational  
Study Phase 
Post-market 
Study Location 
Global 
Planned Follow-Up 
All subjects will be followed for 24 months 
Planned # of Subjects 
Up to 2,500 globally 
Planned # of Sites 
Up to 75 
Primary Endpoint 
The primary endpoint is the incidence of pneumothorax related to 
the ENB index procedure rated as Grade 2 or higher according to 
the Common Terminology Criteria for Adverse Events (CTCAE) 
scale. 
Secondary Endpoints 
The following secondary endpoints will be evaluated for all ENB 
index procedures: 
1. Incidence of all pneumothorax related to ENB index 
procedure 
2. Incidence of bronchopulmonary hemorrhage related to ENB 
index procedure rated as Grade 2 or higher according to 

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CTCAE scale 
3. Incidence of respiratory failure related to ENB index 
procedure rated as Grade 4 or higher according to CTCAE 
scale 
4. Subject health status evaluated by EQ-5D questionnaire at 
all visits 
5. Subject satisfaction evaluation at 1-month visit 
6. ENB procedure effect on subject productivity and activity 
using the ENB Productivity and Activity Questionnaire 
(ENB-PAQ) at 1-month visit 
The following secondary endpoints will be evaluated for all ENB 
index procedures performed for suspicion of cancer or other lung 
diseases in a lung lesion: 
7. Diagnostic yield 
8. Sensitivity 
9. Specificity 
10. Positive predictive value (PPV)  
11. Negative predictive value (NPV) 
12. Repeat biopsy rate due to lack of diagnosis during ENB 
index procedure 
13. Adequacy of sample for molecular testing and mutation type 
(if applicable) 
14. Diagnosis 
15. Stage at diagnosis (if applicable) 
The following secondary endpoint will be evaluated for all ENB 
index procedures conducted for placement of fiducial markers: 
16. Success rate of accurate placement of fiducial markers 
demonstrated through follow-up imaging. 
The following secondary endpoint will be evaluated for all ENB 
index procedures conducted for dye marking in preparation for 
surgical resection. 
17. Success rate of dye marking demonstrated by successful 
surgical resection 
The following secondary endpoint will be evaluated for all ENB 
index procedures conducted for a lymph node biopsy: 
18. Success rate of obtaining lymph node biopsy to provide 
stage of diagnosis. 

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Randomization 
Not applicable 
Follow-Up Schedule 
Subjects will be evaluated at baseline, procedure, 1 month, 12 
months, and 24 months post-index ENB procedure. 
Eligibility Criteria 
Inclusion Criteria 
1. Subject presents with lung lesion(s) requiring evaluation  
2. Subject is willing and able to provide informed consent to 
participate in the study 
3. Subject is candidate for elective ENB procedure 
4. Subject is over the age of 18  
Exclusion Criteria 
1. The subject is unable or unwilling to comply with study 
follow-up schedule 
2. The subject has participated in an investigational drug or 
device research study within 30 days of enrollment that 
would interfere with this study 
3. Female subjects who are pregnant or nursing as determined 
by standard site practices 
Statistics 
Endpoint Analyses 
Study data will be summarized as descriptive statistics (counts and 
percentages). 
Determination of 
Sample Size 
No formal sample size estimates were conducted. The study is 
predefined to include up to 2,500 subjects. 
Interim Analyses 
Interim analyses will be conducted as defined in the publication 
plan. All interim analyses will be based on complete data for the 
specified follow-up timepoint.  
Pre-Planned 
Subgroup Analysis 
Subgroup analysis of the study endpoints on multiple subsets of 
study subjects based upon variables such as geography, 
demographics, investigator experience, and lesion and procedure 
characteristics are planned.   
 

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5.0 Acronyms and Definitions 
5.1 
Acronyms 
eCRF 
electronic case report form 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
EC 
ethics committee 
ENB 
electromagnetic navigation bronchoscopy 
EP 
existing patient 
GCP 
good clinical practice 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IFU 
instructions for use 
IRB 
institutional review board 
NCI 
National Cancer Institute 
NP 
new patient 
NPBI 
New patient, brief interaction (<6 visits and no inpatient hospitalization) 
NPCC 
New patient, continued care 
NPV 
negative predictive value 
PAQ 
Productivity and Activity Questionnaire 
PPV 
positive predictive value 
RDC 
remote data capture 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
TNM 
Revised International System for Staging Lung Cancer Classification System  
TTNA 
transthoracic needle aspiration 

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5.2 
Definitions 
Bronchopulmonary hemorrhage 
A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma. Degree of 
severity will be classified according to Common Terminology Criteria for Adverse Events 
(CTCAE) grade as follows: 
• Grade 1: Mild symptoms; intervention not indicated 
• Grade 2: Moderate symptoms; medical intervention indicated 
• Grade 3: Transfusion, radiologic, endoscopic, or operative intervention indicated (e.g., 
hemostasis of bleeding site) 
• Grade 4: Life-threatening respiratory or hemodynamic compromise; intubation or urgent 
intervention indicated 
• Grade 5: Death 
Common Terminology Criteria for Adverse Events 
A set of criteria for the standardized classification of adverse effects of drugs used in cancer 
therapy. The CTCAE system is a product of the US National Cancer Institute (NCI) 
Diagnostic Test Evaluations 
• Diagnostic Yield: the proportion of cases that yield a definitive diagnosis. Diagnostic 
yield will be calculated per patient (as the denominator) and not per the number of lesions 
biopsied if multiple lesions were biopsied in a single ENB procedure. 
• Where a=true positive, b=false positive, c=false negative, and d=true negative: 
o Sensitivity: Probability that an ENB-guided biopsy will be positive when 
malignancy is present (true positive rate):  = a / (a+c) 
o Specificity: Probability that an ENB-guided biopsy will be negative when 
malignancy is not present (true negative rate):  = d / (b+d) 
o Positive predictive value (PPV):  Probability that malignancy is present when an 
ENB-guided biopsy is positive:  = a / (a+b) 
o Negative predictive value (NPV):  Probability that malignancy is not present 
when an ENB-guided biopsy is negative:  = d  / (c+d) 
Existing Patient (EP) 
Defined as subjects under care by treating institution more than 30 days prior to the ENB index 
procedure 
Lesion Size 
Defined as greatest diameter of target lesion 

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Navigation Accuracy 
Distance between tip of the locatable guide and the targeted lung lesion (not done for lymph 
nodes) 
Navigation Success 
The proportion of cases in which the operator is able to successfully navigate to the lung target 
with ENB guidance 
Navigation Time 
Total time that locatable guide is used in the subject during the ENB procedure  
New Patient (NP) 
Defined as subjects new to treating institution within 30 days of the ENB procedure and referred 
by physicians not affiliated with treating institution 
NPs will be further categorized as: 
• Those with a brief interaction (BI) with treating institution (<6 visits and no inpatient 
hospitalization):  NPBI 
• Those who undergo continued care at treating institution:  NPCC 
Peripheral Lung Lesion 
A lesion that is located in the outer third of the lung and difficult to reach by traditional 
bronchoscopy 
Pneumothorax 
A disorder characterized by abnormal presence of air in the pleural cavity resulting in the 
collapse of the lung. Degree of severity will be classified according to CTCAE grade as follows: 
• Grade 1: Asymptomatic; clinical or diagnostic observations only; intervention not 
indicated 
• Grade 2: Symptomatic; intervention indicated (e.g., tube placement without sclerosis) 
• Grade 3: Sclerosis and/or operative intervention indicated; hospitalization indicated 
• Grade 4: Life-threatening consequences; urgent intervention indicated 
• Grade 5: Death 
Procedure Time 
Time between initial introduction of the Locatable Guide into the body and final removal of the 
Locatable Guide 
Repeat biopsy rate due to lack of diagnosis during ENB index procedure  
Additional biopsy or biopsies conducted after the ENB-guided index procedure, required due to 
insufficient tissue collection for diagnosis at the index procedure. 

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Respiratory Failure 
A disorder characterized by impaired gas exchange by the respiratory system resulting in  
hypoxemia and a decrease in oxygenation of the tissues that may be associated with an increase 
in arterial levels of carbon dioxide. Degree of severity will be classified according to CTCAE 
grade as follows: 
• Grade 4: Life-threatening consequences; urgent intervention, intubation, or ventilatory 
support indicated 
• Grade 5: Death 
Stage 
Lung cancer staging will be defined according to the Revised International System for Staging 
Lung Cancer (TNM) Classification System (1, 2). Refer to Appendix 17.2, NAVIGATE_Lung 
Cancer Staging. 
Tissue Adequacy   
Tissue adequacy is defined as the proportion of cases in which tissue obtained during the ENB 
index procedure is adequate for subtyping of lung cancer and molecular testing when appropriate 
6.0 Introduction 
6.1 
Background/Justification of Investigation 
Rapid and precise diagnosis of suspicious lesions is crucial to determine the optimal treatment 
for lung disease. Diagnosis of peripheral lung lesions, which comprise 25-30% of all lung 
lesions, is particularly challenging (3, 4). 
Technologies that allow for earlier diagnosis and treatment of malignant lung disease are crucial 
for improving survival rates. According to the American Cancer Society’s 2014 estimates, the 
survival rate for distant (metastasized) lung cancer is 4%, compared to 26% for regional cancer 
and 54% for localized cancer (5). 
Electromagnetic navigation bronchoscopy (ENB)™ is an image-guided approach that uses 3D-
reconstructed computed tomography (CT)-scan and sensor location technology to guide a 
steerable endoscopic probe to peripheral lung lesions that may be beyond the reach of 
conventional bronchoscopes (5-7).  
Over 24 original research articles have been published describing outcomes following ENB to 
aid in the diagnosis of peripheral lung lesions and mediastinal lymph nodes (3, 6-28). Diagnostic 
yield aided by ENB in these studies has ranged from 59.0% to 94.0%, with rates generally higher 
in more recent analyses (3, 6, 9, 10, 15, 17, 18, 20, 23-25).  
ENB is also associated with a more favorable safety profile than alternative techniques; in a 
meta-analysis of 15 studies representing data from over 1000 lung nodules, the pneumothorax 

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rate after ENB was only 3.1% (29). In comparison, in a meta-analysis of 19 studies, the median 
pneumothorax incidence rate following CT-guided transthoracic biopsy was 25% (range 4% to 
60%) (30). 
Despite these promising results, outcomes following ENB are widely varied and most evidence 
to date is based on single-center analyses (21 of the 24 published studies) with only 3 studies 
enrolling greater than 100 subjects (see Table 1). The impact of user/center experience, patient 
risk factors, and lesion characteristics remains largely unexplored in a large multi-center study. 
In addition, further information is needed about the use of ENB to place dye markers to allow 
biopsy and surgery in the same procedure, the use of ENB to place fiducials to enable radiation 
therapy, the adequacy of cells and tissue captured using ENB for genomic testing, the impact of 
ENB on stage of diagnosis, and the cost effectiveness of ENB. 
The proposed post-market study will enroll up to 2,500 consecutive subjects at up to 75 sites 
worldwide, making it the largest prospective ENB clinical study to date. The 24-month follow-
up of this study will also allow an assessment of the correlation between stage of diagnosis and 
long-term survival rates, in contrast to most prior ENB studies that evaluated only diagnostic 
yield and acute complication rates. 
The objective of this prospective, single-arm, multicenter, post-market, observational, study is to 
evaluate outcomes following electromagnetic navigation bronchoscopy (ENB) procedures using 
the superDimension™ navigation system. 
6.2 
Report of Prior Investigations 
6.2.1 Biocompatibility Evaluation 
Biocompatibility testing was performed on all components of the product to demonstrate that the 
materials used are acceptable for the intended use. Biological safety testing has been successfully 
completed for the relevant device components; the devices are compliant with EN ISO 10993-
1:2009 standard and FDA guidelines. 
6.2.2 Clinical Studies 
Results of 24 original research articles describing outcomes following ENB to aid in the 
diagnosis of peripheral lung lesions and mediastinal lymph nodes are summarized below. Based 
on the data in the table, the diagnostic yield weighted mean is 73.6% overall, 69.0% for studies 
published between 2005 and 2010, and 78.5% for studies published between 2011 and 2014. The 
overall pneumothorax weighted mean rate is 3.0%. 

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Table 1. Prior Clinical Studies 
Study Lead Author 
and Citation 
Study Design 
N Pts. 
Diagnostic Yield 
(%) Aided by 
ENB 
Pneumothorax (%) 
Balbo PE (6) 
Retrospective, non-consecutive, 
single-center, single-arm 
40 
70.7 
0.0 
Becker HD (7) 
Prospective, consecutive, single-
center, single-arm 
29 
69.0 
3.4 
Bertoletti L (8) 
Prospective, single-center 
53 
77.4 
4.0 
Brownback KR (9) 
Retrospective, consecutive, single-
center, single-arm 
55 
74.5 
0.0 
Diken ÖE (10) 
Prospective, randomized, single-
center 
94 
72.8 
0.0 
Eberhardt R (11) 
Prospective, multi-center, 
randomized controlled trial 
39 
59.0 
5.0 
Eberhardt R (12) 
Prospective, single-center 
53 
67.0 
2.3 
Eberhardt R (13) 
Prospective, non-consecutive, 
multi-center, single-arm 
89 
75.5 
1.9 
Gildea TR (14) 
Prospective, single-center, pilot 
study 
58 
74.0 
3.5 
Jensen KW (15) 
Retrospective, consecutive, multi-
center, single-arm 
92 
65.0 
3.3 
Karnak D (16) 
Prospective 
21 
85.7 
4.8 
Karnak D (17) 
Prospective, consecutive, single-
center, single-arm 
76 
89.5 
3.9 
Khan AY (18) 
Prospective, single-center, single-
arm 
24 
75.0 
0.0 
Lamprecht B (19) 
Retrospective, consecutive, single-
center, single-arm 
13 
76.9 
0.0 
Lamprecht B (20) 
Prospective, consecutive, single-
center, single-arm 
112 
83.9 
1.8 
Loo FL (3) 
Retrospective, consecutive, single-
center, single-arm 
40 
94.0 
0.0 
Mahajan AK (21) 
Retrospective, single-center, 
single-arm 
48 
77.0 
10.2 
Makris D (22) 
Prospective, consecutive, single-
center, single-arm 
40 
62.5 
7.5 
Mohanasundaram U 
(23) 
Retrospective, single-center, 
single-arm 
41 
89.0 
13.0 
Odronic SI (24) 
Retrospective, consecutive, single-
center, single-arm 
91 
85.7 
5.3 

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Table 1. Prior Clinical Studies 
Study Lead Author 
and Citation 
Study Design 
N Pts. 
Diagnostic Yield 
(%) Aided by 
ENB 
Pneumothorax (%) 
Pearlstein DP (25) 
Retrospective, consecutive, single-
center, single-arm 
101 
85.0 
5.8 
Schwarz Y (26) 
Prospective, controlled, single-
center 
13 
69.2 
0.0 
Seijo LM (27) 
Prospective, consecutive, single-
center, single-arm 
51 
67 
0.0 
Wilson DS (28) 
Retrospective, consecutive, single-
center, single-arm 
248 
69.8 
1.2 
Diagnostic yield defined as the proportion of subjects in whom ENB-directed biopsy yielded a diagnosis, as reported in the original article 
7.0 Identification and Description of Device 
7.1 
Device Description 
The superDimension™ navigation system is an image-guided localization system used to 
navigate endoscopic tools to targets in the lungs, such as lymph nodes and solitary pulmonary 
nodules. The superDimension™ navigation system consists of several reusable (non-sterile) 
hardware components used for ENB. A picture of the main console and a list of system 
components are shown below in Figure 1. 

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Localization system 
System cart 
Isolation transformer 
Location subsystem 
Uninterruptable power supply 
Industrial personal computer 
Touch screen monitor 
Location board 
Patient sensor triplet 
Sensor patches 
Keyboard 
Mouse 
Remote control 
Foot pedal 
 
Currently available guiding catheter and accessory tools 
Locatable guide 
Extended working channel 
Edge locatable guide 
Edge extended working channel 
Edge extended working channel firm tip 
Bronchoscope adaptor 
Bronchoscope clip 
Patient sensors 
Localization components 
Figure 1. superDimension™ Navigation System and Components 
7.2 
Indication and Contraindications 
The System User Manual and the applicable Instructions for Use (IFU) will be the primary 
source of information for the system and components and will be kept current at each site 
throughout the study.   
For detailed information regarding the indicated use of the device and contraindications, please 
refer to the System User Manual and applicable IFU(s). 
7.3 
Identification 
The superDimension™ navigation system available at the clinical site will be used to conduct all 
ENB procedures. The system must have software version 6.0 or higher. 
8.0 Study Design 
Up to 2,500 consecutive subjects who undergo an ENB procedure using the superDimension™ 
navigation system will be enrolled at up to 75 global clinical sites. Consecutive subjects who 

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meet the eligibility criteria, sign informed consent, and undergo an ENB procedure using the 
superDimension™  navigation system will be included in the study. Subjects will be evaluated at 
baseline, procedure, 1 month, 12 months, and 24 months.  
8.1 
Study Objective 
The objective of this prospective, single-arm, multicenter, post-market, observational, study is to 
evaluate outcomes following ENB procedures using the superDimension™ navigation system. 
8.2 
Endpoints 
This post-market study is intended to capture clinical outcomes related to the real world use of 
ENB including but not limited to peripheral lesion biopsies, lymph node biopsies, fiducial 
market placement for radiation therapy, and tumor marking for diagnostic and therapeutic 
surgery.  
The primary endpoint was chosen as a comprehensive safety endpoint that would be applicable 
to all ENB procedures being conducted as part of this study.  The secondary endpoints are a 
combination of both safety and effectiveness endpoints that will be categorized in relation to 
intent of the ENB procedure being conducted.  
8.2.1 Primary Endpoint 
The primary endpoint is the incidence of pneumothorax related to the ENB index procedure rated 
as Grade 2 or higher according to the CTCAE scale. 
8.2.2 Secondary Endpoints 
The following secondary endpoints will evaluated for all ENB index procedures: 
1. Incidence of all pneumothorax related to ENB index procedure 
2. Incidence of bronchopulmonary hemorrhage related to ENB index procedure rated as 
Grade 2 or higher according to CTCAE scale 
3. Incidence of respiratory failure related to ENB index procedure rated as Grade 4 or 
higher according to CTCAE scale 
4. Subject health status evaluated by EQ-5D questionnaire at all visits 
5. Subject satisfaction evaluation at 1-month visit 
6. ENB procedure effect on subject productivity and activity using the ENB Productivity 
and Activity Questionnaire (ENB-PAQ) at 1-month visit 
The following secondary endpoints will be evaluated for all ENB index procedures performed 
for suspicion of cancer or other lung diseases in a lung lesion: 
7. Diagnostic yield 
8. Sensitivity 
9. Specificity 

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10. Positive predictive value (PPV)  
11. Negative predictive value (NPV) 
12. Repeat biopsy rate due to lack of diagnosis during ENB index procedure 
13. Adequacy of sample for molecular testing and mutation type (if applicable) 
14. Diagnosis 
15. Stage at diagnosis (if applicable) 
The following secondary endpoint will be evaluated for all ENB index procedures conducted for 
placement of fiducial markers: 
16. Success rate of accurate placement of fiducial markers demonstrated through follow-up 
imaging. 
The following secondary endpoint will be evaluated for all ENB index procedures conducted for 
dye marking in preparation for surgical resection. 
17. Success rate of dye marking demonstrated by successful surgical resection 
The following secondary endpoint will be evaluated for all ENB index procedures conducted for 
a lymph node biopsy: 
18. Success rate of obtaining lymph node biopsy to provide stage of diagnosis. 
8.3 
Selection of Investigational Centers and Training Requirements 
For this study, the following center selection criteria will be utilized. 
• The center must have superDimension™ navigation system with Version 6 software or 
higher 
• The center must have sufficient patient population, defined as the ability to perform at 
least five (5) ENB procedures per month 
• There are no other ongoing studies that would prevent center from achieving enrollment 
goals 
• The center has adequate research staff to conduct the study 
• The center must be willing and able to comply with the Clinical Investigational Plan and 
data reporting requirements 
• The center must be willing to enroll consecutive eligible subjects 
• The center must have experience and/or ability to utilize the electronic data capture 
system 
• The investigator(s) must be medically licensed 
• The investigator(s) must have completed or be willing to complete the superDimension™ 
navigation system training course conducted by Medtronic 

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Physicians in training (surgical residents, fellows) and Physician Assistants may assist the study 
investigator in the procedure as per standard procedures and practices at his/her institution; 
however, a study investigator must be the primary operator during the ENB procedure.   
Each investigator participating in the clinical trial and the associated clinical study staff will 
receive training on the clinical protocol, as well as the ENB procedure utilizing the 
superDimension™ navigation system. 
Medtronic will maintain a list of sites and investigators who are participating in the study; this 
information will be available on www.clinicaltrials.gov. 
8.4 
Subject Selection and Enrollment 
After being informed of the nature of the study, the subject will sign a written informed consent 
form (ICF) that has been approved by the appropriate Institutional Review Board (IRB) or Ethics 
Committee (EC) of the respective clinical site. Following signing the informed consent form, the 
point of enrollment is defined as the time at which the ENB procedure is started. The start of the 
ENB procedure is defined as time of initial introduction of the Locatable Guide into the body.  
Up to 2,500 subjects will be enrolled in the study at up to 75 sites.  Subjects’ participation in the 
study will last approximately 24 months 
The ENB procedure will be performed per the System User Manual, applicable product IFU and 
the institution’s standard practice.  Subjects will be considered for the study if they meet 
specified inclusion criteria and none of the exclusion criteria.  The criteria for enrollment must be 
followed explicitly.   
8.4.1 Inclusion Criteria 
1. Subject presents with lung lesion(s) requiring evaluation  
2. Subject is willing and able to provide informed consent to participate in the study 
3. Subject is candidate for elective ENB procedure 
4. Subject is over the age of 18  
8.4.2 Exclusion Criteria 
1. The subject is unable or unwilling to comply with study follow-up schedule 
2. The subject has participated in an investigational drug or device research study within 30 
days of enrollment that would interfere with this study 
3. Female subjects who are pregnant or nursing as determined by standard site practices  
8.5 
Withdrawal of Subjects 
The reason for study exit of all enrolled subjects  will be documented on the applicable electronic 
case report form (eCRF).  In the event the subject withdraws consent during the study, the date 
of withdrawal will be documented.  If the study investigator voluntarily removes a subject from 

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further study participation, supporting documentation must be in place for the rationale and date 
of removal.  Every attempt will be made to contact subjects who are noncompliant.  Subjects will 
be considered lost to follow-up once the following steps have been taken: 
• Two phone calls should be made to the subject. Each attempt should be clearly 
documented in the source documents and the response or lack thereof should be captured.   
• If there is no response to the phone calls, then certified letter should be written to the 
subject.  A copy of the letter should be retained in the subject’s source document. 
• After a period of two (2) weeks following completion of the above actions, the subject 
will be considered Lost to Follow-up.  The sponsor should be notified and the Study Exit 
form should be completed.   
8.6 
Study Procedures 
8.6.1 Screening and Informed Consent 
A baseline visit will be performed within 30 days prior to the scheduled procedure to assess 
study eligibility.  Subjects will be approached to obtain written informed consent prior to any 
institution non-standard-of-care assessments or study specific data being collected. The purpose 
of the study and the benefits and risks of participating in the study will be explained to the 
subject and the consent process must be documented accordingly in the medical record.  Subjects 
who agree to study participation must sign an IRB/EC approved ICF.  Subjects will be informed 
that their participation in this study is voluntary and that they may refuse to participate or 
discontinue from the study at any time.  Additionally, subjects will be informed that despite 
signing informed consent, the screening assessments may demonstrate the subject is not a 
suitable candidate for the study and may be withdrawn.  Subjects will be given the opportunity to 
ask the investigator questions so that they are adequately informed about the research.  A copy of 
the signed ICF must be provided to the subject. 
If new information becomes available that may affect a subject’s decision to continue to take 
part in the study, this information will be discussed with the subject. 
8.6.2 Screen Failures 
Subjects who provide study consent, but then are determined to be ineligible prior to the ENB 
procedure will be considered Screen Failures and will not require additional study follow-up 
visits.  The reason for the Screen Failure will be clearly documented on the applicable eCRFs.  
Screen Failures will not be counted towards the number of study subjects. 
8.6.3 ENB Procedures 
The ENB procedure should be conducted in accordance with the System User Manual, 
applicable IFU and local institution standard of care. 

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8.6.4 Study Schedule 
Subjects will be evaluated at baseline, procedure, 1 month, 12 months, and 24 months post-index 
ENB procedure, as detailed below and in Table 2. All study data will be reported on the 
appropriate subject eCRFs.   
8.6.4.1 Baseline 
The following assessments will be performed within 30 days prior to the scheduled ENB 
procedure: 
• Signed informed consent 
• Eligibility criteria 
• Demographics 
• Medical history (including smoking history, lung history, anticoagulant and anti-platelet 
therapy medications, and risk factors)   
• Quality of life questionnaire assessment utilizing EQ-5D 
8.6.4.2 Procedure 
The following procedures and assessments will be performed on the day of the index procedure 
(Day 0): 
• Procedural information 
• Lesion characteristics (if applicable) 
• Biopsy results (if applicable) 
• Adverse event assessment 
• Lung cancer assessment 
• Healthcare utilization 
8.6.4.3 1 Month 
It is preferred that the 1-month visit be conducted as in-person visit; however it will be 
acceptable to obtain the required information through a telephone visit with the subject.  
Additionally, a systematic review of the subject’s medical records should be evaluated to ensure 
that all information is accurately reported. 
The following procedures and assessments will be performed 1 month (±7 days) post-index 
procedure:  
• Adverse event assessment 
• Lung cancer assessment 
• Healthcare utilization 
• Repeat biopsy results (if applicable) 
• Quality of life assessment utilizing EQ-5D 
• Patient satisfaction assessment 

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• Productivity and activity assessment using the ENB-PAQ 
8.6.4.4 12 and 24 Months 
It is preferred that the 12 and 24 month visits be conducted as an in-person visit.  However, it 
will be acceptable to obtain the required information through a telephone visit with the subject.  
Additionally, a systemic review of the subject’s medical records should be evaluated to ensure 
that all information is accurately reported.  
The following procedures and assessments will be performed 12 months (±30 days) and 24 
months (±30 days) post-index procedure: 
• Adverse event assessment 
• Lung cancer assessment 
• Healthcare utilization 
• Repeat biopsy results (if applicable) 
• Quality of life assessment utilizing EQ-5D 
8.6.5 Study Assessments Table 
Table 2: Table of Assessments 
 
Baseline 
(Day -30 to 0) 
Procedure 
(Day 0) 
1 month 
 (±7 days) 
12 months 
 (±30 days) 
24 months 
 (±30 days) 
Informed consent 
X 
 
 
 
 
Eligibility criteria 
X 
 
 
 
 
Demographics 
X 
 
 
 
 
Medical history 
X 
 
 
 
 
Procedural information 
 
X 
 
 
 
Lesion characteristics (if 
applicable) 
 
X 
 
 
 
Adverse event assessment 
 
X 
X 
X 
X 
Lung cancer assessment 
 
X 
X 
X 
X 
Healthcare utilization 
 
X 
X 
X 
X 
Biopsy results (if applicable) 
 
X 
X 
X 
X 
EQ-5D questionnaire 
X 
 
X 
X 
X 
Patient satisfaction assessment 
 
 
X 
 
 
ENB-PAQ 
 
 
X 
 
 
9.0 Statistical Analysis  
A separate statistical analysis plan (SAP) will be maintained to describe statistical methods and 
data analysis procedures. 

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9.1 
General 
All statistical analyses will be performed using Statistical Analysis System (SAS) for Windows 
(version 9.2 or higher, SAS Institute Inc. Cary, NC) or other widely accepted statistical or 
graphical software.  In general, data for all study subjects combined will be presented.  
Individual data will be presented in subject listings. 
Descriptive statistics will be used to present the data and to summarize the results.  Discrete 
variables will be presented using frequency distributions and cross tabulations.  Continuous 
variables will be summarized by presenting the number of observations (N), mean, standard 
deviation, median, minimum, and maximum values. 
In general, data analysis will be conducted on all subjects who are enrolled in the trial and 
undergo an ENB procedure utilizing the superDimension™ navigation system. Analyses will be 
conducted on multiple subsets of study subjects based upon variables such as geography, 
demographics, investigator experience, lesion and procedure characteristics, and other variables 
as deemed appropriate.  Results from interim and final analyses will be presented and/or 
published as defined in the Publication Plan. 
9.2 
Roll-in Subjects 
For participating investigators who meet investigator selection criteria but do not have extensive 
experience conducting ENB procedures utilizing the superDimension™ navigation system, the 
investigator may be allowed to perform “roll-in cases”. A maximum of five (5) roll-in cases will 
be allowed per investigator.  The purpose of the roll-in cases is to provide consistency in the 
physician user base within the study.   
Final determination of eligibility for roll-in cases will be assessed as part of the investigator 
qualification process and will be documented in the study files. 
Roll-in subjects will be considered study participants and will complete all protocol-required 
procedures and exams. However, data for the roll-in population will be analyzed separately from 
the remaining study population in an effort to detect any differences of outcomes related to level 
of investigator experience.   
9.3 
Sample Size Determination 
No formal sample size estimates were conducted. The study is designed to include up to 2,500 
subjects. 
Each site will be allowed to enroll a maximum of 75 subjects into the study.  

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9.4 
Analysis of Baseline Demographics and Procedural Characteristics 
Descriptive statistics will be generated for pre-intervention demographics, procedural 
characteristics, and follow-up data collected.  Categorical variables will be analyzed using 
frequency, incidence, and event rate.  For continuous variables collected in the study, analysis 
will include mean, median, standard deviation, and range. 
9.5 
Endpoint Analysis 
For the primary and secondary endpoints, descriptive statistics will be provided.  The endpoints 
will be summarized using frequency measures such as count and percentage.  For the primary 
endpoint, a 2-sided 95% exact binomial confidence interval will also be provided.   
Adverse events for all enrolled subjects will be collected and reported for each follow-up visit.  
For adverse event reporting, which includes the primary and secondary endpoints, the primary 
analysis will be based on subject counts (e.g., the number and percentage of subjects with event 
among the total number of Subjects).  The data will be presented in the format of p% (x/N) [e], 
with p and x being the percentage and number of subjects with events, respectively, N being the 
sample size of the analysis population, and e being the total number of events occurred in the x 
subjects.  For example, the data of 2% (20/1000) [38] indicates that a total of 38 events occurred 
in 20 subjects out of a total of 1000 subjects (2%).   
9.6 
Handling of Missing Data 
For the primary endpoint, the assessment is done peri-procedurally and it is projected that there 
will be minimal reduction in the eligible population based on the time of the measurement. 
Therefore, no imputations are planned for the primary endpoints.   
9.7 
Analysis Populations 
Clinical data will be assessed in the following subject groups.  Additional groups, such as 
country specific populations, may be assessed as deemed appropriate. 
1. Roll-in cohort:  defined as subjects identified as “roll-in subject” upon study enrollment 
(see Section 9.2). 
2. Primary cohort:  defined as all subjects who are enrolled in the trial and undergo and 
ENB index procedure utilizing the superDimension™ navigation system minus roll-in 
subjects 
3. Overall cohort: defined as all subjects who are enrolled in the trial and undergo and ENB 
procedure utilizing the superDimension™ navigation system 

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9.8 
Interim Analysis 
Interim analyses will be conducted as defined in the publication plan. All interim analyses will 
be based on complete data for the specified follow-up timepoint. All interim analyses must be 
pre-specified and approved by the steering committee.  
At a minimum, the following interim analyses will be conducted:  
1. First 500 primary cohort subjects undergo ENB index procedure and complete the 1-
month follow-up visit 
2. First 1,000 primary cohort subjects undergo ENB index procedure and complete the 1-
month follow-up visit 
3. First 1,500 primary cohort subjects undergo ENB index procedure complete the 1-month 
follow-up visit 
Additional interim analyses may be performed as appropriate.  
9.9 
Pre-planned Subgroup Analysis 
It is planned to evaluate the primary and secondary endpoints on multiple subsets of study 
subjects based upon variables such as geography, demographics, investigator experience, lesion 
and procedure characteristics, and other variables as deemed appropriate.  The subgroup analyses 
are exploratory in nature, for the purpose of evaluating the safety and effectiveness performance 
of the study device under various clinical conditions. 
10.0 
Risk/Benefit Analysis 
All devices utilized in this study are commercially available. There are no anticipated risks 
related to inclusion of subjects in this clinical study above and beyond anticipated risks related to 
any ENB procedure. All records identifying the subject will be kept confidential and, to the 
extent permitted by the applicable laws and/or regulations, will not be made publicly available. 
Subject names will be kept confidential.  Outside of the normal procedure, the study may or may 
not be of benefit to the study subject.  The data collected from this study will help to establish 
new information on the ENB procedure and the diagnosis and treatment of lung lesions. 
10.1 Risks of ENB 
Rex et al. performed a systematic review and a meta-analysis of ENB for the evaluation of 
peripheral lung lesions. A total of 15 studies, representing data from 1,033 lung nodules, were 
included. A total of 32 pneumothoraces were reported (3.1%), of which 17 (1.6%) required chest 
tube drainage.  Nine cases of minor or moderate bleeding were reported, none requiring 
treatment or intervention. Other reported complications were 1 self-limited hematoma event and 
1 episode of hypercapnic respiratory failure attributed to sedation (29).  

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Table 1 in Section 6.2.2 above lists pneumothorax rates in ENB studies published in the Rex 
meta-analysis, with the addition of more recently published ENB studies (24 studies in total).  
The weighted mean pneumothorax rate specifically for ENB procedures based on the data 
provided in Table 1 is 3% (range 0% to 13%). 
11.0 
Adverse Events & Complications 
Adverse events will be collected after the ENB index procedure has been initiated (defined as 
introduction of the Locatable Guide into the subject). During the course of the study, the 
following AEs will be collected and reported on the eCRF: 
• All AEs related to the superDimension™ navigation system, associated tools, or ENB 
procedure (both index and any subsequent repeat ENB procedure) 
• All deaths 
• All pneumothoraxes 
• All bronchopulmonary hemorrhages  
• All respiratory failures 
11.1 Adverse Event (AE) 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not 
related to the investigational medical device.  
NOTE: Documented pre-existing conditions are not considered to be reportable AEs unless there 
is a change in the nature or severity of the condition. 
11.2 Serious Adverse Event (SAE) 
A serious AE (SAE) is an AE that has 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
c) led to fetal distress, fetal death or a congenital abnormality or birth defect 

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NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the study, 
without serious deterioration in health, is not considered a serious AE. 
11.3 Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse device effect (UADE) is an adverse event related to the study device 
which by its nature, incidence, severity or outcome has not been previously identified in product 
risk analysis.  
11.4 Adverse Event Relationship Classification 
Relationship to study product administration will be determined as follows: 
• Not related: No relationship between the AE and the administration of study treatment 
and a known relationship to other etiologies such as concomitant medications, surgical 
procedure or subject’s clinical state. 
• Related: An AE that follows a plausible temporal sequence from administration of the 
study treatment and follows a known response pattern to the study treatment.  The 
reaction cannot be reasonably explained by the known characteristics of the subject’s 
clinical state or other modes of therapy administered to the subject. 
• Impossible to Determine: Given the information available, sequence and timing of 
events, it is impossible to determine the relationship of the AE with the study treatment. 
11.5 Adverse Event Outcome Classification 
Outcome of the event will be defined according to the following:  
• Resolved: The event has fully resolved. 
• Continuing: The event is ongoing. 
11.6  Adverse Event Recording 
Assessment of the occurrence of an AE will be based on changes in the subject’s physical 
examination, laboratory results, and/or signs and symptoms.  AEs will be monitored until a 
subject completes the study. Any unresolved procedural or device related events that are still 
ongoing past study exit will be monitored by the physician per their institutional standard of care.  
AEs will be documented in the applicable source documentation and reported on an AE eCRF. 
To the extent possible, the event to be recorded and reported is the event diagnosis as opposed to 
event symptoms (e.g., fever, chills, nausea and vomiting in the presence of a clinically diagnosed 
infection is to be reported as infection only). 
For purposes of this protocol, the following occurrences are considered to be expected 
observations following bronchoscopy procedures (primarily associated with anesthesia) and will 

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not be considered AEs, as long as the event is not associated with significant sequelae, does not 
prolong hospitalization, and responds to standard medical therapy:  
• Post procedure transient nausea determined to be procedure related and resolving within 
4 days after the procedure  
• Post procedure transient emesis determined to be procedure related and resolving within 
3 days after the procedure  
• Post procedure constipation, determined to be procedure and/or medication related 
• Post procedure pain that the study investigator considers common and expected post 
procedure 
All responses to the above events that require treatment beyond the institution’s standard 
procedures will be reported as AEs. 
11.7 Adverse Event Reporting 
Please refer to Table 3 for a list of the minimum AE reporting requirements for investigators. If 
local regulations or IRB/EC require faster reporting, then the investigator will adhere to those 
requirements.  
Table 3: Investigator AE Reporting Requirements 
Type 
Report to 
Reporting Timeframe (from time of learning of the event) 
Adverse Event 
Sponsor 
Recommended within 10 working days 
IRB/EC 
Per IRB/EC reporting requirements 
Serious Adverse 
Event 
Sponsor 
Recommended within 24 hours, required within 10 working days 
IRB/EC 
Per IRB/EC reporting requirements 
Unanticipated 
Adverse Device 
Effect 
Sponsor 
Recommended within 24 hours, required within 10 working days 
IRB 
Required within 10 working days 
EC 
Per EC reporting requirements 
Events will be reviewed by Medtronic or designee to determine any reporting obligations to FDA 
or Competent Authorities as well IRB/EC.  Reporting will occur within the timelines per local 
regulations and requirements. 

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12.0 
Device Deficiencies 
A device deficiency is an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety or performance, such as malfunction, misuse or use error and 
inadequate labeling. 
All superDimension™ navigation system (including associated accessories and tools) device 
deficiencies will be documented on the appropriate eCRF and the device should be returned to 
Covidien for analysis, if possible.  Instructions for returning the device will be provided.  Device 
deficiencies should also be documented in the subject’s medical record. 
Device deficiencies are NOT to be reported as AEs.  However, if there is an AE that results from 
a device deficiency, that specific event would be recorded on the appropriate eCRF. 
12.1 Medical Monitor 
The Sponsor will utilize a Medtronic Medical Monitor to provide a medical review and 
adjudication of pre-specified AEs in support of protocol defined endpoint data. The Medical 
Monitor will be a qualified, board-certified physician that is not affiliated with an investigative 
center.  
During the review of AEs, the Medical Monitor will be not be blinded to the treatment and 
investigational site. 
13.0 
Ethics and Compliance 
13.1 Statement of Compliance 
This clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki, International Conference on Harmonisation Good 
Clinical Practice guideline (ICH GCP), and any regional or national regulations, as appropriate.  
All principles of the Declaration of Helsinki have been implemented in this clinical study by 
means of the patient informed consent process, IRB/EC approval, clinical study training, clinical 
study registration, publication policy, etc. 
The clinical investigation will not begin until all necessary approvals/favorable opinions are 
obtained from the appropriate IRB/EC or regulatory authority, as appropriate.  Should an 
IRB/EC or regulatory authority impose any additional requirements, they will be followed. 
13.2 Protocol Compliance 
No changes to the protocol will be permitted without the written approval from Medtronic and 
the IRB/EC.  The investigator must notify Medtronic and the reviewing IRB/EC of any deviation 
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a subject in an emergency.  Such notice must be given as soon as possible, but in no event later 
than five (5) working days after the emergency has occurred.  Except in such an emergency, 
prior written approval by Medtronic is required for changes in or deviations from the Plan.  If 
these changes or deviations affect the scientific soundness of the Plan or the rights, safety, or 
welfare of human subjects the IRB/EC will also be notified. All other deviations will be reported 
per the site’s IRB/EC deviation policy.  Should any deviations from the Investigational Plan 
occur, these will be reviewed by Medtronic for their clinical significance.  If the event is 
performed without written approval from all parties, the investigator may be terminated from the 
study. 
13.3 Confidentiality 
All records identifying the subject will be kept confidential and, to the extent permitted by the 
applicable laws and/or regulations, will not be made publicly available.  
Subject names will be kept confidential. Only the subject’s identifying number will be collected 
on the eCRF, and if the subject name appears on any other document, it must be obliterated. 
Study findings stored on a computer will be stored in accordance with local data protection laws. 
The subjects will be informed in writing that representatives of the sponsor, IRB/ECs, or 
Regulatory Authorities may inspect their medical records to verify the information collected, and 
that all personal information made available for inspection will be handled in strictest confidence 
and in accordance with local data protection laws. Subjects will also be informed that 
information regarding the study that does not include subject identifiers will be posted on 
clinicaltrials.gov. 
If the results of the trial are published, the subject’s identity will remain confidential.  
13.4 Data Access and Publications 
The Medtronic Publication and Authorship Policy is aligned with the International Committee of 
Medical Journal Editors (ICMJE) recommendations (www.icmje.org). Medtronic will seek to 
publish, in appropriate peer-reviewed journals and scientific conferences, results of clinical 
studies where human subjects are involved, regardless of outcome. While study results are 
owned by Medtronic, all data on which a publication is based will be made available to all 
authors as required for their participation in the publication process. Furthermore, data may be 
published or used by study investigators provided that such publication or use is in accordance 
with this this protocol, the Sponsor’s Publication and Authorship Policy, and the Clinical 
Investigation Agreement. Investigators must submit a copy of all manuscripts and/or abstracts to 
Medtronic for review and comment 30 days prior to planned submission. Medtronic 
acknowledges that its right to review and comment shall relate solely to the proprietary, 
licensing, and/or confidential rights Medtronic may have in such proposed publication, rather 
than whether such results and/or opinions are favorable to Medtronic.   

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The publication of substudies, post-hoc analyses, regional results, or single-center experiences 
based on multicenter clinical studies should not precede that of the primary multicenter 
publication, and should cite the primary publication whenever possible, as required by specific 
journal and scientific meeting guidelines.  
Medtronic involvement in a publication (e.g., funding of the study; sponsor of the study; 
collection, analysis, and interpretation of data; professional writing assistance) must be disclosed 
according to journal-specific policies, submission requirements, and prevailing editorial 
standards, in addition to those specified by International Committee of Medical Journal Editors. 
Authors must ensure that an acknowledgement/disclosure statement is included in the body of 
the manuscript for Medtronic to review for accuracy. All authors must also disclose financial or 
personal affiliations that could be considered conflicts of interest as per journal/conference 
requirements. 
To enable health care providers, payers, and patients access to the wealth of Medtronic’s 
research, Medtronic will report its scientific data in accordance with the principles outlined in the 
Guidance Document on Registration and Reporting Results of Company-Sponsored Clinical 
Trials Under FDAAA 2007 (Title VIII).   
13.5 Role of the Steering Committee 
The Steering Committee will consist of Investigators participating in this study, as well as 
appropriate members of Medtronic Clinical and Medical Affairs. The role of the Steering 
Committee is to make recommendations on the design and conduct of the study, the analysis of 
data, and the communication of results in alignment with the Sponsor’s Publication and 
Authorship Policy. 
14.0 
Monitoring Procedures 
Site visits will be conducted by an authorized Medtronic representative to inspect study data, 
subjects’ medical records, and eCRFs in accordance with current ICH GCPs and the respective 
local and national government regulations and guidelines (if applicable).The study investigator 
and the investigating site will permit authorized clinical research personnel and clinical monitors 
from Medtronic and/or designee(s) employed by Medtronic to review completed eCRFs, IRB/EC 
decisions, and Investigator, clinical site records, and facilities relevant to this study at regular 
intervals throughout the study per the monitoring plan.  Additionally, subject charts and clinical 
records will be requested and reviewed so that protocol adherence and source documentation can 
be verified.  The accuracy and quality of the data obtained from the investigator and maintained 
by Medtronic will be confirmed through a structured program of clinical field auditing and 
internal review detailed in the monitoring plan. The timing of site visits and scope of verification 
requirements will be included in the monitoring plan.  Monitoring may be performed with in 
person visits or remotely, when applicable.  

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To ensure the rights, safety, and welfare of study subjects are being maintained, the monitor will 
review training records to ensure all study staff are appropriately trained. If the monitor 
discovers that an investigator is not complying with the signed Investigator Agreement, the 
clinical investigational plan, applicable laws, or any conditions of approval imposed by the 
reviewing IRB/EC or applicable regulatory authority, the monitor will report to the Sponsor and 
take such steps necessary to promptly secure compliance.  If compliance cannot be secured, the 
investigator’s participation in the investigation may be terminated.  
14.1 Data Collection and Processing 
This study will utilize an electronic database.  All data requested on the eCRF are considered 
required.  Data points not collected and/or recorded will be considered deviations unless 
otherwise specified. The Principal Investigator must ensure the accuracy and completeness of the 
recorded data and then provide his/her electronic signature on the appropriate eCRFs.  
Visual and/or computer data review will be performed to identify possible data discrepancies.  
Manual and/or automatic queries will be created in the Oracle remote data capture (RDC) system 
and will be issued to the site for appropriate response.   
15.0 
Study Supplies and Device Accountability 
The superDimension™ navigation system (including associated accessories and tools) are 
commercially available.  Sites will obtain devices through standard site procedures for 
commercially available product.  The devices used during study procedures should be used in 
accordance with approved indication and instructions for use.  
There are no study specific device accountability or traceability requirements for this study. 
16.0 
General Information 
16.1 Study Contact Information 
Questions regarding safety or medical procedures should be directed to Medical Affairs.  All 
other questions should be directed to Clinical Affairs. 

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Clinical Affairs 
Medical Affairs 
 
 
 
 
  
 
 
 
  
16.2 Retention of Records 
The investigator will maintain the records of the study including all pertinent correspondence, 
the study protocol with any/all amendments, all correspondence with and approval from the 
IRB/EC, the clinical investigation agreement, the Investigator Agreement, individual subject 
records, and signed ICFs.  Subject files and other source data must be kept for a period of not 
less than two (2) years after date on which this investigation is terminated or completed.   
Records may need to be maintained by the study investigator for a longer duration if national 
regulations require or if agreed to in writing with Medtronic. All data and documents should be 
made available if requested by relevant authorities. 
16.3 Study Completion/Termination of Study 
Once the study is complete at the site, the investigator must submit a final report to their IRB/EC 
and the sponsor per their IRB/EC requirements. 
Medtronic reserves the right to discontinue the study at any stage, with suitable written notice to 
all investigators, all reviewing IRBs or ECs, and applicable regulatory agencies.  Similarly, 
investigators may withdraw from the study at any time, subject to providing written notification 
to Medtronic 30 days prior to the date they intend to withdraw.  However, Medtronic and 
investigators will be bound by their obligation to complete the follow-up of subjects already 
participating in the study.  The subjects must be followed according to the clinical protocol, and 
information obtained during subject follow-up shall be reported to Medtronic on the appropriate 
eCRF. 
17.0 
References 
1. 
Diederich S. Lung cancer staging update: the revised TNM classification. Cancer 
Imaging. 2010;10:S134-5. 
2. 
Lung. In: Edge SB, Byrd DR, Compton CC, et al., eds.: AJCC Cancer Staging Manual. 
7th ed. New York, NY: Springer, 2010, pp 253-70. 

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3. 
Loo FL, Halligan AM, Port JL, Hoda RS. The emerging technique of electromagnetic 
navigation bronchoscopy-guided fine-needle aspiration of peripheral lung lesions: 
promising results in 50 lesions. Cancer Cytopathol. 2014 Mar;122(3):191-9. 
4. 
Baaklini WA, Reinoso MA, Gorin AB, Sharafkaneh A, Manian P. Diagnostic yield of 
fiberoptic bronchoscopy in evaluating solitary pulmonary nodules. Chest. 2000 
Apr;117(4):1049-54. 
5. 
American Cancer Society. Cancer Facts & Figures 2014. Atlanta: American Cancer 
Society; 2014. Available at: 
http://www.cancer.org/research/cancerfactsstatistics/cancerfactsfigures2014/ (Accessed 
September 11, 2014). 
6. 
Balbo PE, Bodini BD, Patrucco F, Della Corte F, Zanaboni S, Bagnati P, et al. 
Electromagnetic navigation bronchoscopy and rapid on site evaluation added to 
fluoroscopy-guided assisted bronchoscopy and rapid on site evaluation: improved yield in 
pulmonary nodules. Minerva Chir. 2013 Dec;68(6):579-85. 
7. 
Becker HD, Herth F, Ernst A, Schwarz Y. Bronchoscopic Biopsy of Peripheral Lung 
Lesions Under Electromagnetic Guidance: A Pilot Study. J Bronchology Interv 
Pulmonol. 2005;12(1):9-13. 
8. 
Bertoletti L, Robert A, Cottier M, Chambonniere ML, Vergnon JM. Accuracy and 
feasibility of electromagnetic navigated bronchoscopy under nitrous oxide sedation for 
pulmonary peripheral opacities: an outpatient study. Respiration. 2009;78(3):293-300. 
9. 
Brownback KR, Quijano F, Latham HE, Simpson SQ. Electromagnetic navigational 
bronchoscopy in the diagnosis of lung lesions. J Bronchology Interv Pulmonol. 2012 
Apr;19(2):91-7. 
10. 
Diken ÖE, Karnak D, Çiledağ A, Ceyhan K, Atasoy Ç, Akyar S, et al. Electromagnetic 
navigation-guided TBNA vs conventional TBNA in the diagnosis of mediastinal 
lymphadenopathy. Clin Respir J. 2014. 
11. 
Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality 
bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J 
Respir Crit Care Med. 2007 Jul 1;176(1):36-41. 
12. 
Eberhardt R, Anantham D, Herth F, Feller-Kopman D, Ernst A. Electromagnetic 
navigation diagnostic bronchoscopy in peripheral lung lesions. Chest. 2007 
Jun;131(6):1800-5. 
13. 
Eberhardt R, Morgan RK, Ernst A, Beyer T, Herth FJ. Comparison of suction catheter 
versus forceps biopsy for sampling of solitary pulmonary nodules guided by 
electromagnetic navigational bronchoscopy. Respiration. 2010;79(1):54-60. 
14. 
Gildea TR, Mazzone PJ, Karnak D, Meziane M, Mehta AC. Electromagnetic navigation 
diagnostic bronchoscopy: a prospective study. Am J Respir Crit Care Med. 2006 Nov 
1;174(9):982-9. 
15. 
Jensen KW, Hsia DW, Seijo LM, Feller-Kopman DJ, Lamb C, Berkowitz D, et al. 
Multicenter experience with electromagnetic navigation bronchoscopy for the diagnosis 
of pulmonary nodules. J Bronchology Interv Pulmonol. 2012 Jul;19(3):195-9. 
16. 
Karnak D, Ciledag A, Ceyhan K, Atasoy C, Akyar S, Kayacan O. Electromagnetic 
navigation diagnostic bronchoscopy for peripheral lung lesions and mediastinal lymph 
nodes: First results. Turk Toraks Derg. 2011 June;12(2):51-6. 

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17. 
Karnak D, Ciledag A, Ceyhan K, Atasoy C, Akyar S, Kayacan O. Rapid on-site 
evaluation and low registration error enhance the success of electromagnetic navigation 
bronchoscopy. Ann Thorac Med. 2013 Jan;8(1):28-32. 
18. 
Khan AY, Berkowitz D, Krimsky WS, Hogarth DK, Parks C, Bechara R. Safety of 
pacemakers and defibrillators in electromagnetic navigation bronchoscopy. Chest. 2013 
Jan;143(1):75-81. 
19. 
Lamprecht B, Porsch P, Pirich C, Studnicka M. Electromagnetic navigation 
bronchoscopy in combination with PET-CT and rapid on-site cytopathologic examination 
for diagnosis of peripheral lung lesions. Lung. 2009 Jan-Feb;187(1):55-9. 
20. 
Lamprecht B, Porsch P, Wegleitner B, Strasser G, Kaiser B, Studnicka M. 
Electromagnetic navigation bronchoscopy (ENB): Increasing diagnostic yield. Respir 
Med. 2012 May;106(5):710-5. 
21. 
Mahajan AK, Patel S, Hogarth DK, Wightman R. Electromagnetic navigational 
bronchoscopy: an effective and safe approach to diagnose peripheral lung lesions 
unreachable by conventional bronchoscopy in high-risk patients. J Bronchology Interv 
Pulmonol. 2011 Apr;18(2):133-7. 
22. 
Makris D, Scherpereel A, Leroy S, Bouchindhomme B, Faivre JB, Remy J, et al. 
Electromagnetic navigation diagnostic bronchoscopy for small peripheral lung lesions. 
Eur Respir J. 2007 Jun;29(6):1187-92. 
23. 
Mohanasundaram U, Ho LA, Kuschner WG, Chitkara RK, Canfield J, Canfield LM, et al. 
The Diagnostic Yield of Navigational Bronchoscopy Performed with Propofol Deep 
Sedation. ISRN Endoscopy. 2013;2013:1-5. 
24. 
Odronic SI, Gildea TR, Chute DJ. Electromagnetic navigation bronchoscopy-guided fine 
needle aspiration for the diagnosis of lung lesions. Diagn Cytopathol. 2014 
Dec;42(12):1045-50. 
25. 
Pearlstein DP, Quinn CC, Burtis CC, Ahn KW, Katch AJ. Electromagnetic navigation 
bronchoscopy performed by thoracic surgeons: one center's early success. Ann Thorac 
Surg. 2012 Mar;93(3):944-9; discussion 9-50. 
26. 
Schwarz Y, Greif J, Becker HD, Ernst A, Mehta A. Real-time electromagnetic navigation 
bronchoscopy to peripheral lung lesions using overlaid CT images: the first human study. 
Chest. 2006 Apr;129(4):988-94. 
27. 
Seijo LM, de Torres JP, Lozano MD, Bastarrika G, Alcaide AB, Lacunza MM, et al. 
Diagnostic yield of electromagnetic navigation bronchoscopy is highly dependent on the 
presence of a Bronchus sign on CT imaging: results from a prospective study. Chest. 
2010 Dec;138(6):1316-21. 
28. 
Wilson DS, Bartlett RJ. Improved Diagnostic Yield of Bronchoscopy in a Community 
Practice: Combination of Electromagnetic Navigation System and Rapid On-site 
Evaluation. J Bronchology Interv Pulmonol. 2007;14(4):227-32  
29. 
Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and 
safety of electromagnetic navigation bronchoscopy for lung nodules: a systematic review 
and meta-analysis. Respiration. 2014 Jan 3;87(2):165-76. 
30. 
Wiener RS, Wiener DC, Gould MK. Risks of Transthoracic Needle Biopsy: How High? 
Clin Pulm Med. 2013 Jan 1;20(1):29-35. 
 
 

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18.0 
Appendices 
18.1 Sample Patient Informed Consent 
See attached document, “18.1_NAVIGATE_Sample Patient Informed Consent” 
18.2 Lung Cancer Staging 
See attached document, “18.2_NAVIGATE_Lung Cancer Staging” 
 

COVENBP0475 Informed Consent Form template  
Page 1 of 6 
ICF Version E (09NOVP2015) 
 
 
                                           INFORMED CONSENT AND HIPAA FORM  
 
STUDY TITLE:  
NAVIGATE: Clinical Evaluation of superDimension™ 
Navigation System for Electromagnetic Navigation 
Bronchoscopy™ 
 
PROTOCOL No.: 
COVENBP0475 
SPONSOR:   
 
Medtronic, Interventional Lung Solutions  
 
161 Cheshire Lane, Suite 100  
 
Plymouth, MN 55441 USA  
 
 
INVESTIGATOR:  
Name 
 
Address 
 
Phone Number 
 
 
 
 
Email Address 
 
SITE(S): 
 
        
Name  
 
Address 
 
 
IRB:        
Name  
 
Address 
 
Phone Number 
 
Email Address 
 
 
 
INTRODUCTION 
You are being asked to participate in a clinical research study because you are scheduled, as part 
of your normal care, to have an electromagnetic navigation bronchoscopy™ (ENB™) procedure 
using the superDimension™ navigation system. This procedure is not experimental, is approved 
by the Food and Drug Administration (FDA), and the product is commercially available.  This 
study allows your doctor to record the results of your procedure and subsequent care in an 
organized manner.     
 
The purpose of this consent form is to help you decide if you would like to participate in this 
research study.  You will be informed of the purpose, procedures including follow up visits, risks 
and benefits of the study, as well as contact information for any questions you may have.    
Please read and understand the following informed consent document carefully before signing.  
Do not sign this form until all of your questions have been answered. You may take an unsigned 
copy of this form home with you to consider participation or talk about it with family or friends 
before you decide.   
 
WHAT IS THE PURPOSE OF THIS STUDY? 
The purpose of this study is to evaluate clinical outcomes of electromagnetic navigation 
bronchoscopy™ (ENB™) procedures using the superDimension™ navigation system.  

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HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?  
Up to 2,500 patients at up to 75 global sites will take part in the study, including up to 75 
subjects at this site.  All subjects will be followed for 24 months after the procedure.   
 
WHAT WILL HAPPEN IF I TAKE PART IN THE RESEARCH STUDY? 
If you choose to participate in this study, and meet all of the eligibility requirements the 
following study procedures will take place.    
 
Screening Visit 
You will be evaluated within 30 days before your scheduled procedure to assess your eligibility.  
At this time, you doctor will decide if you qualify, and you will be asked to read, understand, and 
sign this informed consent document.  Additionally, your medical history (including smoking 
history, risk factors and certain medications) and demographic information will be collected. 
You will also be asked questions on your quality of life.       
 
Procedure 
Your doctor will perform the procedure as planned and any complications will be recorded. 
During the procedure visit, your general health will be evaluated.  
 
After the procedure visit, you will be required to follow the visit schedule and have examinations 
performed as listed below.   
 
1 Month Follow-up Visit  
At your first follow-up visit, your general health will be evaluated since your last visit. You will 
also be asked questions on your quality of life, your patient satisfaction and the effect of the 
ENB™ procedure on your work productivity and activities.       
 
12 Month Follow-up Visit  
At your 12 month follow-up visit, your general health will be evaluated since your last visit. You 
will also be asked questions on your quality of life.       
 
24 Month Follow-up Visit  
 At your 24 month follow-up visit, your general health will be evaluated since your last visit. 
You will also be asked questions on your quality of life.       
 
WHAT ARE THE RISKS?  
This is an observational study.  The risks associated with an observational study are the loss of 
confidentiality and privacy.  All records identifying you will be kept confidential and will not be 
made publically available to the extent permitted by the applicable laws or regulations. 
There are no anticipated risks related to participation in this clinical study above and beyond 
anticipated risks related to any ENB™ procedure. Your doctor will review the risks of an ENB™ 
procedure with you.  
 
ARE THERE ANY ADDITIONAL COSTS TO ME?  

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If you agree to participate in this study, you or your insurance provider will be charged for any 
procedures that are consistent with the standard of care for this type of procedure.  Medtronic 
will pay for any additional tests or procedures necessary for the study that would not otherwise 
be a part of your routine clinical care.   
 
If you have any questions or concerns about the cost, coverage or types of tests and procedures 
that will be conducted, please ask your study doctor. 
 
PAYMENTS  
You will not be paid for participating in this study.   
 
WHAT ARE THE BENEFITS?  
 This study may or may not be of direct benefit to you.  However, your participation may help 
Medtronic to establish additional data on this device for the diagnosis and treatment of lung 
lesions.   Other people may benefit from the results of this study in the future.   
 
ARE THERE ANY ALTERNATIVE TREATMENTS AVAILABLE?  
This is not a treatment study.  Your alternative is not to have your data from this procedure 
collected. 
 
WHAT IF I AM INJURED DURING MY PARTICIPATION IN THE STUDY? 
If you have side effects from the procedure, you need to report them to your study doctor and 
your regular doctor, and you will be treated as needed.  You or your insurance will be billed for 
these services.  Medtronic has not agreed to pay you if you believe you are injured.  You are not, 
however, waiving any of your legal rights by signing this form.  As stated previously, 
participation in this study does not add any additional risk to you over and above having an 
ENB™ procedure performed while not in this study.  
 
CAN I WITHDRAW FROM THE STUDY?   
Your participation in this study is completely voluntary. You have the right to decline 
participation or withdraw from the study at any point in time.   Choosing to do so will not have 
any penalties to you, and will not affect the medical care or benefits you receive from your 
doctor.   Your study doctor may also withdraw you from the study if they feel it is in your best 
interest.  In addition, the sponsor may discontinue the study at any time without your knowledge.  
If this happens, you will be notified.   
 
CONFIDENTIALITY 
As part of this study, the study doctor and hospital will keep records of your participation in the 
study.  This section of the consent form describes how your personal information may be used 
and shared as part of the study.  Under federal law, your personal information cannot be used or 
shared for the study by the Researchers unless you sign this form.  You do not have to sign this 
form.  If you do not sign it, you will not be able to be in the study, but it will have no other effect 
on the medical care you receive. 
 

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A description of this clinical trial will be available on http://www.clinicaltrials.gov, as required 
by U.S. Law. This Web site will not include information that can identify you. At most, the Web 
site will include a summary of the results. You can search this Web site at any time. 
 
 
What information about me can be used or shared in the study? 
The personal information that may be used or shared is: 
 
All information collected during the study described in this form, including your gender, 
age, treatment dates, device identifiers, procedure and test results and other information 
from your medical records. 
 
Information in your past medical records that relates to the study. 
When you see the phrase “personal information” in this form, it means all of this information.  
 
Who are the Researchers? 
As part of the study, your personal information may be kept by the hospital, site and study 
doctor), and the people who work for them.  The people who work with them include the 
Institutional Review Board, which is a group of people who watch over the study for the 
hospital.  It also includes other employees and contractors who need to see your personal 
information to help with the study or make sure it is being run right.  When you see the word 
“Researchers” in this form, it refers to all of these people. 
 
Who is the Sponsor of the study? 
The sponsor of the study is Medtronic.  The Sponsor’s employees are the main people who work 
on the study, but Medtronic may also contract with other companies and people to help it run its 
business.  When you see the word “Sponsor” in this form, it means the company, Medtronic, and 
any other people or companies helping it.   
 
What can the Researchers do with my personal information? 
The Researchers can: 
 
Use and share your personal information to conduct the study and evaluate the results of 
the study. 
 
Use and share your personal information to meet the reporting requirements of 
government agencies. 
 
Use and share your personal information to prepare publications or presentations (but no 
publication about the study will reveal your identity without a different specific, written 
permission from you). 
 
Disclose your personal information to the people listed in the next section of this form. 
 
Remove from your personal information your name and other information that could be 
used to identify you. 
 
Use and share your personal information as required by law. 
 
Who can the Researchers disclose my personal information to? 
The Researchers can disclose your personal information to people working with any of the 
following groups: 
 
The Sponsor of the study; 
 
Other institutions that are participating in the study; 

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 
Government organizations and other persons (such as the Medical Monitor) who are 
required to watch over the safety, effectiveness, and conduct of research; and 
 
Government agencies that have the right to see or review your health information. This 
includes the Office of Human Research Protections, the Food and Drug Administration, 
Institutional Review Boards, or similar agencies in other countries. 
 
What can the Sponsor do with my personal information? 
After your personal information has been shared with the Sponsor, the Sponsor may use and 
share it, in the United States or throughout the world, for any of the following reasons: 
 
To conduct, monitor and audit the study, and to confirm research results; 
 
To prepare publications or presentations (but no publication about the study will reveal 
your identity without a different specific, written permission from you); 
 
For regulatory purposes, such as getting the approval of government agencies to sell 
products made by the Sponsor; 
 
To conduct new medical research and develop proposals for new medical products or 
therapies; 
 
To share it with government organizations and other persons who are required to watch 
over the safety and effectiveness of products, therapies, and the conduct of research; 
 
It may be used and shared as required by law. 
 
Can I decide not to allow the use and sharing of my personal information? 
Yes. You do not have to sign this form.  However, if you do not sign this form, then you cannot 
participate in the study. 
 
Can I revoke (take back) my signature on this form? 
Yes. You can change your mind about letting your personal information be used or shared at any 
time by letting the study doctor know in writing.  If you change your mind, you will be taken out 
of the study.  No personal information about you will be gathered for the study after that date.  
However, the personal information gathered before you told the study doctor that you changed 
your mind may continue to be used or shared by the Researchers and Sponsor if it is needed for 
the study or any follow-up for the study.  If you think it is likely that you will change your mind, 
please do not sign this form.   
 
Is my personal information protected after it has been disclosed to others? 
After the Researchers have shared your personal information with others, including the Sponsor, 
federal laws may not protect it from being further shared.    
 
Can I see my personal information? 
Yes. You may see and copy your information.   
 
Does this form have an expiration (end) date? 
The Researchers may use and share your information until the study and any necessary follow-up 
activities for the study are done.  There is no end date for when the Sponsor can use your 
personal information. If the results of the trial are published, your identity will remain 
confidential.   
 

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NEW INFORMATION 
You will be told about anything new that might change your decision to be in this study.  You 
may be asked to sign a new consent form if this occurs.  
 
WHO CAN I CONTACT WITH QUESTIONS?  
If at any time, you have questions regarding this research study please contact your study doctor 
as noted on the first page. 
 
If at any time you have questions about your rights as a participant, or questions regarding any 
research related injury, please contact a member of the hospital’s Institutional Review Board as 
noted on the first page 
 
A signed and dated copy of this consent form will be provided to you.   
 
INFORMED CONSENT 
I have read this consent form (or it has been read to me).  All my questions about the study and 
my part in it have been answered.  I freely consent to be in this research study. 
I authorize the use and disclosure of my health information to the parties listed in the 
authorization section of this consent for the purposes described above. 
 
By signing this consent form, I have not given up any of my legal rights. 
 
______________________________________ 
 
Patient Name (Print) 
 
 
 
  
 
 
 
____________________________________ 
                 ______________ 
Signature of Participant 
        
 
 
 
 
Date  
 
 
 
____________________________________    
 
     ______________ 
Signature of Person Obtaining Consent 
 
 
      Date  

7th EDITION
Primary Tumor (T) Classification  
	
TX 	 Primary tumor cannot be assessed, or tumor 
proven by the presence of malignant cells 
in sputum or bronchial washings but not 
visualized by imaging or bronchoscopy
	
T0 	 No evidence of primary tumor
	
Tis 	 Carcinoma in situ
	
T1 	 Tumor 3 cm or less in greatest dimension, 
surrounded by lung or visceral pleura, 
without bronchoscopic evidence of invasion 
more proximal than the lobar bronchus
	 T1a 	 Tumor 2 cm or less in greatest dimension
	 T1b 	 Tumor more than 2 cm but 3 cm 
or less in greatest dimension
	
T2 	 Tumor more than 3 cm but 7 cm or less or 
tumor with any of the following features (T2 
tumors with these features are classified T2a 
if 5 cm or less): involves main bronchus, 2 cm 
or more distal to the carina; invades visceral 
pleura (PL1 or PL2); associated with atelectasis 
or obstructive pneumonitis that extends to the 
hilar region but does not involve the entire lung
	 T2a 	 Tumor more than 3 cm but 5 cm 
or less in greatest dimension
	 T2b 	 Tumor more than 5 cm but 7 cm 
or less in greatest dimension
	
T3 	 Tumor more than 7 cm or one that directly 
invades any of the following: parietal 
pleural (PL3), chest wall (including superior 
sulcus tumors), diaphragm, phrenic nerve, 
mediastinal pleura, parietal pericardium; or 
tumor in the main bronchus less than 2 cm 
distal to the carina1 but without involvement 
of the carina; or associated atelectasis or 
obstructive pneumonitis of the entire lung or 
separate tumor nodule(s) in the same lobe
	
T4 	 Tumor of any size that invades any of the 
following: mediastinum, heart, great vessels, 
trachea, recurrent laryngeal nerve, esophagus, 
vertebral body, carina, separate tumor 
nodule(s) in a different ipsilateral lobe
Classifications
Distant Metastasis (M) Classification
	 M0 	 No distant metastasis
	 M1 	 Distant metastasis
	 M1a 	 Separate tumor nodule(s) in a contralateral 
lobe, tumor with pleural nodules or 
malignant pleural (or pericardial) effusion
	 M1b 	 Distant metastasis (in extrathoracic organs)
A m e r i c a n  J o i n t  C o m m i t t e e  o n  C a n c e r
Lung Cancer Staging
Copyright 2012 American Joint Committee on Cancer  •  Printed with permission from the AJCC.
Financial support  for AJCC 7th Edition Staging Posters 
provided by the American Cancer Society
1 of 2
ANATOMIC STAGE/PROGNOSTIC GROUPS
Occult Carcinoma 
TX 
N0 
M0
Stage 0 
Tis 
N0 
M0
Stage IA 
T1a 
N0 
M0
T1b 
N0 
M0
Stage IB 
T2a 
N0 
M0
Stage IIA 
T2b 
N0
M0
T1a 
N1 
M0
T1b 
N1 
M0
T2a 
N1 
M0
Stage IIB 
T2b 
N1 
M0
T3 
N0 
M0
Stage IIIA 
T1a 
N2 
M0
T1b 
N2 
M0
T2a 
N2 
M0
T2b 
N2 
M0
T3 
N1 
M0
T3 
N2 
M0
T4 
N0 
M0
T4 
N1 
M0
Stage IIIB 
T1a 
N3 
M0
T1b 
N3 
M0
T2a 
N3 
M0
T2b 
N3 
M0
T3 
N3 
M0
T4 
N2 
M0
T4 
N3 
M0
Stage IV 
Any T 
Any N 
M1a
Any T 
Any N 
M1b

7th EDITION
A m e r i c a n  J o i n t  C o m m i t t e e  o n  C a n c e r
Lung Cancer Staging
Copyright 2012 American Joint Committee on Cancer  •  Printed with permission from the AJCC.
Regional Lymph Node (N) 
Classification
	
NX 	 Regional lymph nodes 
cannot be assessed
	
N0 	 No regional lymph 
node metastases
	
N1 	 Metastasis in ipsilateral 
peribronchial and/or 
ipsilateral hilar lymph nodes 
and intrapulmonary nodes, 
including involvement 
by direct extension
	
N2 	 Metastasis in ipsilateral 
mediastinal and/or 
subcarinal lymph node(s)
	
N3 	 Metastasis in contralateral 
mediastinal, contralateral 
hilar, ipsilateral or 
contralateral scalene, or 
supraclavicular lymph node(s)
Financial support  for AJCC 7th Edition Staging Posters 
provided by the American Cancer Society
ILLUSTRATION
The IASLC lymph node map shown 
with the proposed amalgamation 
of lymph into zones.
(© Memorial Sloan-Kettering 
Cancer Center, 2009.)
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