Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes.
Conditions: Lung Lesion(s) Requiring Evaluation, Pulmonary Metastasis, Pulmonary Nodule, Solitary, Peripheral Lung Lesions
Sponsor: Veran Medical Technologies

 
 
 
 NCT04066699 
Percutaneous 
Localization: Open-
label Registry of 
Thoracic Surgery 
(PLOTS) 
 IRB Approved Protocol – 2 November 2020 
 
 

Veran Medical Technologies, Inc. 
The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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THE PLOTS REGISTRY 
STUDY PROTOCOL 
 
 
 
TITLE 
Intraoperative, Percutaneous Localization of Peripheral 
Pulmonary Nodules for Resection: a Prospective, Open-Label, 
Multi-Center Registry Study of Thoracic Surgery Outcomes. 
PROTOCOL/STUDY NO. 
VMT-01-003 
WESTERN IRB 
TRACKING NO. 
20191713 
VERSION 
Current: 02November2020 
Prior: 11June2019 
Amendment #: 1 
SPONSOR 
Veran Medical Technologies, Inc. 
1938 Innerbelt Business Center Drive 
St. Louis, MO 63114 USA 
CONDUCTED BY 
Veran Medical Technologies, Inc. 
1938 Innerbelt Business Center Drive 
St. Louis, MO 63114 USA 
 
 
Confidentiality Statement 
The information in this document is Veran Medical Technologies, Inc., confidential information. 
This material may be used only for evaluating or conducting clinical investigations; any other 
proposed use requires written consent from Veran Medical Technologies, Inc. Acceptance of this 
document constitutes an agreement by the recipient(s) that no unpublished information contained 
herein will be published or disclosed without first obtaining explicit, written approval from 
Veran Medical Technologies, Inc. This document may be disclosed to appropriate 
Investigational Review Boards/Ethics Committees under the condition of confidentiality. 

Veran Medical Technologies, Inc. 
The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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Table of Contents 
Principal Investigator’s Signature Page ...................................................................................... 4 
Short Study Title: PLOTS Registry ........................................................................................... 4 
Veran Medical Technologies Signature Page ............................................................................ 5 
Informational Contacts ............................................................................................................. 6 
List of Abbreviations ................................................................................................................. 7 
Study Synopsis ........................................................................................................................... 8 
1. Statement of Compliance .................................................................................................... 15 
2. BACKGROUND .................................................................................................................. 15 
3. RATIONALE ....................................................................................................................... 17 
TABLE 1 – Schedule of Events .............................................................................................. 18 
4. OBJECTIVES ...................................................................................................................... 20 
4.1 Primary Objective ............................................................................................................... 20 
4.2 Safety Objective .................................................................................................................. 20 
4.3 Secondary Objectives .......................................................................................................... 20 
5. Summary of Registry Design .............................................................................................. 21 
6. DEVICE DESCRIPTION ................................................................................................... 21 
6.1 Materials Used .................................................................................................................... 22 
6.2 Other Medical Devices ........................................................................................................ 23 
6.3 Instructions for Use ............................................................................................................. 23 
7. PRIOR CLINICAL DATA ................................................................................................. 23 
8. RISKS AND BENEFITS .................................................................................................... 25 
8.1 Registry Data Collection – Risks and Benefits ................................................................... 25 
8.2 Procedural Data Collection – Risks and Benefits .............................................................. 26 
9. RESEARCH METHODS AND DATA COLLECTION ................................................. 27 
9.1 Primary Efficacy Objective: Successful Percutaneous Localization of PPN ...................... 28 
9.2 Safety Objective .......................................................................................................................................... 29 
9.3 Subject Enrolment and Informed Consent .......................................................................... 30 
9.4 Withdrawal of Subjects ....................................................................................................... 30 
9.5 Screen Failures .................................................................................................................... 30 
9.6 Pre-procedure Chest CT Scan Evaluation ........................................................................... 30 
9.7 Non-contrast Chest CT ....................................................................................................... 31 
10. COMPLAINT AND SAFETY REPORTING ................................................................. 32 
10.1 Complaint Reporting ......................................................................................................... 32 
10.2 Safety Reporting ............................................................................................................... 32 
10.3 Adverse Events − Data Collection for Localization Events .............................................. 33 
10.3.1 Serious Adverse Event .................................................................................................. 34 
10.4 Causality − Adverse Event Relationship ........................................................................... 34 
10.5 Adverse Event Outcome ................................................................................................... 34 
10.6 Adverse Event Recording ................................................................................................. 35 
11. STATISTICAL METHODS ............................................................................................. 35 
11.1 Sample Size ....................................................................................................................... 35 
11.2 Data Analyses .................................................................................................................... 35 
11.2.1 General Considerations .................................................................................................. 35 
11.2.2 Handling of Missing Data .............................................................................................. 36 
12. STUDY MANAGEMENT ................................................................................................ 36 

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12.1 Overall Study Management ............................................................................................... 36 
12.2 File Retention and Archiving ............................................................................................ 37 
12.3 Data Management ............................................................................................................. 37 
12.4 Changes to the Protocol .................................................................................................... 38 
12.5 Study Governance ............................................................................................................. 38 
12.6 Publication Policy ............................................................................................................. 38 
13. PROTOCOL COMPLIANCE ......................................................................................... 38 
14. DATA STORAGE AND MAINTENANCE .................................................................... 39 
15. ETHICAL AND REGULATORY CONSIDERATIONS .............................................. 40 
15.1 Guiding Principles and Regulations .................................................................................. 40 
15.2 Site Required Documents .................................................................................................. 40 
15.3 Patient Information and Informed Consent ....................................................................... 40 
15.4 Patient Confidentiality ...................................................................................................... 41 
15.5 Independent Ethics Committee/Institutional Review Board ............................................. 41 
16. REFERENCES .................................................................................................................. 42 
Appendix A – Instructions for Use ........................................................................................ 44 
Appendix B – Veran CT Scan ................................................................................................ 45 
Appendix C – Safety and Complaint Reporting Forms ...................................................... 46 

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The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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Principal Investigator’s Signature Page 
Short Study Title: PLOTS Registry 
Intraoperative, Percutaneous Localization of Peripheral Pulmonary Nodules for Resection: a 
Prospective, Open-Label, Multi-Center Registry Study of Thoracic Surgery Outcomes. 
 
I have read and understand the protocol and agree that it contains the ethical, legal, and 
scientific information necessary to participate in this study. My signature confirms that 
the study will be conducted in accordance with the protocol and all applicable laws and 
regulations including, but not limited to the Requirements of 21 CFR 50 and 56; 21 CFR 
11; 21 CFR 803; 21 CFR 812.2(c); 45 CFR 46 , as they relate to medical device 
registries of marketed commercial devices used within their labeled indication and 
instructions for use. 
I will provide copies of this protocol as needed to all physicians, nurses, and other 
professional personnel responsible to me who will participate in the Study. I will discuss 
the protocol with them to assure myself that they are sufficiently informed regarding the 
conduct of the Study. I am aware that this protocol will need to be approved by an 
appropriate Institutional Review Board (IRB) prior to any subjects being enrolled and 
that I am responsible for verifying whether that requirement is met. I agree to adhere to 
the attached protocol and if requested to provide copies of medical information for the 
purpose of verification of submitted information. 
Since the information in this protocol is confidential, I understand that its disclosure to 
any third parties, other than those involved in approval, supervision, or conduct of the 
study is prohibited. I will ensure that the necessary precautions are taken to protect such 
information from loss, inadvertent disclosure, or access by third parties. 
Investigator: 
 
 
Print Name 
 
 
Signature 
Date 
 
 
Print Name of Institution or Practice and Location 
 
 
 
RETURN ORIGINAL TO Veran Medical Technologies 
RETAIN COPY FOR INVESTIGATOR FILE 

Veran Medical Technologies, Inc. 
The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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Veran Medical Technologies Signature Page 
 
 
 
 
 
Reviewed and Approved by: 
 
 
 
 
 
Name 
Signature 
Title 
Date 
Name 
Signature 
Title 
Date 

Veran Medical Technologies, Inc. 
The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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INFORMATIONAL CONTACTS 
 
Sponsor: 
Veran Medical Technologies, Inc. 
 
Clinical Study Director: 
Nathan Hunt 
Vice President, Quality Assurance & Regulatory Affairs 
 
Veran Medical Technologies, Inc. 
1938 Innerbelt Business Center Drive 
St. Louis, MO 63114 
Office: +1 (314) 659-8500 
Mobile: +1 (314) 334-5363 
Nathan.Hunt@veranmedical.com 
 
 
Clinical Operations Group responsible for the management of the study: 
 
Veran Medical Technologies, Inc. 
Cody Zimmerman, Clinical Research Associate II 
Cody.Zimmerman@veranmedical.com 
 
Amanda Meyer, Clinical Research Associate II 
Amanda.Meyer@veranmedical.com 
 
Department of Global Clinical Operations 
1938 Innerbelt Business Center Drive 
St. Louis, MO 63114 
PLOTS@veranmedical.com 

Veran Medical Technologies, Inc. 
The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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LIST OF ABBREVIATIONS 
 
ACCP 
American College of Chest Physicians 
AE 
Adverse event 
ASCO 
American Society of Clinical Oncology 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CT 
Computed Tomography 
CTCAE 
Common terminology for adverse events 
DLCO 
Diffusing capacity of the lungs for carbon monoxide 
EBUS 
Endobronchial ultrasound 
eCRF 
Electronic case report form 
ECG 
Electrocardiogram 
EDC 
Electronic data capture 
EMN 
Electromagnetic navigation 
FB 
Flexible bronchoscopy 
FDA 
US Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
Informed consent form 
ICH 
International Conference on Harmonization 
ACMJE 
American Committee of Medical Journal Editors 
IFU 
Instructions for Use 
IRB 
Institutional review board 
IR 
Interventional Radiologist/Radiology 
Kg 
Kilogram 
LDCT 
low-dose computed tomography 
mcg 
Microgram (µg) 
mg 
Milligram 
mL 
Milliliter 
MedDRA 
Medical Dictionary for Regulatory Activities 
MIV 
Minimally invasive 
mm 
Millimeter 
NCCN 
National Comprehensive Cancer Network 
PI 
Principal Investigator 
PPN 
Peripheral pulmonary nodules 
SAE 
Serious adverse event 
SD 
Standard Deviation 
SOP 
Standard Operating Procedures 
SPiN or SPiN System 
SPiN Thoracic Navigation System™ 
US 
United States of America 
VATS 
Video assisted thoracoscopic surgery 
VERAN 
Veran Medical Technologies, Inc. 

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The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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STUDY SYNOPSIS 
 
SPONSOR 
Veran Medical Technologies, Inc. 
PRODUCT 
SPiN Thoracic Navigation System™, including Localization 
Needles, SPiN Perc™ Kit, other accessories per investigator 
discretion 
TITLE 
Intraoperative, Percutaneous Localization of Peripheral 
Pulmonary Nodules for Resection: a Prospective, Open-Label, 
Multi-Center Registry Study of Thoracic Surgery Outcomes. 
STUDY NUMBER 
VMT-01-003 
STUDY PHASE 
Post-marketing Registry/IV 
LOCATION 
This trial will be conducted at approximately 5 sites across the 
US. 
NUMBER OF 
SUBJECTS 
The study aims to report 70-100 subjects. Each site is expected to 
enroll a minimum of 6 subjects. 
OBJECTIVES 
The registry is aimed developing a high-quality set of data 
regarding intraoperative percutaneous localization of peripheral 
pulmonary nodules (PPNs), and then identifying and 
promulgating efficient, evidence-based best practices for this 
technique. The resection procedure itself is standard of care and 
follows the investigator’s standard protocol. 
Successful localization of PPNs is a challenge involving multiple 
factors, beginning with the subjects’ health, lung function and 
also factors specific to the nodule including location within the 
lung, size, distance from the lung surface, whether solid or 
ground glass and proximity to a fissure. Hard to see or palpate 
nodules are currently localized with dye and/or hook wires or 
fiducials, either endoscopically or percutaneously. Successful, 
large, prospective studies have not been reported using modern 
electro-magnetic navigation (EMN)-guided percutaneous 
intraoperative localization, and different techniques (dye vs. 
fiducial vs. hook wire etc.) have not been evaluated. It is for 
these reasons that the different localization techniques used with 
EMN-guided percutaneous localization will be collected for 
patients having a suspicious nodule and who undergo 
percutaneous intra-operative localization and immediate 
resection. 
This registry aims to record the localization techniques used by 
thoracic surgeons and IP/surgical teams to identify PPNs using 
the SPiN Thoracic Navigation System™ in the hands of trained 
physicians. The objectives of this study will be to accomplish the 

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The PLOTS Registry Study 
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primary and secondary objectives listed below, and to observe 
localization in a real-world context of pulmonary resection. 
PRIMARY 
OBJECTIVE 
Successful percutaneous localization of PPN. 
This is defined as the percentage of subjects in whom the nodule 
is successfully localized and removed in the first resected 
specimen. A pathological specimen with clear margins will count 
as a successful localization. 
SAFETY 
OBJECTIVES 
1. Report the incidence of device-related adverse events that 
occur during the localization procedure. 
SECONDARY 
OBJECTIVES 
1. Report localization methods and techniques – dye and 
materials used, volume of dye (methylene blue, ICG etc.), 
other materials such as microcoils, hook wires etc. 
Details regarding these techniques will be collected. 
2. Collect data on intraoperative percutaneous localization 
time and duration of total surgical procedure. 
3. Record nodule characteristics, including location in the 
lobe, distance from pleura, distance from surface of skin 
to target, morphological appearance, solid vs ground glass 
etc. 
4. Record weight of excised tissue and margin. 
5. Report type of surgical resection performed 
(segmentectomy or wedge) and resection technique 
(VATS, RATS, thoracotomy). 
STUDY DESIGN 
The registry is designed to collect data about subjects who fall 
within the current practice, and to better understand effective 
intraoperative localization techniques used by thoracic surgeons 
to localize small, suspicious lesions just prior to surgery. The 
SPiN System and tools are a medical device that is 510(k) exempt 
under 21 CFR 812.2(c)(2), which applies to the investigation. The 
510(k) product is being used in accordance with the product 
labeling (Appendix A). 
This is a prospective, multicenter, open-label, single arm registry 
to record the safety, efficacy, and methodology of percutaneous, 
intraoperative localization of PPNs immediately prior to lung 
resection. As such, it is a technical procedure registry designed to 
better understand the various factors which affect percutaneous 
localization. 
Thoracic surgeons of varying levels of experience in EMN- 
guided percutaneous localization will be trained on localization 
tools and techniques using the SPiN System – with didactic peer- 
to-peer presentations, followed by device training and hands-on 
experience with phantoms and/or cadavers. 

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The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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The study will enroll between 70 and 100 subjects who fall within 
current clinical practices to have their PPNs removed at 
approximately 5 geographically diverse sites across the US. 
These subjects will undergo intraoperative, EMN-aided 
percutaneous nodule localization and subsequent resection as part 
of their normal care. Safety data (adverse and severe adverse 
events) regarding these subjects will be collected for the 
localization procedure. 
All surgical and post-surgical treatment decisions and clinical 
assessments will be at the discretion of the subject’s thoracic 
surgeon. Eligible subjects from participating sites will be enrolled 
following identification of a qualifying nodule, and meeting 
inclusion/exclusion criteria and completing informed consent. 
Data Collection 
Registry data will be collected before, during, and after the 
procedure from the subject’s medical records by site personnel. 
Based on current clinical practice, it is anticipated that subjects 
will be seen following nodule identification and workup to 
determine the treatment plan and preparation for surgery 
(baseline visit). The size and location of the nodule, demographic 
data and data about smoking history will be collected. 
Comorbidities will be collected from medical history, and the 
subject’s lung function test results collected. 
The subject will return to the site for surgery. A non-contrast 
chest CT scan is recommended within 24 hours/same day as 
surgery, as a clinically indicated procedural planning tool 
(Appendix D – Veran CT scan). Otherwise, a non-contrast chest 
CT scan within the past 15 days is adequate. Subjects are 
typically given general anesthesia for surgery. The localization 
technique and material used will be recorded, including volume 
and type of dye, which needle used, and any other fiducial 
markers (e.g. microcoil). Localization procedure-related adverse 
events and device-related adverse events will be recorded. The 
type and technique of resection performed will be collected 
(VATS, RATS, thoracotomy, etc.). Subjects recover in hospital 
and are discharged per standard of care. Any localization-related 
adverse events will be reported, however the overall lung surgery 
procedure itself is not being studied (approved indication). 
Subjects will typically return to the clinic a few times to be seen 
for scheduled post-operative visits to monitor recovery. 
A secure, site portal that is 21 CFR part 11 compliant is used for 
the electronic data entry and reporting at each site, which includes 
appropriate firewalls between sites and users to protect subject 

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PHI and privacy. All data collected into the study database will 
be de-identified at the site level. 
STUDY PROCEDURES 
Subjects are treated for lung resection according to the treatment 
devised by their clinician. 
Part of the technical procedure registry trains thoracic surgeons 
on the various available tools and techniques in intraoperative 
localization, using both didactic review, best practices, case 
review, and a cadaver lab. 
The following represents the typical standard of care for this 
procedure. The registry study is nested within the standard lung 
resection operation, and study procedures on data collection are 
described within the context of these procedures for clarity of 
identification: 
Following nodule identification and referral, subjects are 
typically evaluated per the subject inclusion/exclusion criteria. 
Review of the subject’s CT/PET scan demonstrate a PPN that is 
between 0.4 cm and 3.2 cm in its longest dimension. All subjects 
will sign and date an Informed Consent Form (ICF) before 
enrollment (Baseline Visit). 
Subjects will undergo a chest CT scan on the day of surgery, 
verifying the longest dimension of the nodule (data collected). 
The subject is put under general anesthesia. The SPiN 
Percutaneous nodule localization procedure is performed 
intraoperatively, using dye and/or other localization techniques. A 
surgical resection (wedge, segmentectomy etc.) will follow, 
according to PI’s judgment. Subjects are generally hospitalized 
between 2-5 days following this procedure and discharged. 
Following discharge, subjects typically follow a schedule of 
multiple clinic visits, as determined by their healthcare team. 
Subject participation in the localization registry will end 
following hospital discharge. 
ESTIMATED 
DURATION OF 
STUDY 
The Registry is anticipated to take 24 months to complete. 

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The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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STUDY POPULATION 
The target subject population includes adult subjects (18 years-85 
years), with PPNs. In the judgment of the thoracic surgeon, 
localization for resection is warranted via a percutaneous 
localization approach. The establishment of malignancy is not 
necessary for PPN removal. 
Data will be collected from study subjects having a PPN between 
0.4 cm and 3.2 cm in greatest dimension, that are accessible to 
percutaneous localization, who consent to and undergo 
intraoperative dye/wire localization procedure followed by 
surgical lung resection. 

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The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
November 2, 2020 
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DIAGNOSIS AND 
MAIN CRITERIA 
FOR INCLUSION 
Subjects will be eligible to enroll into the registry if they have 
given their informed consent and also meet the following criteria: 
Inclusion criteria: 
• Subject’s physician and/or thoracic surgeon have 
deemed/has deemed that the surgical removal of the PPN 
is appropriate. 
• A clinical decision has been made to use the SPiN 
Thoracic Navigation System™. 
• Subject is at least 18 years of age at time of study entry. 
• Subject is able to read, understand, and voluntarily sign 
the IRB-approved informed consent document prior to the 
performance of any study-specific procedures. IRB- 
approved translation may be used if indicated. Reasonable 
accommodation of visually impaired subjects will be 
allowed. 
• Subject is able to tolerate general anesthesia. 
• Subject has a target nodule between 0.4 cm and 3.2 cm in 
greatest dimension; 
• The target nodule is in a location that is accessible for 
percutaneous localization in the judgement of the surgeon. 
Exclusion criteria: 
• Subjects with any other concomitant treatment or medical 
condition that, in the opinion of the clinician, would 
render peripheral nodule resection more hazardous than 
beneficial. 
• Subject is pregnant. 
• Pulmonary nodule is greater than 3.2 cm. 
• Subjects with significant coagulopathy having INR >2.0 
or PTT> 2x normal. 
• Subject is unable to tolerate general anesthesia 
• Obese subject, impacting percutaneous access (BMI >50) 
TEST PRODUCT AND 
MODE OF 
ADMINISTRATION 
Localization of nodules will be completed with the SPiN 
Thoracic Navigation System™, and the corresponding tools that 
allow for percutaneous access. These include the SPiN Perc™ Kit 
and the 1 cm and 2 cm Localization Needles. Please refer to 
protocol section 5, and also the IFU and product information 
(Appendix A). Investigators are trained in the use of the tools and 
the system. 

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The PLOTS Registry Study 
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REFERENCE 
THERAPY 
Historical data as available. 
DURATION OF 
SUBJECT 
INVOLVEMENT 
Duration of treatment studied during the registry will be up to 
approximately 6 weeks per subject, including screening and 
baseline visits, surgery, and hospital visit. 
SAFETY 
ASSESSMENTS 
Localization-related events will be collected. 
STATISTICAL 
ANALYSIS 
Statistical Considerations 
This is a registry study where no formal hypothesis is being 
tested. Data collected during the study will be summarized using 
descriptive statistics and graphical displays. Generally, 
demographic and other descriptive characteristics will be 
described as counts and percentages for categorical variables and 
as measures of central tendency (mean, median, standard 
deviation [SD], and range) for continuous variables. Ninety five 
percent (95%) confidence intervals will be presented for key 
variables and measures of effect. In some cases, data may be 
summarized by demographic, response, or treatment subgroups 
(for example by age, sex, nodule size, smoking history and post- 
surgical smoking pack years, pulmonary function tests, etc.). No 
adjustments will be made for multiple comparisons. All 
localization-related adverse events will be listed and summarized. 
Interim and Final Analyses 
Data collected during the study, which is open-label and non- 
randomized, will be analyzed and reported periodically by an 
executive steering committee comprised of thoracic surgeons. 
When the study is completed, a final analysis will be performed 
and reported. 
DATE OF ORIGINAL 
PROTOCOL 
June 11, 2019 
DATE OF 
AMENDMENT 
November 2, 2020 

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The PLOTS Registry Study 
Protocol/Study No.: VMT-01-003 
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1. STATEMENT OF COMPLIANCE 
 
This human subject study will comply with all applicable federal, state, and local laws and 
regulations, including generally accepted standards of good clinical practice as adopted by 
current Food and Drug Administration (“FDA”) regulations and statutes. Participating study 
sites shall only allow individuals who are appropriately trained and qualified to assist in the 
conduct of the Study. 
2. BACKGROUND 
 
Within the past several years, small and suspicious pulmonary nodules have raised a difficult 
issue for internal medicine physicians, pulmonologists, interventional radiologists, and 
cardiothoracic surgeons. Depending upon the size, location, and type of nodule, they can be 
challenging to precisely locate and remove. The nodules, including those studied here between 
0.4 cm and 3.2 cm along their longest axis, are often found incidentally usually on Computed 
Tomography (CT) scans and sometimes on chest X-rays. In studies of incidentally detected 
nodules, the prevalence of malignancy ranges from 2-82% (Wahidi et al, 2007). 
 
There is an opportunity to develop efficient tools and procedures to more precisely target these 
PPNs. Depending on the patient, this targeted approach may also offer the best opportunity to 
preserve as much remaining lung function as possible in cases where subjects have respiratory 
comorbidities. Thus, developing and describing a streamlined, reproducible and accurate 
approach to nodule localization is a method that holds promise for thoracic surgeons. 
 
Current recommendations from the American College of Chest Physicians (ACCP) evidence- 
based guidelines for the management of pulmonary nodules begin with examination of the 
nodule, and an estimation of the clinical probability that the nodule is malignant and evaluation 
of surgical risk. For subjects with a high probability of cancer (>60%), diagnosis by biopsy and 
resection are recommended. More than 40% of lung targets are not accessible by conventional 
bronchoscopy due to their location, with contributing factors including the small diameter of the 
airways, lack of an airway leading to a nodule and maneuverability difficulties (Rivera et al, 
2003; Alberts and Colice, 2003). 
The ability to identify and to obtain diagnostic tissue from PPNs has been evaluated in clinical 
trials using techniques such as diagnostic bronchoscopy alone, and then in comparison, with 
EMN-guided bronchoscopy and r-EBUS (Ost et al., 2016). A large, multicenter registry-based 
clinical effectiveness study (AQuIRE Registry) (ibid..). The AQuIRE registry had a primary 
objective to measure and identify the determinants of diagnostic yield for bronchoscopy in 
patients with peripheral lung lesions. Secondary outcomes included diagnostic yield of different 
sampling techniques, complications, and practice pattern variations. Subjects were enrolled at 15 
centers having 22 study physicians between 2009-2014, and the registry was funded by the 
CHEST organization. 

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Ost et al. reported unexpectedly low diagnostic yields for electromagnetic navigation. Regarding 
the low EMN rate, one AQuIRE principal investigator (PI) noted “more than 98% of the EMN 
cases were performed with a single system (Medtronic, Minneapolis, MN) that lacks additional 
capabilities, including TTNA under EMN guidance. Since the completion of enrollment in the 
AQuIRE study, newer EMN technologies have been developed and now allow for a navigational 
transthoracic approach.” 
• The AQuIRE registry had a primary objective to measure and identify the determinants 
of diagnostic yield for bronchoscopy in patients with peripheral lung lesions. Secondary 
outcomes included diagnostic yield of different sampling techniques, complications, and 
practice pattern variations. 
• The AQuIRE registry reported poor diagnostic yields for multiple modalities 
o Bronchoscopic alone: 53.7% 
o r-EBUS when used alone: 57% 
o EMN Yield when used alone was 38.5% (98% of cases were SuperDimension 
technology) 
Of these, 312 subjects in the trial underwent transbronchial biopsy. Using bronchoscopy alone, 
the diagnostic yield was reported as 63.7%. In earlier work, the average diagnostic yield for 
peripheral lung lesion biopsy performed with conventional flexible bronchoscopy was reported 
to be 69% for peripheral lesions greater than 20 mm and 33% for peripheral lesions less than 20 
mm, (Mazzone et al, 2002; Rivera et al, 2003; Schriebner and McCrory, 2003). 
 
Results from studies involving procedural guidance technologies such as electromagnetic 
navigation (EMN) and radial endobronchial ultrasound (radial EBUS) have also been reported 
(Ost et al., 2016). Diagnostic yield was reported at 57% with r-EBUS alone, 47.1% with EMN 
combined with r-EBUS. In another recent study published in the New England Journal of 
Medicine, a total of 639 subjects underwent bronchoscopy for suspected lung cancer and of those 
bronchoscopic examinations, 43% were nondiagnostic, including in 25% (120 of 487 subjects) in 
whom lung cancer was ultimately diagnosed.9 As a result of published yields showing an 
unacceptable yield for peripheral bronchoscopy, ACCP guidelines recommends that nodules 
without a CT-bronchus sign should be pursued with EMB-TTNA (Rivera et al, 2013). 
 
Veran’s novel electromagnetic system (EMN) bronchoscope and toolkit use the EMN field with 
several “Tip Tracked” nodule localization instruments, and a bronchoscope to generate three 
dimensional maps of lung tissue and airways. The “Tip Tracked” instruments display their 
location during the procedures. The generated maps provide continuous, “real-time” navigational 
tracking, identifying an efficient path to localizing nodules only a few millimeters along their 
longest axis. Providing the operator with assisted lung nodule localization and navigation have 
improved diagnostic yields. The system uses the recent chest CT scan image and combines it 
with the bronchoscope to align the subject’s body with the CT images. This allows for the 
construction of 3-D virtual bronchoscopy images and the ability to navigate throughout the lung 
with a CT-correlated roadmap. As the operator steers the bronchoscope, a real time distance to 
target is generated, that can be used for the precise localization of small lesions. 

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Localization of the peripheral nodules in the outer lung regions can be accomplished 
intraoperatively, just prior to surgical resection, with the same surgical staff who are performing 
the operation. This eliminates an additional step for the thoracic surgeon (or other oncology team 
member) and also for the subject, namely identifying and coordinating with persons from other 
departments who may typically place fiducial, hookwire, and microcoils as separate procedures, 
involving additional resources. In addition, the migration of these markers, and the need to verify 
their placement with an additional CT or other scan prior to surgery, are potentially steps that 
may be able to be streamlined. The overarching objective is to keep this localization and 
resection procedure within the hands of the principal investigator, and to quantify the percentage 
of subjects in whom the nodule is removed in the first resected specimen, procedure time, and 
nodule characteristics and procedure details and techniques. 
3. RATIONALE 
 
Veran Medical Technologies, Inc. is seeking to characterize the efficient localization and 
successful removal of PPNs aided by the technique of percutaneous localization within the 
operating room. This falls within the current practice for these subjects. However, the 
characterization and comparison of various localization techniques has not been reported 
prospectively in a large, multicenter approach. 
 
To realize this opportunity, further localization methodologies must be developed. Percutaneous 
nodule localization involves various factors. Nodular size and location (near the pleura) can both 
introduce challenges for unequivocal localization and complete removal. PPNs can be difficult to 
locate and access in order to mark them. It can be difficult to find the marked nodules, 
depending upon the location and how well the localization technique worked during the resection 
surgery. This registry will collect data regarding different techniques used by thoracic surgeons 
using a choice of localization materials (dye, hookwire etc.) and with electromagnetic navigation 
guidance using a transthoracic approach. Evidence from a multicenter, prospective registry trial 
on localization procedures will allow us to understand the best practices in the localization of 
PPNs that also minimizes risks in subjects who are typically are older, have comorbid lung 
disease, poor pre-surgical lung function and may have early stage lung cancer. 
 
Further, the study will allow us to describe the use of VERAN SPiN Thoracic Navigation 
System™ and percutaneous lung localization tools in a real-world thoracic surgery practice, 
including duration of localization procedure, duration of the resection procedure, and other data 
elements. 

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TABLE 1 – SCHEDULE OF EVENTS 
 
Procedures/Data Collection 
Baseline 
Visit 
Day 0 
Surgery 
Localization 
Procedure 
Nodule is correct size and suitable for percutaneous localization during 
surgical resection procedure. 
X 
X 
Subject meets Inclusion/Exclusion criteria review. 
X 
Subject is able and willing, and signs consent form. 
X 
Pregnancy test- urine or serum, for females of child-bearing potential. 
X 
X 
Socio-demographic information. 
X 
Pulmonary function test results 
X 
Brief Medical History, including previous cancer diagnoses, smoking, 
and treatment history. 
X 
Nodule hx, dx, characteristics if known. 
X 
Recent (0-15 days) CT scan available, or schedule CT scan to be used on 
day of surgery, prior to procedure. 
X 
X 
AEs and SAEs. 
X 
X 
Reason for discontinuation in study or withdrawal if applicable. 
 
All data generated from this study will be the exclusive property of Veran Medical Technologies, to be used with expressed 
permission only. 

 
Veran Medical Technologies, Inc. 
Percutaneous Registry: the PLOTS Study 
November 2, 2020 
Protocol/Study No.: VMT-01-003 
 
 
TABLE 2 – Registry Study Flow1 
 
 
 
 
 
 
 
0 
1 2 3… 
5 
 
Number of Days Following Surgery 
 
 
1 Surgery: Day 0 is when the subject has the CT scan, procedure of PPN Localization and also lung resection. 
2 The number of days a subject is hospitalized is per investigator practice. It is recorded as a data element. 
3 The actual day of discharge is per investigator’s practice. It is recorded as a data element. 
 
 
 
 
 
 
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Hospitalization2 
2-5 
Dayof Discharge3 
E 
n 
r 
o 
l 
l 
m 
e 
n 
t 
CT Scan1 
Localization1 
Lung 
Resection1 

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4. OBJECTIVES 
The registry is aimed at developing a high-quality set of data regarding the percutaneous 
localization of PPNs. The localization registry itself is nested within the subjects’ lung 
resection operation. Analyzing and promulgating evidence-based best practices for lung 
nodule localization will allow surgeons to identify technical solutions and reproducible 
methods. 
This registry will record procedural data for trained thoracic surgeons using the SPiN Thoracic 
Navigation System™ and tools. Diagnostic yield will measure successful localization of the 
lesion in the resected specimen. Localization-related safety events will be collected. 
4.1 Primary Objective: 
Successful percutaneous localization of PPN. 
To evaluate the accuracy of percutaneous nodule localization using the SPiN Thoracic 
Navigation System™ and its accessories, Veran will record the percentage of successful 
resections that result in the complete removal of the patient’s nodule, with a negative margin. 
The diagnostic yield is calculated as the percentage of patients who have intra-operative 
localizations resulting in complete removal of nodule, divided by the total number of evaluable 
subjects. Evaluable subjects are those who complete the localization procedure. 
Primary Objective: Successful percutaneous localization of PPN. 
This is defined as the percentage of subjects in whom the nodule is successfully localized and 
removed in the first resected specimen. A pathological specimen with clear margins will count 
as a successful localization. 
4.2 Safety Objective: 
Collect safety data for localization procedure. 
4.3 Secondary Objectives: 
Secondary Objectives: Use as per synopsis – including margin. 
4.3.1 Report localization methods and techniques – dye and materials used, volume of dye 
(methylene blue, ICG etc.), other materials such as microcoils, hook wires etc. Details 
regarding these techniques will be collected. 
4.3.2 Collect data on intraoperative percutaneous localization time and duration of total 
surgical procedure. 
4.3.3 Record nodule characteristics, including location in the lobe, distance from pleura, 
distance from surface of skin to target, morphological appearance, solid vs. ground 
glass etc. 
4.3.4 Record weight of excised tissue and margin. 
4.3.5 Report type of surgical resection performed (segmentectomy or wedge) and resection 
technique (VATS, RATS, thoracotomy). 

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5. SUMMARY OF REGISTRY DESIGN 
 
PLOTS is a multicenter, post-approval study of the SPiN System™ in percutaneous 
localization. It’s an open-label registry study practically focused on the expedient 
intraoperative localization and removal of small pulmonary nodules in subjects undergoing 
lung nodule resection. The study will aim to collect data from 70-100 patients at approximately 
5 thoracic surgery sites distributed across the U.S. Each site is expected to enroll a minimum of 
6 subjects. Enrollment will be monitored and will stop once sufficient data has been collected. 
All post-surgical treatment decisions and clinical assessments will be at the discretion of the 
patient’s cardiothoracic surgeon or clinician per usual care, not be mandated by registry design. 
Please refer to Table 2 for a diagram of the study flow. 
6. DEVICE DESCRIPTION 
 
Definition of medical device: under 21 U.S.C. 321(h), a medical device is an instrument, 
apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or 
related article, including any component, part, or accessory, which is: 
• recognized in the official National Formulary, or the United States Pharmacopeia, or 
any supplement to them, 
• intended for use in the diagnosis of disease or other conditions, or in the cure, 
mitigation, treatment, or prevention of disease, in man or other animals, or 
• intended to affect the structure or any function of the body of man or other animals, and 
which does not achieve its primary intended purposes through chemical action within 
or on the body of man or other animals and which is not dependent upon being 
metabolized for the achievement of its primary intended purposes. 
The SPiN System is designed to help guide the physician with electromagnetic navigation 
while using a bronchoscope to help visualize nodules, and a transthoracic needle to reach 
nodules in a single procedure setting. Veran System components include an electromagnetic 
field generator, a locatable sensor probe that allows navigation through the bronchi/chest wall 
and computer software that creates virtual images for procedural guidance. 
In this study, the Veran System and sampling instruments will be used according to the 
associated Instructions for Use (IFU) (Appendix A) and in accordance with approved product 
labeling. The SPiN System utilized in this study will have SPiN Drive and SPiN Planning 
software version 4.0 or higher. Minor software updates are allowed if performed at all study 
sites within a reasonable timeframe. Under this circumstance, appropriate Investigator/site 
training must follow a software update and must also be noted in each investigator’s study 
binder. 

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6.1 Materials Used 
Veran Medical Technologies manufactured medical devices used in this study are SPiN 
Thoracic Navigation System™ with an assortment of needles having guidewires, SPiN Perc™ 
kit, and introducer and localization needles. 
 
Table 6.1 
Device Name 
SPiN Thoracic Navigation System™ 
and tools 
Type 
Medical Device 
Device Level 
II 
Status 
Approved Medical Device 
Procedural 
Registry 
Refinement of localization technique 
Sourcing 
Veran Medical Technologies 
Current/Former 
Name(s) or 
Alias(es) 
Veran Medical Technologies Aliases 
 
1. The Veran SPiN Thoracic Navigation System™ and SPiN Perc™ Kit were cleared to 
market by the U.S. Food and Drug Agency (FDA) under 510(k) (K170023). 
2. 510(K) Number K122106 Device Name. SPIN DRIVE ALWAYS-ON TIP TRACKED 
STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP 
TRACKED ASPIRATION NEEDLE. 
3. Please find the instructions for use and the package labeling in Appendix A. 
4. Transthoracic training and usage of the needles and System were covered in didactic, peer- 
to-peer, site initiation visit, and cadaver course trainings. 
 
AOTT Localization Needles (Thoracic) 
INS 5610 
SPiN Perc™ Localization Needle 19 gu x 105mm with 1cm marking zone. 
INS 5611 
SPiN Perc™ Localization Needle 10 gu x 105mm with 2cm marking zone. 
SPiN Perc™ Kits 
INS-5600 
SPiNPerc™ Biopsy Needle Guide Kit (Includes INS 5029). 
INS 5620 
SPiNPerc™ Biospy Needle Guide Kit (20 cm). 
 
SPiN System and Components 
SYS-0185 
SPiN Planning Laptop. 
SYS-1500 
SPiN View System. 
SYS-3000 
IG4 System. 
SYS-4000 
SPiN Thoracic Navigation System 120 volts 60 hz (US). 

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6.2 Other Medical Devices 
Devices (not manufactured by or for Veran Medical Technologies) used in this study are 
expected to include 1cc – 3cc Luer lock syringes, Olympus MP-160 or BF-190 bronchoscope, 
and microcoils and fiducials. 
6.3 Instructions for Use 
Instructions for use of the medical device are provided (Appendix A). All device deficiencies 
(including malfunction, use error and inadequate labeling) shall be documented and reported 
by the investigator throughout the clinical investigation, following the instructions and form 
found in section Appendix C. 
7. PRIOR CLINICAL DATA 
 
Current recommendations from the American College of Chest Physicians (ACCP) evidence- 
based guidelines for the management of pulmonary nodules begin with examination of the 
nodule, and an estimation of the clinical probability that the nodule is malignant and evaluation 
of surgical risk. For subjects with a high probability of cancer (>60%), diagnosis by biopsy and 
resection are recommended. More than 40% of lung targets are not accessible by conventional 
bronchoscopy due to their location, with contributing factors including the small diameter of 
the airways, lack of an airway leading to a nodule and maneuverability difficulties (Rivera et 
al, 2003; Alberts and Colice, 2003). 
The ability to identify and to obtain diagnostic tissue from PPNs has been evaluated in various 
clinical trials using a variety of techniques. The results over time are variable and do warrant 
further investigation. Techniques such as diagnostic bronchoscopy alone, and then in 
comparison with EMN-guided bronchoscopy, EMN-TTNA, and r-EBUS were studied in the 
large, multicenter registry-based clinical effectiveness study (AQuIRE Registry) (ibid..). The 
AQuIRE registry had a primary objective to measure and identify the determinants of 
diagnostic yield for bronchoscopy in patients with peripheral lung lesions. Secondary outcomes 
included diagnostic yield of different sampling techniques, complications, and practice pattern 
variations. Subjects were enrolled at 15 centers having 22 study physicians between 2009- 
2014, and the registry was funded by the CHEST organization. 
Ost et al. reported unexpectedly low diagnostic yields for electromagnetic navigation. 
Regarding the low EMN rate, one AQuIRE PI noted (Semaan R.W., 2016): 
“…more than 98% of the EMN cases were performed with a single system (Medtronic, 
Minneapolis, MN) that lacks additional capabilities, including TTNA under EMN 
guidance. Since the completion of enrollment in the AQuIRE study, newer EMN 
technologies have been developed and now allow for a navigational transthoracic 
approach.” 

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Ost replied in response that: “In such a scenario, the real question is not whether sensitivity 
will improve but, rather, by how much sensitivity will improve, and whether that improvement 
is worth the attendant increase in risk.” 
Acknowledging the Hopkins observation that that SD was used in almost all EMN cases, Ost 
writes: 
“They point out correctly that 98% of the cases in the AQuIRE registry were performed 
with SuperDimension (Medtronic, Minneapolis, MN). I concur that not all EMN 
systems are the same. There are substantive differences in the imaging and algorithms 
used between these two systems. Veran uses both inspiratory and expiratory films, 
whereas SuperDimension does not. Respiratory motion can affect nodule location 
significantly (2). The data in the AQuIRE registry do not provide insight into how 
Veran might perform in terms of bronchoscopic yield. On the basis of the difference 
between EMN systems, I agree that separate studies for the Veran system are 
warranted. “ 
As these (AQuIRE) were percutaneous cases using early EMN-guidance, the results of this 
registry may likewise provide insight into impacts of technological advances. The AQuIRE 
registry had a primary objective to measure and identify the determinants of diagnostic yield 
for bronchoscopy in patients with peripheral lung lesions. Secondary outcomes included 
diagnostic yield of different sampling techniques, complications, and practice pattern 
variations. 
• The AQuIRE registry reported poor diagnostic yields for multiple modalities 
o Bronchoscopic alone: 53.7% 
o r-EBUS when used alone: 57% 
o EMN Yield when used alone was 38.5% (98% of cases were SuperDimension 
technology) 
Of these, 312 subjects in the trial underwent transbronchial biopsy. Using bronchoscopy alone, 
the diagnostic yield was reported as 63.7%. In earlier work, the average diagnostic yield for 
peripheral lung lesion biopsy performed with conventional flexible bronchoscopy was reported 
to be 69% for peripheral lesions greater than 20 mm and 33% for peripheral lesions less than 
20 mm, (Mazzone et al, 2002; Riveria et al, 2003; Schriebner and McCrory, 2003). 
Results from studies involving procedural guidance technologies such as electromagnetic 
navigation (EMN) and radial endobronchial ultrasound (radial EBUS) have also been reported 
(Ost et al., 2016). Diagnostic yield was reported at 57% with r-EBUS alone, 47.1% with EMN 
combined with r-EBUS. In another recent study published in the New England Journal of 
Medicine, a total of 639 subjects underwent bronchoscopy for suspected lung cancer and of 
those bronchoscopic examinations, 43% were nondiagnostic, including in 25% (120 of 487 
subjects) in whom lung cancer was ultimately diagnosed (Silvestri et al, 2014). As a result of 
published yields showing an unacceptable yield for peripheral bronchoscopy, ACCP guidelines 
recommends that nodules without a CT-bronchus sign should be pursued with EMB-TTNA 
(Rivera et al, 2013). 

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A prospective, single center pilot study evaluated the safety, feasibility, and diagnostic yield of 
staged approached for taking biopsy samples in a single procedure setting (Yarmus LB et al., 
2016). In this study, enrolled subjects (n=24) underwent EBUS for lymph node staging, 
followed by EMN-bronchoscopy, and EMN-TTNA. The researchers report a diagnostic yield 
of 83% for EMN-TTNA alone, and 87% when combined with EMN-bronchoscopy. The 
diagnostic yield increased to 92% when combined with EBUS. There were five (21%) 
pneumothoraces of which two (8%) required chest tube placement. No bleeding events were 
observed. The researchers conclude that the results demonstrate an acceptable safety and 
feasibility profile. 
8. RISKS AND BENEFITS 
PLOTS is a registry documenting small lung nodule localization techniques used by thoracic 
surgeons for patients just prior to lung resection. The localization PPNs with dye injection 
and/or microcoils is a standard medical procedure physicians complete prior to the resection 
procedure. All procedures represent the clinical standard of care provided by thoracic surgeons 
to their patients. The following section documents the risks and benefits of Registry 
participation, as well as the published clinical rates of complications as they are known. 
 
The risks associated with the localization procedure are noted, as well as the use of the device. 
If approved devices will be used as part of the research, each site may be asked to confirm that 
the device(s) they are using are being used within their approved labeling 
 
The SPiN Thoracic Navigation System™ and its accessories are marketed for use as tools in 
the diagnosis and treatment of lung cancer. All devices used in this study are commercially 
available and there are no anticipated risks beyond those already associated with early lung 
cancer diagnosis and surgical treatment procedures in clinical practice. 
 
Data, including safety data, will be collected from each subject’s nodule localization 
procedure. The surgical procedure is not experimental in this 510(k)-marketed device that is 
being used within its approved labeling. Safety data will be summarized and reported from the 
localization procedure. 
8.1 Registry Data Collection – Risks and Benefits 
Registry Risks: Every effort will be made to protect the privacy of research subjects. Subject 
names and protected health information (PHI) will be kept confidential to the extent possible 
and as required by HIPAA. All records and data related to the study will be maintained in a 
secure protected space, with access restricted to study personnel or individuals designated by 
study personnel who (i) need access to the information to fulfill the terms and obligations of 
the Coordinating Site or the Sponsor under the Protocol and (ii) are under the same obligations 
as study personnel to keep the information confidential. It is an open-label study, and each 
study site will use its own portal only. There are software firewalls in place to prevent site 
personnel from seeing data from other investigative sites. 

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Registry Benefits: Subjects will not receive any direct benefit as a result of their participation 
in the registry. However, information contained within the registry will be used for research 
studies directed at improving our knowledge and treatment of very early lung cancer diagnosis, 
screening, and treatment. Identifying best practices for use in small nodule localization may 
benefit patients with early lung cancer in the future. 
8.2 Procedural Data Collection – Risks and Benefits 
Procedure-Related Benefits 
The Veran ENB SPiN Thoracic Navigation System™ for lung cancer and the SPiN Perc™ Kit 
(Veran System) were cleared to market by the U.S. Food and Drug Agency (FDA) under 
510(k) (K170023). The Veran System is designed to help guide the surgeon with 
electromagnetic navigation while manipulating small pulmonary nodules. Early detection (and 
removal) of lung cancer relies upon the precise identification and prompt removal of 
pulmonary nodules. Deep pulmonary nodules represent a particular technical challenge for 
surgeons, due to their accessibility. SPiN System biopsy tools are capable of integrating 
information from imaging devices into real-time visualization, allowing for targeted 
percutaneous localization of small PPN’s. Optimization of this technical localization 
procedure may result in more accurate identification of small tumors in lung tissue, when used 
by a skilled, trained surgeon or physician. 
Procedure-Related Risks 
Reported radiation exposures to the patient from the low dose helical CT procedure are comparable 
to current practice. No additional procedural risks are anticipated to be introduced. 
8.2.1 Anesthesia – Lung Resection Procedure 
Sedation and the act of passing a bronchoscope into the airway introduce medical risks. Older 
adults, or those with serious medical problems, particularly those undergoing more extensive 
procedures, may be at increased risk of postoperative confusion, pneumonia, or even stroke 
and heart attack. To mitigate the risks of anesthesia, anesthesiologists or anesthesiology nurses 
and/or a respiratory therapist typically monitor all patients during the procedure per their 
institutional protocols and training. In addition, oxygen saturation (using pulse oximetry), 
respiratory rate, blood pressure, ECG, and heart rate are typically continuously monitored. 
Patients are not released until they are fully awake and medically stable. 
The benefits of anesthesia are that subjects will not feel or remember the pain of the surgical 
procedure. 
8.2.2 Bronchoscopy – Lung Resection Procedure 
 
The greatest risks from bronchoscopy, used as a step to align (“register”) the subject’s day of 
surgery CT with the subject’s current position on the surgical table, are related to sedation and 
to the act of passing a bronchoscope into the airway. To mitigate the risks of bronchoscopy, 
subjects will be under general anesthesia. Subjects are typically monitored during this 

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procedure. In addition, oxygen saturation (using pulse oximetry), respiratory rate, blood 
pressure, ECG, and heart rate are continuously monitored. Patients are typically hospitalized 
following lung surgery for approximately days in the US and released when medically stable. 
8.2.3 Trans-thoracic Nodule Localization – Registry Procedure 
The risks associated with trans-thoracic nodule localization are bleeding and pneumothorax, 
The measures to mitigate the risks are the same for all surgical procedures. Patients are given 
supplemental oxygen and their oxygen level is continuously monitored using pulse oximetry. 
A nurse or physician continuously monitor patients’ ECG, heart rate, blood pressure, and blood 
oxygen during the procedure. 
9. RESEARCH METHODS AND DATA COLLECTION 
 
In this study, the “lung resection and after care protocol” is determined by each investigator’s 
current practice, with an outline provided in the registry to explain the context for the type of 
data collection performed in this patient population. The medical device is being marketed for 
and used within its intended use. 
 
Localization methods and outcomes, and data related to the nodules, diagnosis, and the setting 
of the planned clinical intervention of nodule removal will be recorded. Data will be collected 
according to descriptions below, Table 1 and Figure 1. 
 
Collected data include brief medical history, smoking history, demographic characteristics, 
radiographic characteristics, procedural characteristics, crossover to other procedures, and 
adverse events, as follows: 
 
• 
Radiographic Characteristics: 
The location of the target nodule (side, lobe and segment, i.e. right upper lobe anterior 
segment, etc.) will be determined and recorded. The radiographic information collected 
from CT will include size of the nodule (longest axis), distance from a visible bronchus, 
and distance from the pleural surface perpendicular to the nodule. 
 
 
• 
Procedural Characteristics: 
Collected procedural information will include the distance of target from pleura nodule 
statistics (volume, RESIST diameter, maximum, minimum, and effective diameter), 
and target motion. The duration of the localization procedure will also be recorded. 
 
• 
Crossover to Other Procedures: 

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All procedures performed to aid in the surgical management of patients – will be noted. 
Wedge resection, segmentectomy, and lobectomy. The type of initial surgery planned, 
and the eventual surgery done, will both be collected. 
• 
Adverse Events: 
All device and/or procedure related adverse events will be recorded for the study 
localization procedure. Events will be collected from the initiation of the localization 
procedure to the start of the wedge resection procedure. Study sites will report 
localization-related adverse events and complications to their IRBs according to 
institutional requirements. These will be recorded. 
9.2 Primary Efficacy Objective: Successful Percutaneous Localization of PPN 
This is defined as the percentage of subjects in whom the nodule is successfully localized and 
removed in the first resected specimen. A pathological specimen with clear margins will count 
as a successful localization. 
To evaluate the accuracy of percutaneous nodule localization using the SPiN Thoracic 
Navigation System™ and its accessories, by recording the percentage of successful nodule 
resections that result in the complete removal of the patient’s nodule, with at least a one cell 
perimeter and negative margins. The diagnostic yield is calculated as the percentage of patients 
who have intra-operative localizations resulting in complete removal of nodule, divided by the 
total number of evaluable subjects. 
 
Confirmation of Diagnosis 
Surgical pathology results will determine the outcome of the primary endpoint. If the patient 
has follow-up imaging that shows a decrease in size or resolution of the nodule, the nodule will 
be determined to be of benign etiology if the study pathology yields a benign diagnosis 
(granuloma, inflammation, fibrosis, infection). To verify final diagnosis, a copy of the final 
pathology report will be de-identified and provided by the site. The pathology findings will 
then identify the case as either benign or malignant. Whether a benign or malignant diagnosis 
is made, the primary endpoint is met. 
 
If Margins are Intact 
If the nodule has intact margins as described by the pathology report. Explicitly, a perimeter of 
at least one cell around the nodule contain cells that are all non-malignant. This plus the 
nodule sample verifies that the entire nodule was removed. The pathology findings will then 
identify the case as either benign or malignant. 
 
Crossover Cases 
It is anticipated that there will be cases where the wedge is positive for malignancy and the 
deep margin also will be positive. In these cases, the surgical plan may change from a planned 
wedgectomy into a completion lobectomy or segmentectomy. If the nodule is fully removed 

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(having at least a cell’s margin of non-malignant cells in these cases, then the primary endpoint 
is met. The pathology findings will then identify the entire case as either benign or malignant, 
and the primary endpoint is met. 
 
Margins for Crossover Cases 
If the nodule is fully removed in crossover cases, then the primary endpoint is met. The nodule 
may be removed per the surgeon’s judgement. The pathology findings will then identify the 
entire case as either benign or malignant, and the primary endpoint is met. 
 
If Diagnosis is Non-malignant 
If the nodule is deemed non-malignant, cells are identifiable, then the positive box for 
diagnosis is checked, and: 
• 
The nodule must have an intact margin of a cell as a perimeter to be diagnostic. 
• 
The type of nodule (ground glass opacity, etc.) is collected from the pathology report. 
The pathology findings will then identify the case as either benign or malignant. 
 
9.3 Safety Objective: 
Record Safety Events During Intraoperative Percutaneous Localization Only 
To collect and evaluate the safety of nodule localization, including incidence and severity of 
localization-procedure related adverse events (AEs) and serious adverse events (SAEs) that 
occur during the localization procedure. 
 
Baseline/Enrollment 
All patients will be provided with information about the registry and will sign the informed 
consent form before any registry-related assessments are made. The following data will be 
collected at baseline for all enrolled patients: 
 
• 
To be collected at baseline visit: Review of inclusion/exclusion criteria. 
 
Localization Period 
• The localization period begins when the needle touches the subject’s skin. 
• Localization ends when the localization needle is withdrawn from the subject for the 
final time. 
• Any adverse events that develop during the localization procedure will be reported. 
• Bronchoscopy-related events that occur during the alignment of the CT with the patient 
(“registration”) will be recorded. 
• Percutaneous localization step, injection of dye, injection of any microcoils, etc. 
 
The process used for AE reporting conforms to Veran Medical Technologies, Inc., standard 
operating procedures (SOPs) for Medical Device Reporting (MDR)(Appendix C). Training on 
AE/SAE/MDR reporting practices will be provided to each participating site. 

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9.3 Subject Enrolment and Informed Consent 
Patients presenting to their physician in need of assessment or removal of peripheral 
pulmonary nodule(s), and who meet study inclusion/exclusion criteria, will be invited to 
participate. Patient enrolment will follow each participating institution’s standard of care. 
Subjects will be approached to obtain informed consent prior to any study-specific procedure. 
Informed consent will take place in a private environment (e.g. patient exam room), free from 
distractions. The PI or study team member will approach the subject at their clinic appointment 
and will explain the study to qualified subjects prior to obtaining consent. All individuals who 
obtain consent (PI, Sub-investigators, and study coordinators) must have received GCP 
informed consent training within the past 2 years. Interviews to obtain consent will not follow 
any stressful situation (e.g. patient being informed he/she may have cancer) and will not be 
conducted if the patient has received any mind-altering medications or anesthesia. Patients will 
be assessed for their capacity to consent by the ability to show comprehension of the 
procedure, ask appropriate questions, and appear properly oriented. 
 
The PI will confirm subject eligibility. Patients who sign the informed consent form will be 
considered enrolled. A signed copy of all consents and the HIPAA authorization document will 
also be given to consenting subjects. 
 
Patients who complete the localization procedure will be included within the analysis 
population. Reasons for study withdrawal will be recorded. Each patient’s participation in this 
study is approximately 6 weeks baseline through subject’s discharge from hospital following 
lung surgery. 
9.4 Withdrawal of Subjects 
Following informed consent, subjects withdrawn from the study prior to the localization 
procedure due to patient withdrawal of consent or at the discretion of the investigator will be 
considered withdrawn. In the case of investigator withdrawal, the reason for early withdrawal 
will be documented. Data collected from all treated patients undergoing localization will be 
included within the analysis population. 
9.5 Screen Failures 
Subjects who provide informed consent but are determined to be ineligible prior to the index 
procedure will be considered screen failures. The reason for screen failure will be documented. 
The assigned subject ID for the subject will not be re-used. 
9.6 Pre-procedure Chest CT Scan Evaluation 
After informed consent is obtained, the patient’s most recent chest CT scan or chest x-ray will 
be deidentified and securely downloaded and saved. If subjects have multiple pulmonary 
nodules, the site PI will identify the target nodule. 

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9.7 Non-contrast Chest CT 
It is recommended by the manufacturer that the subject receives a non-contrast chest CT scan 
be performed on the same day as the procedure as a clinically indicated procedural planning 
tool (Veran Appendix B – technical description of CT parameters). Otherwise, a chest CT scan 
from within the past 15 days may also be used when it is consistent with these parameters. 
 
9.8 General Anesthesia 
Patients will undergo the procedure under general anesthesia. 
 
9.9 Nodule Localization 
The bronchoscope (Olympus MP-160 or BF-190) will be introduced into the airway. A Veran 
tip tracked instrument will then be introduced into the working channel of the bronchoscope 
and utilizing standard Veran System navigation-matching protocols, the main and secondary 
carinas are identified using the tip tracked instrument to confirm that the Veran System is 
properly matched to the airway defined by accurate matching of the main and secondary 
carina. This allows the system to align the CT with the patient’s current position. 
Following registration, a sterile field is created on the chest wall as identified by the Spin Perc 
planning software and the area is prepped and draped. A tip tracked needle, such as one of the 
Veran localization needles or the Veran tip tracked Spin Perc needle introducer, is selected. 
The surgeon advances the needle trans thoracically into the nodule, under Veran EMN 
guidance, to the nodule. The nodule is localized percutaneously by marking with dye using an 
assortment of tools designed for this purpose (Section 5.1), adding microcoils or fiducials, etc. 
 
Data Collected: patient position, registration, volume of dye, type of dye, use of microcoils or 
fiducials. 
 
The surgeon then continues to wedge resection, and the registry portion of the procedure is 
completed. 
 
 
9.10 Study Discontinuation 
The following data will be recorded as available from any enrolled subjects who withdrew 
consent during the Registry: 
• SAEs/AEs - Method of treatment, severity, etc. 
• Concomitant medications including dosages 
• Reason for withdrawal 

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10. COMPLAINT AND SAFETY REPORTING 
Principal Investigators were taught to use FDA 3500A MedWatch (Appendix C) and were 
taught to fill those out during the investigator meeting, for relevant SAEs and also for medical 
device complaints. This registry’s primary safety objective is to collect localization-related 
safety events in patients undergoing wedgectomy. 
The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory 
requirements for device user facilities (including hospitals, surgical facilities and other) to 
report certain device-related serious adverse events and product problems to the FDA. These 
are described in further detail below. 
• User facilities must report a suspected medical device-related death to both the FDA 
and the manufacturer within 10 days. 
• User facilities must also report a medical device-related serious injury to the 
manufacturer (Veran Medical Technologies, address below). 
• In addition, each IRB and institution may have its own policies regarding the content, 
format, and timing for the reporting of SAE information. 
Each investigator is responsible for fulfilling these duties. Please report device serious adverse 
events to Veran as noted below on form 3500A (Appendix C): 
Email: vsupport@veranmedical.com 
Email: plots@veranmedical.com 
 
10.1 Complaint Reporting 
A device deficiency is an inadequacy of a medical device related to its identity (e.g. labeling), 
quality, durability, reliability, safety or performance, such as malfunction. It can also include a 
broken needle. It is important to Veran Medical Technologies to be aware of and remedy any 
device deficiencies. Please submit complaints or product problems to Veran Medical 
Technologies, using form 3500A (Appendix C). 
 
User facilities are not required to report a device malfunction to the FDA. They can 
voluntarily inform the Agency of such product problems through MedWatch, using form 
3500A (Appendix C). 
 
Please report device deficiencies to Veran as noted below on form 3500A: 
Email: vsupport@veranmedical.com 
Email: plots@veranmedical.com 
10.2 Safety Reporting 
All SAEs and device deficiencies related to the Veran system or its instruments are also to be 
reported directly to Veran as follows: (please send to vSupport, and Cc: the PLOTS email) 
Email: vsupport@veranmedical.com 

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Email: plots@veranmedical.com 
 
For any FDA-reportable event, please also forward to the following for awareness: 
Contact: Nathan Hunt 
Phone: 
(314) 334-5363 
Email: 
Nathan.Hunt@veranmedical.com 
 
Safety events from the localization procedure only will be collected in the registry 
(please refer to Appendix B for all data elements collected in Registry). 
 
This study is being conducted under 21 CFR part 501 (https://www.ecfr.gov/cgi- 
bin/textidx?SID=244dabc113521b0a851a5db147554fdd&mc=true&node=pt21.1.50&r 
gn=div5) using a 510(k)-cleared device system. The exemption in 21 CFR 812.2(c)(2) 
applies to this study, where the device is substantially equivalent to its predicate, and 
the device is being used in accordance with its labeling. 
 
Study sites are likewise responsible to report adverse events and complications to their 
IRBs according to institutional requirements. 
 
10.3 Adverse Events – Data Collection for Localization Events 
An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, users or other 
persons, whether or not related to the investigational medical device. Note: Pre-existing 
conditions are not considered to be adverse events unless there is a change in the nature or 
severity of the condition. 
 
We will collect data on the localization adverse event through subject discharge from hospital. 
Principal Investigators were taught to use FDA 3500A MedWatch (Appendix C) and were 
taught to fill those out during the investigator meeting, for relevant SAEs and also for medical 
device complaints. This registry’s primary safety objective is to collect localization-related 
safety events in patients undergoing localization prior to wedgectomy. 
 
The Medical Device Reporting (MDR) regulation (21 CFR 803) contains mandatory 
requirements for device user facilities (including hospitals, surgical facilities and other) to 
report certain device-related serious adverse events and product problems to the FDA. These 
are described in the forms in Appendix C, and the FDA’s Guidance for User Facilities. 
• User facilities must report a suspected medical device-related death to both the FDA 
and the manufacturer within 10 days. 
• User facilities must also report a medical device-related serious injury to the 
manufacturer (Veran Medical Technologies, address below). 
• In addition, each IRB and institution may have its own policies regarding the content, 
format, and timing for the reporting of safety information. 
 
1 The Electronic Code of Federal Regulations (www.ecfr.gov) - https://www.ecfr.gov/cgi-bin/text 
idx?SID=244dabc113521b0a851a5db147554fdd&mc=true&node=pt21.1.50&rgn=div5 accessed 4/16/2019. 

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Each investigator or delegate is responsible for fulfilling these duties. 
Please report device serious adverse events to Veran as noted below on form 3500A 
(Appendix C). 
Please scan and send completed forms to: 
Email: vsupport@veranmedical.com 
Email: plots@veranmedical.com 
 
10.3.1 Serious Adverse Event 
A serious adverse event (SAE) is an adverse event that has: 
1. Led to death, 
2. Led to serious deterioration in the health of the subject, that either resulted in: 
• a life-threatening illness or injury, or 
• a permanent impairment of a body structure, or 
• in-patient or prolonged hospitalization, or 
• medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
3. Led to fetal distress, fetal death or a congenital abnormality or birth defect. 
 
Note: Planned hospitalization for a pre-existing condition, or a procedure required by 
the study, without serious health deterioration is not considered a SAE. 
 
10.4 Causality – Adverse Event Relationship 
The PI will assess the relationship of an adverse event to the device and procedure as 
follows: 
• 
Not Related: No relationship appears to exist between the AE and the 
device and/or procedure. 
• 
Related: The AE follows a plausible temporal sequence following 
administration of the study device and/or execution of the procedure. 
• 
Undetermined: It is not possible to determine the relationship of the AE 
with the study device and/or procedure. 
 
10.5 Adverse Event Outcome 
The outcome of AEs will be recorded as follows: 
 
• 
Resolved: The event is considered fully resolved. 
• 
Continuing: At study exit the event is considered ongoing. 
 
Note: Any unresolved AE ongoing past study exit will be monitored by the physician 
per institutional standard of care. 

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10.6 ADVERSE EVENT RECORDING 
AEs will be documented in the applicable source documentation (i.e. medical record). 
Study data collection forms should capture the event diagnosis as opposed to symptoms 
(e.g. Infection vs. fever). The adverse events of pneumothorax and bronchopulmonary 
hemorrhage (including hemoptysis) will be documented as follows: 
 
• Hemorrhage: Significant bronchopulmonary hemorrhage including hemoptysis 
will be defined as bleeding noted at the time of procedure that requires a change 
in the level of care (e.g. outpatient to inpatient or inpatient to ICU) or a blood 
transfusion or separate intervention (i.e. surgery or embolization). Severity will 
be classified according to CTCAE as follows: 
o 
Grade 1: Mild symptoms; intervention not indicated 
o 
Grade 2: Moderate symptoms; medical intervention indicated 
o 
Grade 3: Transfusion, radiologic, endoscopic, or operative intervention 
indicated (e.g. hemostasis of bleeding site) 
o 
Grade 4: Life-threatening respiratory or hemodynamic compromise; 
intubation or urgent intervention indicated 
o 
Grade 5: Death 
11. STATISTICAL METHODS 
 
11.1 Sample Size 
This is an observational study where no formal hypothesis is being tested, data 
collected during the study will be summarized using descriptive statistics. No formal 
sample size estimations were utilized to determine the size of the study population. 
Generally, demographic and other descriptive characteristics of the cohorts will be 
described as counts and percentages for categorical variables and as measures of central 
tendency (mean, median, standard deviation [SD], and range) for continuous variables. 
Ninety-five percent (95%) confidence intervals will be computed for measures of effect 
and association. In some cases, data may be summarized by demographic. 
The study will have 70-100 evaluable patients from approximately 5 sites in the US 
who undergo percutaneous localization followed by surgical resection. Evaluable 
patients are those who undergo the percutaneous nodule localization procedure and 
meet the inclusion/exclusion criteria. Each site will be expected to enroll a minimum of 
6 subjects at their site. 
11.2 Data Analyses 
11.2.1 General Considerations 
The analysis to be performed will be described in a written and approved statistical 
analysis plan (SAP). No adjustments will be made for multiple comparisons. 
Effectiveness data will be summarized. Serious adverse events (SAEs) and adverse 

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events will be listed and summarized. Data collected during the study will be uploaded 
at the sites into Medrio and summarized and analyzed at least bi-annually. 
All AE and Medical History verbatim terms will be recorded and coded using the 
CTCAE criteria. 
11.2.2 Handling of Missing Data 
The proportion of missing data will be reported for each measured variable in the study. 
12. STUDY MANAGEMENT 
 
12.1 Overall Study Management 
• Regulatory Considerations: The SPiN System and tools are a medical 
device that is 510(k) exempt under 21 CFR 812.2(c)(2), which applies to 
the investigation. The 510(k) product is being used in accordance with 
the product labeling (Appendix A). 
• Subject Protection: 21 CFR part 50; 45 CFR part 46 
• Patient Privacy: HIPAA 
• IRB Approval: 21 CFR part 56 
• Good Clinical Practices: 21 CFR part 11; 21 CFR part 812 
• Site Monitoring: Veran Medical Systems 
• MDR: 21 CFR part 803 
 
Investigators will be selected on the basis of their experience, training, and education. 
The sponsor will provide the final protocol and coordinate the review, dissemination, 
and approval of protocol amendments (if any). The sponsor will develop the study 
database and define the data collection process. Sponsor staff will collect and maintain 
study-related documents from participating sites (e.g. Protocol signature page, training 
documents, IRB approval, etc.) to create a sponsor’s study file. The sponsor will 
develop consent form template with the expertise of study investigators, provide IRB 
submission assistance if required, and confirm IRB approval prior to subject 
enrollment. 
 
Likewise, the sponsor will: 
• Provide routine monitoring of data and protocol deviations as 
collected; 
• Disseminate information to sites and IRBs as appropriate. 
• Schedule routine meetings (e.g. teleconferences) with 
participating sites and develop monthly progress reports. 
• Provide study-specific training for staff at participating sites. 
• Perform periodic site visits to assess protocol adherence. 

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An executive steering committee will determine the schedule and quantity of 
publications and will routinely review data from the registry. 
 
Electronic Data Capture 
All data will be collected and entered into the electronic data capture (EDC) system that 
Veran Medical Technologies has created specifically for this purpose (Medrio®). Sites 
will be responsible for entering extracted patient data into a secure internet-based EDC 
registry database via the eCRF. Investigators and site personnel will be able to access 
their secure, encrypted accounts with individual usernames and passwords. 
Participating sites will have access to their own enrolled subjects’ data only, with 
permissions assigned to trained study staff. All eCRFs should be completed by 
designated, trained personnel or the study coordinator, as appropriate. The eCRF should 
be reviewed, electronically signed, and dated by the Principal Investigator. All changes 
or corrections to eCRFs will be documented in an audit trail with an adequate 
explanation made to explain the reason for the change, a signature, and a time/date 
stamp. 
12.2 File Retention and Archiving 
To enable evaluations and/or audits from regulatory authorities or the Sponsor, the 
investigator agrees to keep records, including the identity of all participating patients, 
all original signed ICFs, copies of all case report forms (CRFs), SAE forms, site files, 
investigator information, source documents, and adequate documentation of relevant 
correspondence (e.g., letters, meeting minutes). The records should be retained with the 
study binder. 
Each site will receive a study site file at study initiation which contains all documents 
necessary for the conduct of the registry and is updated throughout the study. This file 
must be available for review in the event the site is selected for monitoring, audits, or 
inspections and must be safely archived for at least 5 years after completing 
participation in the study. Documents to be archived include site regulatory files 
including IRB approvals, the subject enrollment log and the signed ICFs. In the event 
that archiving of the file is no longer possible at the site, the site will be instructed to 
notify the Sponsor. 
If these files are filed electronically, they must follow electronic document archival 
practices, contain a backup file on the same media, and also the ability to read the files 
for 5 years. 
12.3 Data Management 
High data quality standards will be maintained, and processes and procedures will be 
utilized to ensure that the data are as clean and accurate as possible when presented for 

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analysis. Data quality will be enhanced through a series of programmed or manual data 
edit checks that automatically detect out-of-range or anomalous data. 
12.4 Changes to the Protocol 
Changes to the protocol will be documented in written protocol amendments. Major 
(i.e., substantial, significant) amendments will usually require submission to the 
relevant IRB for approval or favorable opinion. In such cases, the amendment will be 
implemented only after approval or favorable opinion has been obtained. 
Minor (non-substantial) protocol amendments, including administrative changes, will 
be filed at each participating site and will be submitted to the relevant IRB or regulatory 
authorities where required by pertinent regulations. Any amendment that could have an 
impact on the patient’s agreement to participate in the study requires the patient’s 
informed consent prior to continued participation in the study. 
12.5 Study Governance 
An executive steering committee of 4-6 members will be established, drawing from the 
investigators enrolling patients into this study. This committee, with the sponsor, will 
review the protocol and oversee the study design. The committee will also recommend 
meetings and topics for abstracts and papers to be submitted for presentation and 
publication. All investigators will have access to the data for their individual site; 
however, only the sponsor or its designee shall have access to the entire, multicenter 
data set. The ESC may review the de-identified data, for purposes of oversight and also 
for publication. Any requests for publication of individual site data will be submitted to 
the committee for review and consideration; the committee recommendation will be 
submitted to the company for consideration. 
All data generated from this study will be the exclusive property of Veran Medical 
Technologies, Inc. 
12.6 Publication Policy 
Any publication of the results from this study must be consistent with the Sponsor’s 
publication policy and guided by the Uniform Requirements for Manuscripts Submitted 
to Biomedical Journals: Writing and Editing for Biomedical Publication of the 
International Committee of Medical Journal Editors (ICMJE), updated April 2010 
(ICMJE 2010). The rights of the Investigator and of the Sponsor regarding publication 
of the results of this study/registry are described in the Investigator contract. 
13. PROTOCOL COMPLIANCE 
No amendments to the protocol are permitted without prior written approval from the 
Lead Investigator, Veran and the associated IRB. Deviations to the protocol are not 
allowed, except in the case of an emergency, or for the protection of the life or physical 

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well-being of the subject. Investigators are responsible for reporting all protocol 
deviations to Veran in writing as soon as reasonably practicable and to their IRB per the 
local reporting policy. Unless otherwise notified in writing, investigators shall provide a 
written report to Veran’s Director of Clinical Studies describing all protocol deviations 
in full and shall cooperate with Veran to provide any additional information upon 
request in a reasonable and timely manner. 
 
14. DATA STORAGE AND MAINTENANCE 
This study will utilize an electronic database. Prior to study initiation, the PI and staff 
will receive training to ensure that all personnel fully understand the protocol, data 
collection, and any other study related issues or documents. Data will be collected from 
patient’s charts, EHR, medical imaging, and the Veran System. The Registry database 
will belong to Veran Medical Technologies. 
 
Electronic Data will be entered and stored in the secure Medrio® database created for 
this study. Medrio® is a web-based application designed exclusively to support data 
capture for research studies. It provides an interface for data entry, audit trails, 
procedures for importing data from external sources, data features such as branching 
logic and calculated fields, and automated export procedures for data downloads to 
common statistical packages such as SAS. 
 
Each PI will review the collected study data, which will become part of the subject’s 
medical record and research record. Any clinical follow-up or repeat procedures will be 
dictated by the patient’s physician based on clinically relevant data and will not be 
influenced by enrollment into this study. 
 
To protect subject confidentiality, the data entry/portal tool will receive all patient data 
as de-identified through use of the study data codes. All information and data related to 
this study will be stored in a secured, locked cabinet at Veran Medical Technologies, 
and also at each investigator’s site. 
 
Access to this study data is restricted to the Sponsor and to study personnel alone, and 
controls include encryption and user-id and password-protected databases. 
 
Registry documentation and paperwork will be stored at each Principal Investigator’s 
site in a locked file cabinet. Registry records will be retained for 5 years after the 
completion of the registry. After that period of time, all individual patient information 
will be managed according to the policies of the PI’s institution. 

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15. ETHICAL AND REGULATORY CONSIDERATIONS 
 
15.1 Guiding Principles and Regulations 
To ensure the quality and integrity of research, this study will be conducted under Good 
Clinical Practices (GCPs) issued by the FDA. 
Specifically, the study will be conducted in compliance with: 
US FDA Title 21 CFR Part 50 – Protection of Human Subjects, and 
US FDA Title 21 CFR Part 56 – Institutional Review Boards; 
Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
US FDA Title 21 CFR Part 11 – Electronic Signatures. 
US FDA Title 21 CFR Part 803. 
US FDA Title 21 CFR 812; 21 CFR 812.2(c)(2) 510k Exempt Medical Device. 
IRB approval and informed consent is also required for research under 45 CFR 46. 
15.2 Site Required Documents 
In addition to the standard site qualification documents, prior to the enrollment of any 
patients in the study, the following documents must be provided by the site to the 
Sponsor (or their designee): 
• Copy of the IRB approval letter for the protocol and informed consent (all 
written information provided to the patient must be approved by the IRB) 
• Copy of the IRB-approved informed consent document to be used 
• Copy of the protocol sign-off page signed by the investigator 
• Fully executed site agreement (clinical trial agreement) 
 
This is a post-marketing study conducted within approved labeling for a marketed 
510K device (and not an experimental device). An investigator’s meeting and training 
sessions about localization techniques. A cadaver session was also held to practice 
localization techniques as part of the investigator’s meeting. 
15.3 Patient Information and Informed Consent 
An ICF must be signed by the patient before his or her participation in the study. The 
medical file for each patient should document the informed consent process and that 
written informed consent was obtained prior to participation in the study. A copy of 
each signed ICF must be provided to the patient. All signed and dated ICFs must 
remain in each patient’s study file and must be available for verification by study 
monitors at any time. 
The ICF should be revised whenever there are changes to procedures outlined in the 
informed consent or when new information becomes available that may affect the 

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willingness of the patient to participate. For any updated or revised ICFs, the medical 
file for each patient should document the informed consent process and that written 
informed consent was obtained for the updated/revised ICF for continued participation 
in the study. 
15.4 Patient Confidentiality 
In order to maintain patient confidentiality, each patient will be assigned a unique 
patient identifier upon study enrollment. This patient identifier will be used in place of 
patient name and or initials for the purpose of data analysis and reporting. Medical 
record number or other local reference identifiers are not collected as part of the 
database. All parties will ensure protection of patient personal data and will not include 
patient names on any study forms, reports, publications, or in any other disclosures, 
except where required by law. In accordance with local US regulations, patients will be 
informed about data handling procedures and asked for their consent. Data protection 
and privacy regulations will be observed in capturing, forwarding, processing, 
reporting, and storing patient data. Every effort will be made to protect participant 
confidentiality. 
The database will be housed at Medrio in a physically and 21 CFR part 11 logically 
secure computer system maintained Medrio with a written security policy. The system 
meets approved established standards for the security of health information and is 
validated. The system also meets the standards of the International Conference on 
Harmonisation (ICH) guideline E6R2 regarding electronic study data handling and is 
available for audit upon request. Patient confidentiality will be strictly maintained. 
15.5 Independent Ethics Committee/Institutional Review Board 
Consistent with local regulations and prior to enrollment of patients at a given site, the 
study protocol will be submitted together with its associated documents (e.g., ICF) to 
the responsible IRB for its review. Patient enrollment will not start at any site before 
the Sponsor has obtained written confirmation of a favorable opinion/approval from the 
relevant central or local IRB. The IRB will be asked to provide documentation of the 
date of the meeting at which the favorable opinion/approval was given that clearly 
identifies the study, the protocol version, and the ICF version reviewed. 
Before implementation of any substantial changes to the protocol, protocol amendments 
will also be submitted to the relevant IRB in a manner consistent with local regulations. 
Pertinent safety information will be submitted to the relevant IRBs during the course of 
the study in accordance with local regulations and requirements. It is the responsibility 
of the investigator to have prospective approval of the study protocol, protocol 
amendments, and ICFs, and other relevant documents, if applicable, from their local 

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IRB and provide documentation of approval to Veran Medical Technologies. All 
correspondence with the IRB should be retained in the Investigator File. 
Should the study be terminated early for any unanticipated reason, the investigator will 
be responsible for informing the IRB of the early termination. 
 
 
16. REFERENCES 
 
American Joint Committee on Cancer. Lung. In: AJCC Cancer Staging Manual, 8th ed. 
New York, NY: Springer: 431-456 (2017). 
 
Better pulmonary function and prognosis with video-assisted thoracic surgery than with 
thoracotomy. Kaseda S, Aoki T, Hangai N, Shimizu K Ann Thorac Surg. 2000 Nov; 
70(5):1644-6. 
 
Ceppa DP, Kosinski AS, Berry MF, et al. Thoracoscopic lobectomy has increasing 
benefit in patients with poor pulmonary function: a Society of Thoracic Surgeons 
Database analysis. Ann Surg. 2012;256(3):487–493. 
 
Declaration of Helsinki 59th World Medical Association General Assembly, Seoul, 
October 2008. Available at 
http://www.wma.net/en/30publications/10policies/b3/index.html Accessed January 
2011. 
 
Frank C. Detterbeck, Daniel J. Boffa, Anthony W. Kim, Lynn T. Tanoue The Eighth 
Edition Lung Cancer Stage Classification Chest, Volume 151, Issue 1, 2017, pp. 193- 
203. 
 
Directive 95/46EC of the European Parliament and the council on the protection of 
individuals with regard to the processing of personal data and on the free movement of 
such data. Available at http://ec.europa.eu/justice_home/fsj/privacy/docs/95-46- 
ce/dir1995-46_part1_en.pdf Accessed January 2009. 
 
EMA. Draft Guideline on good pharmacovigilance practices (GVP) – Module VIII. 
Post-authorisation safety studies. EMA/813938/2011. Available at 
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/02 
/WC500123204.pdf. Accessed February 2012. 
 
International Committee of Medical Journal of Editors (ICMJE). Uniform 
Requirements for Manuscripts Submitted to Biomedical Journals: Writing and Editing 
for Biomedical Publications. October 2008. Available from 
http://www.icmje.org/urm_full.pdf Accessed January 2011. 

Veran Medical Technologies, Inc. 
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International Safe Harbor Privacy Principles Safe Harbor Privacy Principles Issued by 
The US Department Of Commerce on July 21, 2000. Available at http:// 
export.gov/safeharbor/ Accessed January 2009. 
 
Mazzone et al, 2002; Riveria et al, 2003; Schriebner and McCrory, 2003. 
 
Rivera MP, Mehta AC, Wahidi MM. Establishing the diagnosis of lung cancer: Diagnosis and 
management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based 
clinical practice guidelines. Chest. 2013;143(5 Suppl):e142S-165S. 
 
Semaan R.W., Lerner A.D., Lee H.J., Feller-Kopman D., Yarmus L.B. Electromagnetic 
guidance for the diagnosis of pulmonary nodules: Don't put the nail in the coffin. 
(2016). American Journal of Respiratory and Critical Care Medicine, 194 (1), pp. 121. 
 
Silvestri GA, Vachani A, Whitney D, et al. A Bronchial Genomic Classifier for the Diagnostic 
Evaluation of Lung Cancer. The New England journal of medicine. 2015;373(3):243-251. 
 
Wahidi MM, Govert JA, Goudar RK, Gould MK, McCrory DC. Evidence for the treatment of 
patients with pulmonary nodules: when is it lung cancer?: ACCP evidence-based clinical 
practice guidelines (2nd edition). Chest. 2007;132(3 Suppl):94S-107S. 
 
Yarmus LB, Arias S, Feller-Kopman D, et al. Electromagnetic navigation transthoracic 
needle aspiration for the diagnosis of pulmonary nodules: a safety and feasibility pilot 
study. J Thorac Dis. 2016;8(1):186-19 

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APPENDIX A – INSTRUCTIONS FOR USE 

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APPENDIX B – VERAN CT SCAN 

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APPENDIX C – SAFETY AND COMPLAINT REPORTING FORMS