Clinical Description of a Bronchoscopic Approach to Ablate Lung Nodules Using the Emprint™ Ablation Catheter Kit With Thermosphere™ Technology
Conditions: Cancer, Lung, Cancer, Metastatic to Lung
Sponsor: Medtronic - MITG

 
 
 
 
 
Surgical Innovations 
Lung Health 
161 Cheshire Lane 
Suite 100 
Plymouth, MN 55441 
USA 
www.medtronic.com 
 
 
 
Document Cover Page 
 
Study: NAVABLATE 
 
Official Title: Clinical description of a bronchoscopic approach to ablate lung nodules using the Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology 
 
ClinicalTrials.gov ID: NCT03569111 
 
Document Type: Study Protocol 
 
Document Date: 26-SEP-2019 (Version 4.0) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Clinical Investigation Plan 
Clinical Investigation Plan/Study 
Title  
Clinical description of a bronchoscopic approach to ablate 
lung nodules using the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology 
Clinical Investigation Plan Identifier 
MDT18010ILSBA 
Study Product Name 
Emprint™ Ablation Catheter Kit with Thermosphere™ 
Technology 
Sponsor/Local Sponsor 
Medtronic  
Minimally Invasive Therapies Group 
Surgical Innovations, Lung Health 
161 Cheshire Lane, Suite 100 
Plymouth, MN 55441 
Covidien Services Europe 
(an indirect, wholly owned subsidiary of Medtronic plc) 
Block 3090-3094 Lake Drive 
Citywest Business Park 
Dublin, Ireland 
Document Version 
Version 4.0, 26-SEP-2019 
Lead Principal Investigators 
Kelvin K.W. Lau, MA, DPhil, FRCS(CTh) 
St Bartholomew's Hospital 
West Smithfield, London EC1A 7BE 
Calvin Ng, BSc MB BS MRCS FRCSEd MD FCSHK FHKAM FCCP 
Prince of Wales Hospital 
30-32 Ngan Shing St, Sha Tin 
Hong Kong 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of 
Medtronic. Any distribution, copying, or disclosure without the prior written authorization of 
Medtronic is strictly prohibited. Persons to whom the information is disclosed must know that it is 
confidential and that it may not be further disclosed by them. 
Covidien llc is an indirect wholly owned subsidiary of Medtronic plc. 
 
 
 
 

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1. Investigator Statement 
Study Product Name 
Emprint™ Ablation Catheter Kit with Thermosphere™ 
Technology 
Sponsor/Local Sponsor 
Medtronic  
Minimally Invasive Therapies Group 
Surgical Innovations, Lung Health 
161 Cheshire Lane, Suite 100 
Plymouth, MN 55441 
Covidien Services Europe 
(an indirect, wholly owned subsidiary of Medtronic plc) 
Block 3090-3094 Lake Drive 
Citywest Business Park 
Dublin, Ireland 
Clinical Investigation Plan Identifier 
MDT18010ILSBA 
Version Number/Date  
Version 4.0, 26-SEP-2019 
I have read the protocol, including all appendices, and I agree that it contains all necessary details for 
me and my staff to conduct this study as described. I will conduct this study as outlined herein and 
will make a reasonable effort to complete the study within the time designated. 
I agree to comply with ISO 14155:2011 (Clinical Investigation of Medical Devices for Human Subjects – 
Good Clinical Practice), the European Union Medical Device Regulation, and the International 
Conference on Harmonisation (ICH) of Technical Requirements For Registration of Pharmaceuticals 
For Human Use, ICH Harmonised Tripartite Guideline for Good Clinical Practice E6 (R1). I agree to 
ensure that the confidential information contained in this document will not be used for any purpose 
other than the evaluation and conduct of the clinical investigation without the prior written consent 
of Medtronic. 
I will provide all study personnel under my supervision copies of the protocol and access to all 
information provided by Medtronic. I will discuss this material with them to ensure that they are fully 
informed about the products and the study. 
Investigator’s Signature: 
 
Investigator’s Name: 
 
Institution: 
 
Date:  
 
 
 

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Table of Contents  
1. 
Investigator Statement ...................................................................................................... 2 
2. 
Glossary .............................................................................................................................. 6 
2.1. Terms ..................................................................................................................................... 6 
2.2. Definitions ............................................................................................................................... 7 
3. 
Synopsis ............................................................................................................................. 9 
4. 
Introduction ..................................................................................................................... 13 
4.1. Background ........................................................................................................................... 13 
4.2. Purpose ................................................................................................................................. 14 
5. 
Objectives and Endpoints ................................................................................................. 14 
5.1. Objectives ............................................................................................................................. 14 
5.1.1. 
Primary Objective .................................................................................................................. 14 
5.1.2. 
Secondary Objectives ............................................................................................................ 14 
6. 
Study Design .................................................................................................................... 15 
6.1. Duration ................................................................................................................................ 15 
6.2. Rationale ............................................................................................................................... 15 
7. 
Product Description.......................................................................................................... 17 
7.1. General ................................................................................................................................. 17 
7.2. Dosage Form and Route of Administration ............................................................................... 18 
7.3. Manufacturer ......................................................................................................................... 18 
7.4. Packaging .............................................................................................................................. 18 
7.5. Intended Use and Population .................................................................................................. 19 
7.6. Equipment ............................................................................................................................. 19 
7.7. Product Use ........................................................................................................................... 20 
7.8. Product Training Requirements ............................................................................................... 20 
7.9. Product Receipt, Tracking, Storage, Return, and Accountability ................................................. 20 
7.10. 
Intended Claims ............................................................................................................... 20 
8. 
Selection of Subjects ........................................................................................................ 21 
8.1. Study Population .................................................................................................................... 21 
8.2. Subject Enrollment ................................................................................................................. 21 
8.3. Inclusion Criteria .................................................................................................................... 21 
8.4. Exclusion Criteria ................................................................................................................... 22 

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9. 
Study Procedures ............................................................................................................. 22 
9.1. Schedule of Events ................................................................................................................. 22 
9.2. Subject Screening .................................................................................................................. 23 
9.3. Prior and Concomitant Medications ......................................................................................... 24 
9.4. Subject Consent ..................................................................................................................... 24 
9.5. Randomization and Treatment Assignment .............................................................................. 24 
9.6. Medication Compliance ........................................................................................................... 24 
9.7. Assessment of Efficacy ........................................................................................................... 25 
9.8. Assessment of Safety ............................................................................................................. 25 
9.8.1. 
Screening / Baseline Visit ...................................................................................................... 25 
9.8.2. 
Baseline Imaging ................................................................................................................... 25 
9.8.3. 
Nodule Characteristics .......................................................................................................... 26 
9.8.4. 
Index Procedure .................................................................................................................... 26 
9.8.5. 
Safety Endpoints ................................................................................................................... 27 
9.8.6. 
1-Month Follow-Up ............................................................................................................... 28 
9.8.7. 
Study Completion .................................................................................................................. 28 
9.9. Recording Data ...................................................................................................................... 28 
9.10. 
Deviation Handling ........................................................................................................... 28 
9.11. 
Subject Withdrawal or Discontinuation ............................................................................... 29 
10. Risks and Benefits ............................................................................................................ 30 
10.1. 
Potential Risks .................................................................................................................. 30 
10.1.1. 
Summary of Risk Management Report ............................................................................. 30 
10.1.2. 
Summary of Clinical Evaluation Report ............................................................................. 31 
10.1.3. 
Radiation Exposure ............................................................................................................ 31 
10.2. 
Potential Benefits ............................................................................................................. 32 
10.3. 
Risk-Benefit Rationale ....................................................................................................... 32 
11. Adverse Events and Device Deficiencies .......................................................................... 32 
11.1. 
Definitions/Classifications .................................................................................................. 32 
11.1.1. 
Adverse Event (AE) ............................................................................................................ 33 
11.1.2. 
Serious Adverse Event (SAE) .............................................................................................. 33 
11.1.3. 
Adverse Device Effect (ADE) .............................................................................................. 34 

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11.1.4. 
Serious Adverse Device Effect (SADE) ............................................................................... 34 
11.1.5. 
Unanticipated Serious Adverse Device Effect (USADE) ..................................................... 34 
11.1.6. 
Device Deficiency ............................................................................................................... 34 
11.1.7. 
Adverse Event Relationship Classification ......................................................................... 35 
11.1.8. 
Adverse Event Outcome Classification .............................................................................. 36 
11.2. 
Reporting of Adverse Events ............................................................................................. 37 
11.2.1. 
Notification to Authorities ................................................................................................. 37 
12. Data Review Committees ................................................................................................. 38 
13. Statistical Design and Methods ........................................................................................ 38 
14. Ethics ................................................................................................................................ 39 
14.1. 
Statement(s) of Compliance .............................................................................................. 39 
15. Study Administration ....................................................................................................... 40 
15.1. 
Monitoring ....................................................................................................................... 40 
15.2. 
Data Management ............................................................................................................ 41 
15.3. 
Direct Access to Source Data/Documents ........................................................................... 41 
15.4. 
Confidentiality .................................................................................................................. 41 
15.5. 
Liability ............................................................................................................................ 42 
15.6. 
CIP Amendments ............................................................................................................. 42 
15.7. 
Record Retention ............................................................................................................. 42 
15.8. 
Publication and Use of Information .................................................................................... 42 
15.9. 
Suspension or Early Termination ....................................................................................... 43 
15.10. 
Study Contact Information ................................................................................................ 44 
15.11. 
Financial Information ........................................................................................................ 44 
16. References ....................................................................................................................... 44 
17. Appendices ....................................................................................................................... 47 
17.1. 
User Manual ..................................................................................................................... 47 
17.2. 
Product Label ................................................................................................................... 47 
17.3. 
Bronchoscopic Ablation Patient Satisfaction and Pain Survey ............................................... 47 
17.4. 
Quality of Life Questionnaire ............................................................................................. 47 
17.5. 
NAVABLATE Adverse Event Reference List ......................................................................... 47 
17.6. 
Sample Informed Consent Form ........................................................................................ 47 
18. Version History ................................................................................................................. 47 
 

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2. Glossary 
2.1. Terms 
Acronym / Term 
Definition 
ADE 
adverse device effect 
ADL 
activities of daily living 
AE 
adverse event 
CBCT 
cone-beam computed tomography 
CIP 
clinical investigation plan 
CRF 
case report form 
CT 
computed tomography 
CTCAE 
Common Terminology Criteria for Adverse Events  
EC 
ethics committee 
ENB 
electromagnetic navigation bronchoscopy 
EU MDR 
European Union Medical Device Regulation 
EWC 
extended working channel 
GCP 
good clinical practice 
GOLD 
Global Initiative for Chronic Obstructive Lung Disease 
ICF 
informed consent form 
ICH 
International Conference on Harmonisation 
IFU 
Instructions for Use 
IRB 
institutional review board 
ISO 
International Organization for Standardization 
IV 
intravenous 
MHLW 
Ministry of Health, Labour, and Welfare 
PMV 
post-market vigilance 
RDC 
remote data capture 
SADE 
serious adverse device effect 
SAE 
serious adverse event 
SAP 
statistical analysis plan 
SBRT 
stereotactic body radiation therapy 
USADE 
unanticipated serious adverse device effect 
 

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2.2. Definitions 
Refer to the NAVABLATE Adverse Event Reference List (Appendix 17.5) for additional definitions. 
Adverse Event 
See Section 11.1.1. 
Adverse Device Effect 
See Section 11.1.3. 
Common Terminology Criteria for Adverse Events 
A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. 
The CTCAE system is a product of the US National Cancer Institute Cancer Therapy Evaluation Program.1 
This study will use Version 5.0 (published 27-NOV-2017), available at 
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50https://ctep.canc
er.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50  
Device Deficiency 
See Section 11.1.6. 
Instrumental Activities of Daily Living 
For the purpose of defining CTCAE grade, instrumental activities of daily living (ADL) refers to preparing 
meals, shopping for groceries or clothes, using the telephone, managing money, etc. 
Investigational Medical Device 
For the purpose of this clinical investigation plan, an Investigational Medical Device is defined as, “A 
device, including a transitional device, which is the object of an investigation.” The Investigational 
Medical Device being evaluated in this study is the Emprint™ Ablation Catheter Kit with Thermosphere™ 
Technology which has received the CE-Mark. 

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Serious Adverse Device Effect 
See Section 11.1.4. 
Serious Adverse Event 
See Section 11.1.2. 
Self-Care Activities of Daily Living 
For the purpose of defining CTCAE grade, self-care activities of daily living (ADL) refer to bathing, 
dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.1 
Technical Success 
An evaluation of whether the lung nodule was treated according to the study protocol as determined at 
the immediate post-procedural timepoint. This is in contrast to procedures in which the protocol could 
not be executed completely, either for technical reasons or for reasons related to comorbid disease.2   
Technique Efficacy 
An evaluation of whether the lung nodule was effectively ablated. Evaluates whether complete ablation 
of the nodule was achieved as evidenced by imaging follow-up 1-month post-procedure (including a 
window of 20-40 days post-procedure).2  
Unanticipated Serious Adverse Device Effect 
See Section 11.1.5. 
 
 

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3. Synopsis 
Title 
Clinical description of a bronchoscopic approach to ablate lung 
nodules using the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology 
Clinical Study Type 
Prospective, single-arm, multicenter, non-randomized 
Study Phase 
Post-market 
Product Name 
Emprint™ Ablation Catheter Kit with Thermosphere™ Technology 
Sponsor/Local Sponsor 
Medtronic  
Minimally Invasive Therapies Group 
Surgical Innovations, Lung Health 
161 Cheshire Lane, Suite 100 
Plymouth, MN 55441 
Covidien Services Europe 
(an indirect, wholly owned subsidiary of Medtronic plc) 
Block 3090-3094 Lake Drive 
Citywest Business Park 
Dublin, Ireland 
Indications for 
Use/Intended Use Under 
Investigation  
Indications for Use:  The Emprint™ Ablation System with 
Thermosphere™ Technology is intended for use in percutaneous, 
laparoscopic, endoscopic, and intraoperative coagulation (ablation) of 
soft tissue, including partial or complete ablation of non-resectable 
liver tumors. 
The Emprint™ Ablation System with Thermosphere™ Technology is 
not intended for use in cardiac procedures. 
Intended Use:  The Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology is designed for use with the Emprint™ 
Ablation System and is compatible with superDimension™ Navigation 
System’s Extended Working Channel (EWC) and Edge™ Bronchoscope 
Adapter.  
In this study, the flexible Emprint™ Ablation Catheter will be deployed 
bronchoscopically using the superDimension™ Navigation System’s 
EWC in order to ablate lung nodules.  

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Devices will be used within approved intended use as described in the 
approved Instructions for Use (IFU) for which CE mark has been 
obtained per country.  
Investigation Purpose 
The purpose of this investigation is to characterize the safety and 
performance of the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology in clinical use. 
Product Status 
The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology 
is CE marked and approved for use in each country. 
Primary Objective 
The primary objective of this prospective, single-arm, multicenter, 
non-randomized study is to characterize the safety of the Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology device in 
subjects undergoing lung ablation procedures. 
The primary endpoint is the composite rate of adverse events related 
to the Emprint™ Ablation Catheter Kit with Thermosphere™ 
Technology through 1-month follow-up. 
Secondary Objectives 
The following secondary endpoints will be evaluated: 
• 
Composite rate of serious adverse events related to the Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology through 1-
month follow-up. 
• 
Composite rate of all adverse events related to the procedure or 
study devices through 1-month follow-up. 
• 
Composite rate of all serious adverse events related to the 
procedure or study devices through 1-month follow-up. 
• 
Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain 
and Satisfaction Survey) 
• 
Quality of life (EQ-5D Scale) 
• 
Technical success 
• 
Technique efficacy 
Safety Assessments 
For safety reporting, only adverse events related to the Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology, accessory 
devices, or study procedures will be captured and reported until the 
subject exits the study. Adverse events will be summarized as event 
counts and percentages that occurred during the ablation procedure 
or were detected after the procedure. For the primary endpoint, 
relationship specifically to the Emprint™ Ablation Catheter with 
Thermosphere™ Technology device will be assessed. 

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All adverse events related to the Emprint™ Ablation Catheter with 
Thermosphere™ Technology will be graded for severity based on the 
Common Terminology Criteria for Adverse Events.1 
Study Design 
This is a prospective, single-arm, multicenter, non-randomized study. 
Up to 3 sites in up to 3 countries will enroll up to 30 subjects in total. 
The study is designed to characterize the safety and performance of 
the bronchoscopic ablation procedure using the Emprint™ Ablation 
Catheter Kit with Thermosphere™ Technology.  
Randomization 
This study is not randomized. 
Sample Size 
Up to 30 subjects will be enrolled at up to 3 sites in up to 3 countries. 
Inclusion/Exclusion Criteria 
Inclusion Criteria: 
1. Subject is ≥ 18 years of age 
2. Subject has provided informed consent  
3. Subject is able and willing to comply with the study follow-up 
schedule 
4. Subject has a definitive diagnosis of cancer in the lung  
5. Target nodule is ≤ 30mm in maximum diameter  
6. There is ≥ 5mm of nodule-free lung parenchyma between 
target nodule and pleura or fissure 
7. Subject is a candidate for an elective electromagnetic 
navigation bronchoscopy (ENB) procedure 
8. Subject is a candidate for an elective lung ablation procedure 
according to standard of care and product Instructions for 
Use 
9. Subject is not a candidate for lung surgery or refuses lung 
surgery 
10. Subject is not a candidate for stereotactic body radiation 
therapy (SBRT) or refuses SBRT 
Exclusion Criteria: 
1. Target nodule is abutting main stem bronchus, main 
pulmonary vasculature, esophagus and/or trachea 
2. Patients currently diagnosed with Global Initiative for Chronic 
Obstructive Lung Disease (GOLD) Stage IV emphysema 
3. Female subjects who are pregnant or nursing as determined 

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by standard site practices 
4. Subject has participated in an investigational drug or device 
research study within 30 days of enrollment that would 
interfere with this study 
5. The investigator determines that participation in the study 
may jeopardize the safety or welfare of the subject 
Study Procedures and 
Assessments 
Subjects will be evaluated at: 
• 
Baseline: To determine study eligibility and collect baseline 
information (demographics, medications, medical history, etc.), 
Quality of Life Evaluation (EQ-5D scale) 
• 
Procedure:  To re-confirm nodule eligibility criteria, and collect 
nodule characteristics, medication changes, procedure plan and 
procedure information, standard imaging, immediate post-
procedure evaluation, adverse event evaluation 
• 
1-month follow-up (20-40 days post-procedure):  Standard imaging, 
follow-up evaluation, medication changes, adverse event 
evaluation, Bronchoscopic Ablation Patient Satisfaction and Pain 
Survey, Quality of Life Evaluation (EQ-5D scale) 
 Statistics 
No formal sample size estimates were conducted. Based on the 
design and purpose of the study, there is no required number of 
subjects to prove study claims or objectives. The study is predefined 
to include up to 30 subjects with 20 being the approximate minimum. 
Study data will be summarized as descriptive statistics (frequencies 
and percentages) and will inform future studies.  
 
 
 

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4. Introduction  
4.1. Background  
While surgical resection remains the gold standard for the treatment of localized well-defined lung 
tumors, many patients are medically inoperable due to existing comorbidities. For this reason, 
alternative modalities are needed as an option for inoperable subjects.  
Image-guided thermal ablation is a minimally invasive option that is becoming increasingly accepted for 
solitary lung tumors or selected metastatic tumors in patients who are medically inoperable.3 
Approaches include radiofrequency ablation, microwave ablation, cryoablation, and laser ablation.4, 5 
Radiofrequency ablation has been the most well-characterized thermal ablation method to date. 
Radiofrequency ablation uses electromagnetic energy to induce local tissue heating and cell death by 
coagulation necrosis.6, 7 Radiofrequency ablation has been recommended for peripheral tumors < 3 cm 
in inoperable patients.8 While effective, use of radiofrequency ablation is limited by high rates of 
incomplete ablation and local recurrence, particularly in large tumors.9, 10 
Microwave ablation involves placement and activation of an antenna directly into the target tissue. The 
system generates an alternating electric field which radiates microwave energy into target tissue. This 
causes rotation of water molecules, leading to friction, and resulting in thermal necrosis of the tissue. 
Advantages of microwave ablation over radiofrequency ablation include faster treatment of a larger 
tissue volume, and the minimization of the heat sink effect, in which local recurrence is increased in 
perivascular regions when heat is drawn away from the ablation zone by flowing blood faster than can 
be generated by the ablation device. Faster, hotter, and larger ablation zones also reduce the number of 
antenna placements required.4, 5, 11 
However, previously available microwave ablation systems were still challenged by variations in the 
anatomical environment (e.g., proximity to large vessels, size of tumor, tissue type, tissue hydration), 
particularly in the lung. These factors influence the predictability of ablation zone size and shape, 
preventing complete ablation of diseased tissue and ultimately resulting in local recurrence.  
The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is a novel thermal ablation device 
that uses wavelength-controlled, field-based energy to deliver adequate energy to create a large, 
spherical active zone regardless of tissue environment.12-14 This resilience to anatomical distortion 
minimizes reliance on passive heating and reduces the number of overlapping ablations required to 
achieve a desired ablative effect.  
The safety and performance data currently available for use of the Emprint™ Ablation System in the lung 
include a published study15 and an unpublished sponsored study (Clinicaltrials.gov identifier 
NCT02323854) describing use of the Emprint™ Ablation System using a percutaneous approach. These 
studies demonstrate that the Emprint™ Ablation System performed as expected in the lung with a safety 

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profile consistent with the known safety profile for ablation in the lung. Additionally, an external 
research project has been initiated which will report on a retrospective analysis of use of the Emprint™ 
Ablation System in lung malignancies using a percutaneous approach. 
The safety of image-guided bronchoscopic access of lung nodules using the superDimension™ navigation 
system has been established. In a meta-analysis of 15 published studies, pneumothorax occurred in 
3.1% of patients (1.6% with intervention) and minor/moderate bleeding in 0.9%.16 This is lower than the 
pooled complication rates of computed tomography (CT)-guided transthoracic core biopsy and fine-
needle aspiration across 32 publications: 18.8%-25.3% pneumothorax, 4.3%-5.6% pneumothorax with 
intervention, 6.4%-18.0% pulmonary hemorrhage, and 1.7%-4.1% hemoptysis.17 
The Emprint™ Ablation Catheter with Thermosphere™ Technology was introduced as part of the 
Emprint™ Ablation System to provide a bronchoscopic approach using the superDimension™ navigation 
system. The current clinical study will be conducted to characterize the safety and performance of the 
Emprint™ Ablation Catheter with Thermosphere™ Technology for bronchoscopic thermal ablation in the 
lung. 
4.2. Purpose 
The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation 
Catheter Kit with Thermosphere™ Technology in clinical use.  
5. Objectives and Endpoints 
5.1. Objectives 
5.1.1. 
Primary Objective 
The primary objective of this prospective, single-arm, multicenter, non-randomized study is to 
characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in 
subjects undergoing lung ablation procedures. 
The primary endpoint is the composite rate of adverse events (AEs) related to the Emprint™ Ablation 
Catheter Kit with Thermosphere™ Technology through 1-month follow-up. 
5.1.2. 
Secondary Objectives  
The following secondary endpoints will be evaluated: 
• 
Composite rate of serious AEs (SAEs) related to the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology through 1-month follow-up. 
• 
Composite rate of all AEs related to the procedure or study devices through 1-month follow-up. 

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• 
Composite rate of all SAEs related to the procedure or study devices through 1-month follow-up. 
• 
Patient satisfaction and pain (Bronchoscopic Ablation Patient Pain and Satisfaction Survey) 
• 
Quality of life evaluation (EQ-5D scale) 
• 
Technical success:  An evaluation of whether the lung nodule was treated according to the study 
protocol as determined at the immediate post-procedural timepoint. This is in contrast to 
procedures in which the protocol could not be executed completely, either for technical reasons or 
for reasons related to comorbid disease.2 
• 
Technique efficacy:  An evaluation of whether the lung nodule was effectively ablated. Evaluates 
whether complete ablation of the nodule was achieved as evidenced by imaging follow-up 1-month 
post-procedure (including a window of 20-40 days post-procedure).2 
6. Study Design  
This is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 
countries/regions will enroll up to 30 subjects in total. The study is designed to characterize the safety 
and performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit 
with Thermosphere™ Technology.  
6.1. Duration 
Assessments will occur at baseline, during and immediately post-procedure, and at 1-month follow-up. 
The expected duration of each subject’s participation in the study from the baseline visit to the 1-month 
follow-up is up to approximately 2 months (based on a baseline visit a maximum of 30 days pre-
procedure and a follow-up window up to 40 days post-procedure). 
Based on the expected enrollment rate of 1 subject per site per month, the total duration of the study 
from first subject enrollment to last subject follow-up is expected to be approximately 18 months. 
6.2. Rationale  
This study is a prospective, single-arm, multicenter, non-randomized study. Up to 3 sites in up to 3 
countries will enroll up to 30 subjects in total. The study is designed to characterize the safety and 
performance of the bronchoscopic ablation procedure using the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology.  
This study is single-arm and is not statistically powered. A maximum number of sites and subjects is 
proposed in order to provide a multicenter evaluation while minimizing risk to subjects. Enrollment of 
subjects who are not candidates for lung surgical resection or SBRT (or who refuse surgical resection or 
SBRT) will minimize exposure to only those with limited clinically viable options. Restricting nodules to 
those with ≥5mm of nodule-free lung parenchyma between the target nodule and pleura or fissure and 
excluding target nodules abutting the main stem bronchus, main pulmonary vasculature, esophagus 

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and/or trachea will minimize exposure and risk to the vasculature and surrounding tissue. While these 
inclusion/exclusion criteria are designed to minimize risk to subjects, results may not be generalizable to 
other populations of patients not evaluated as part of this study protocol. In addition, the results of this 
study will represent the outcomes in a small number of centers with experienced users and may not be 
generalizable across all institutions. If the study results support further clinical research, additional 
studies will examine a broader patient population across more diverse clinical sites. 
Prior bench, preclinical, and clinical testing to justify the current clinical evaluation of the Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology have been described in the Clinical Evaluation 
Report for the Covidien Emprint™ Ablation System and Accessories and are summarized briefly below. 
Design verification and validation test results provide reasonable assurance that the device conforms to 
the requirements for its indications for use and intended use.  
Extensive bench verification was performed to confirm the catheter’s compatibility with the system 
generator, demonstrate its robustness to mechanical stresses, and establish its reliability, after 
conditions of misuse. Tissue-based testing was conducted using an ex-vivo soft tissue model (bovine 
liver) to confirm functionality. The catheter passed all verification tests, meeting all of the associated 
design requirements. The verification tests were designed to be clinically relevant and their successful 
completion supports the readiness of the device for clinical use. All reported deviations were minor in 
nature and did not impact the overall test result. 
Biocompatibility evaluations and appropriate testing were performed on the patient contact 
components of the Emprint™ Ablation System. Arnitel EM740 (Trans Grey 431 C) is the only patient-
contacting material in the ablation catheter (all other materials are considered non-patient contacting). 
The catheter passed all ISO and MHLW cytotoxicity, sensitization, and hemolysis tests as well as ISO 
systemic injection testing, ISO intracutaneous testing, and physiochemical testing. 
A Covidien-sponsored chronic in vivo study examined use of the Emprint™ Ablation Catheter in 6 
domestic male swine undergoing lung bronchoscopic ablation in a survival study. All ablations were 
performed using the Emprint™ Ablation Catheter with the Emprint™ Ablation System. Safety endpoints 
included incidence/severity assessment of pneumothorax, intra-operative bleeding assessment after 
device use, macroscopic/microscopic evaluation of representative tissues, and overall animal health. 
Observations did not raise a safety concern regarding use of the ablation catheter or microwave ablation 
procedure in the lung and were consistent with known clinical findings in humans. Most findings were 
considered common observations in laboratory animals following an anesthetic and surgical procedure 
and no abnormalities were attributed to the catheter device.  
Eight published clinical studies evaluated the safety and performance of the Emprint™ ablation system 
for primary or metastatic cancer. Six studies were conducted in the liver,18-23 1 in the pancreas,24 and 1 in 
the lung.15 Ierardi 2017 evaluated 19 patients with 31 primary or metastatic lung tumors (28 microwave 
ablation procedures) undergoing percutaneous lung ablation with the Emprint™ ablation system.15 Only 

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1 major complication occurred: pneumothorax. Minor complications included self-resolving 
pneumothorax (14 of 28 sessions) and perilesional hemorrhagic effusion (13 of 28 sessions), as well as 
hospitalization-related lower urinary tract infection in 3 of 28 sessions.15 An additional unpublished 
sponsored study (NCT02323854) also describes use of the Emprint™ Ablation System in the lung using a 
percutaneous approach in 15 subjects. All 15 subjects underwent ablation followed by planned surgical 
resection. Complete ablation was detected in 54.4% (6/11), incomplete ablation in 36.4% (4/11), and 
delayed necrosis in 9.1% (1/11). There were no device-related AEs reported. A total of 5 SAEs occurred 
in 3 subjects (20%). SAEs included acute respiratory failure, pulmonary air leakage, prolonged air leak, 
Guillain-Barre Syndrome, and respiratory arrest, which resolved after the procedure. All 5 SAEs were 
either not related or unlikely to be related to the procedure. Twelve AEs were related to the ablation 
procedure, including bleeding, pneumothorax (Grade 1, n=4), hemoptysis (Grade 1, n=1), hemothorax 
(Grade 2, n=2), and vasovagal syncope (Grade 1, n=1). These studies demonstrate that the Emprint™ 
Ablation System performed as expected with a safety profile consistent with the known safety profile for 
lung ablation.  
The Emprint™ Ablation Catheter was introduced as part of the Emprint™ Ablation System in 2016. Its CE 
mark was based on equivalence to the percutaneous antenna utilizing the same Thermosphere™ 
technology. Therefore, the proposed clinical study will be conducted specifically to characterize the 
safety and performance of the catheter device in the lung with a bronchoscopic approach. 
7. Product Description 
7.1. General 
The device under study is the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology 
(CA108L1), an endoscopic ablation accessory for use with the Emprint™ Ablation System.  The Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology is for use with the Emprint™ Ablation System 
with Thermosphere™ Technology for the ablation of lung tissue. 
Microwave-based soft tissue ablation uses microwave energy to increase target tissue temperature 
resulting in thermocoagulation and cellular death. Microwave energy is supplied by a generator and 
emits from the exposed portion of an antenna. The Evident™ Microwave Ablation System was designed 
to provide microwave power for ablation of soft tissue during medical procedures. It received the CE 
mark in 2007 and 510k clearance in 2008. The Emprint™ Ablation System is an evolution of the 
technology within the Evident™ Microwave Ablation System, which received both CE mark and 510k 
clearance in 2014. The Emprint™ system utilizes higher power, a more efficient cable and antenna 
design, and an antenna designed to create a more spherical field pattern (Thermosphere™ technology). 
An ablation catheter has been added as an accessory to the Emprint™ system- to be used in a 
bronchoscopic approach for lung ablation.  

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The shelf life of the product is intended to be expanded to 24 months which may occur during the 
course of the study. No other changes to the product are anticipated. 
7.2. Dosage Form and Route of Administration 
The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is deployed endoscopically 
(bronchoscopically) and will be used to conduct bronchoscopic ablations in the lung using the 
superDimension™ navigation system.  
7.3. Manufacturer 
The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is manufactured by Covidien llc, 
an indirect wholly owned subsidiary of Medtronic plc. 
7.4. Packaging 
The Emprint™ Ablation Catheter will be provided to health care providers as part of a kit (Catalog No. 
CA108L1). In addition to the catheter, the kit includes a stabilizing rail that is attached to the Edge 
Bronchoscope Adapter and a locking clip. Products used in this study that are commercially available are 
packaged and labelled accordingly. Labeling of devices will be provided in accordance with local 
language requirements. 
 

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Figure 1. The Emprint™ Ablation Catheter, rail, and clip. (1) Intravenous IV Bag Spike; (2) Drip Chamber; 
(3) Pump Tubing; (4) Generator Connector; (5) Ablation Catheter Handle; (6) Top Groove, (7) Control Ring, 
(8) Radiating Section; (9) Clip; (10) Rail 
7.5. Intended Use and Population 
The Emprint™ Ablation System with Thermosphere™ Technology is intended for use in percutaneous, 
laparoscopic, endoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or 
complete ablation of non-resectable liver tumors. 
The Emprint™ Ablation System with Thermosphere™ Technology is not intended for use in cardiac 
procedures. 
This study will evaluate the population of patients where the use of the Emprint™ Ablation Catheter Kit 
with Thermosphere™ Technology is conducted via a bronchoscope for ablation of malignant nodules in 
the lung. 
7.6. Equipment 
The Emprint™ Ablation Catheter is designed for use with the Emprint™ system components (Figure 1 
above) and is compatible with the Covidien Edge™ or Edge™ Firm Tip Extended Working Channel (EWC) 

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and Edge Bronchoscope Adapter. The system’s reusable cable (connects the percutaneous antenna to 
the microwave generator) is not used with the flexible catheter, as the catheter is designed to connect 
to the generator directly. 
Sites must have access to the superDimension™ navigation system utilizing either software version 6 or 
higher at the time of study initiation for each site, with potential for upgrade to the most recent 
software release throughout the duration of the study. Sites must also have a procedure room equipped 
with a cone-beam computed tomography (CBCT) imaging system. Sites may also use the CrossCountry™ 
Transbronchial Access Tool to obtain access. 
7.7. Product Use 
For the purpose of this post-market clinical study, the Emprint™ ablation catheter and Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology should be used according to manufacturer’s 
Instructions for Use and standard-of-care. Typically, one ablation catheter is used per procedure but 
more than one may be used at the investigator’s discretion. 
7.8. Product Training Requirements 
Physicians must have documented completion of the manufacturer’s bronchoscopic ablation training 
program and sufficient experience conducting ENB procedures and in using CBCT, the CrossCountry™ 
Access Tool, and the Emprint™ ablation system. Documented completion will be recorded on the Study 
Enrollment Eligibility Form. 
7.9. Product Receipt, Tracking, Storage, Return, and 
Accountability 
The study devices provided by the Sponsor will be recorded on the study specific Product Accountability 
Log. Information to be recorded will include, but is not limited to, date of receipt, and the date used or 
date of return to the Sponsor. The study-specific devices shall be kept in a locked room. 
The study devices provided by the Sponsor will be labeled with a study-specific label indicating that it is 
only to be used for study subjects.  
7.10. Intended Claims 
The purpose of this investigation is to characterize the safety and performance of the Emprint™ Ablation 
Catheter Kit with Thermosphere™ Technology in clinical use. This study does not specifically evaluate 
efficacy claims. 

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8. Selection of Subjects 
8.1. Study Population 
The study population will consist of consented adults undergoing bronchoscopic lung ablation 
procedures using electromagnetic navigation bronchoscopy (ENB). Additional inclusion and exclusion 
criteria are listed below. 
8.2. Subject Enrollment 
Up to 30 subjects will be enrolled at up to 3 sites in up to 3 regions. The minimum and maximum 
number of subjects to be included at each site are not prespecified since the study is not statistically 
powered. 
For the purpose of this clinical study investigational plan, the point of enrollment is defined as the 
insertion of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology into the EWC.  
Subjects will be approached to obtain written informed consent prior to any institution non-standard-of-
care assessments or study-specific data being collected. During the index procedure imaging, nodule 
eligibility criteria will be re-confirmed. Any patients with nodules no longer meeting eligibility criteria 
will not be enrolled. Subjects who provide study consent but then are determined to be ineligible prior 
to the insertion of the ablation catheter will be considered screen failures and documented as such in 
the database. 
8.3. Inclusion Criteria 
1. Subject is ≥ 18 years of age 
2. Subject has provided informed consent  
3. Subject is able and willing to comply with the study follow-up schedule 
4. Subject has a definitive diagnosis of cancer in the lung 
5. Target nodule is ≤ 30mm in maximum diameter  
6. There is ≥ 5mm of nodule-free lung parenchyma between target nodule and pleura or fissure 
7. Subject is a candidate for an elective ENB procedure 
8. Subject is a candidate for an elective lung ablation procedure according to standard of care and 
product Instructions for Use 
9. Subject is not a candidate for lung surgery or refuses lung surgery 
10. Subject is not a candidate for stereotactic body radiation therapy (SBRT) or refuses SBRT 

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8.4. Exclusion Criteria 
1. Target nodule is abutting main stem bronchus, main pulmonary vasculature, esophagus and/or 
trachea 
2. Patients currently diagnosed with Global Initiative for Chronic Obstructive Lung Disease (GOLD) 
Stage IV emphysema 
3. Female subjects who are pregnant or nursing as determined by standard site practices 
4. Subject has participated in an investigational drug or device research study within 30 days of 
enrollment that would interfere with this study 
5. The investigator determines that participation in the study may jeopardize the safety or welfare 
of the subject 
9. Study Procedures  
Following confirmation of eligibility and informed consent, subjects with inoperable lung nodules will 
undergo an ablation procedure using a bronchoscopic approach. A target nodule will be identified on a 
pre-procedure CBCT scan. Nodule localization will be aided by ENB using the superDimension™ 
navigation system. Once localized, if no suitable bronchus sign leads to the proposed area to ablate, 
access to the region may be obtained using the CrossCountry™ Transbronchial Access Tool. Once 
ablation region access has been achieved, the ablation catheter will be placed inside the EWC and will 
be unsheathed inside the target nodule. Correct positioning will be verified using CBCT and the nodule 
will then be ablated. AEs related to Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, 
accessory devices, or study procedures will be captured and reported until the 1-month follow-up visit.  
9.1. Schedule of Events 
Variables to be collected (following confirmation of eligibility and written informed consent), follow-up 
visit schedule, and tests to be performed at each visit are described in Table 1 below. 

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Table 1. Schedule of Events.  
 
 
Baseline 
(Day -30 to Day 0) 
During the 
Procedure and 
Immediately Post-
Procedure 
1-Month Follow-up 
(20 to 40 Days Post-
Procedure) 
Subject demographics 
X 
 
 
Medical history (Lung 
Diagnoses, Previous Lung 
procedures, Lung function 
tests, etc.)  
X 
 
 
Eligibility assessment 
X 
X 
 
Nodule characteristics 
 
X 
 
Procedural information 
 
X 
 
Adverse event assessment 
 
X 
X 
Imaging 
X* 
X 
X 
Concomitant medications 
X 
X 
X 
Quality of life survey (EQ-5D) 
X 
 
X 
Bronchoscopic Ablation 
Patient Pain and Satisfaction 
Survey 
 
 
X 
*Standard-of-care CT scan performed prior to consent.  
9.2. Subject Screening  
A baseline visit will be performed within 30 days prior to the scheduled procedure to assess study 
eligibility. During the index procedure imaging, nodule eligibility criteria will be re-confirmed. Consented 
subjects will be considered for the study if they meet specified inclusion criteria and none of the 
exclusion criteria. The criteria for enrollment must be followed explicitly.  
Subjects who provide study consent, but then are determined to be ineligible prior to the start of the 
ablation portion of the procedure will be considered screen failures and will not require additional study 
follow-up visits. The reason for the Screen Failure will be clearly documented on the applicable 
electronic case report forms (eCRFs). Screen failures will not be counted towards the number of study 
subjects. 

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9.3. Prior and Concomitant Medications 
All prior and concomitant medications should be managed according to standard-of-care.  
9.4. Subject Consent 
Subjects will be approached to obtain written informed consent prior to any institution non-standard-of-
care assessments or study-specific data being collected. The purpose of the study and the benefits and 
risks of participating in the study will be explained to the subject and the consent process must be 
documented accordingly.  
Subjects will be informed that their participation in this study is voluntary and that they may refuse to 
participate or discontinue from the study at any time. Additionally, subjects will be informed that 
despite signing informed consent, the screening assessments may demonstrate the subject is not a 
suitable candidate for the study or the ablation procedure and may be withdrawn. Subjects will be given 
the opportunity to ask the investigator questions so that they are adequately informed about the 
research.  
After being informed of the nature of the study, subjects who agree to study participation must sign a 
written informed consent form (ICF) that has been approved by the appropriate Ethics Committee (EC) 
or Institutional Review Board (IRB)  and Regulatory Authority if required per country, of the respective 
clinical site. A copy of the signed ICF must be provided to the subject. 
For this study, the subject must sign and date the ICF personally. The use of Legally Authorized 
Representatives, Healthcare Proxies or any other means of representation will not be permitted. All 
procedures evaluated in this study are considered elective; no emergency procedures or circumstances 
where the subject is unable to give consent will be permitted according to the study inclusion criteria. 
If new information becomes available that may affect a subject’s decision to continue to take part in the 
study, this information will be discussed with the subject. 
The principal investigator or his/her authorized designee must conduct the informed consent process. 
9.5. Randomization and Treatment Assignment 
Not applicable. There are no treatment arms or randomizations required for this study. 
9.6. Medication Compliance 
Not applicable. There are no required medications or medication protocols for this study. 

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9.7. Assessment of Efficacy 
The following efficacy endpoints will be evaluated: 
• 
Technical Success:  An evaluation of whether the lung nodule was treated according to the study 
protocol as determined at the immediate post-procedural timepoint. This is in contrast to 
procedures in which the protocol could not be executed completely, either for technical reasons or 
for reasons related to comorbid disease.2 
• 
Technique Efficacy:  An evaluation of whether the lung nodule was effectively ablated. Evaluates 
whether complete ablation of the nodule was achieved as evidenced by imaging follow-up 1-month 
post-procedure (including a window of 20-40 days post-procedure).2 
Full procedures for study visits and the index ablation procedure are described in the section 
“Assessment of Safety” below.  
9.8. Assessment of Safety 
9.8.1. 
Screening / Baseline Visit 
A screening/baseline visit will be performed within 30 days prior to the ablation procedure to assess 
eligibility. The following assessments will be performed and the results recorded on the appropriate 
subject eCRFs: 
• 
Verification of eligibility criteria 
• 
Subject demographics (e.g.,. subject age, sex, ethnicity, race) 
• 
Subject medical history (e.g., COPD, asthma, emphysema, tobacco history, cancer diagnosis) 
• 
History of prior invasive lung procedures 
• 
Medication use (e.g., immunotherapy, chemotherapy, targeted antineoplastic therapy, prescription 
antithrombotics)   
• 
Pulmonary function testing (if available per standard of care) 
• 
Quality of Life Survey (EQ-5D) 
9.8.2. 
Baseline Imaging 
In accordance with inclusion criteria, nodules ≤ 30mm in maximum diameter with ≥ 5mm of nodule-free 
lung parenchyma between target nodule and pleura or fissure are eligible to be considered target 
nodules for the study analysis. This will be based on standard-of-care (SOC) baseline imaging. 
One target nodule per subject will be identified on a SOC baseline CT prior to patient consent. If the 
study subject has more than one nodule meeting the above criteria, the most easily accessible nodule, 
as determined by the physician investigator, will be targeted for the study. 

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9.8.3. 
Nodule Characteristics 
Nodule characteristics (e.g., size, location, morphology) will be captured at procedure. 
9.8.4. 
Index Procedure 
The index procedure workflow is shown in Figure 2. The EWC will be inserted and navigation to the 
target will be conducted according to the manufacturer’s Instructions for Use. 
CBCT will be used to confirm target nodule localization using fluoroscopy overlay. If CT indicates the 
absence of a bronchus sign leading to the center of the target nodule, access to the nodule may be 
obtained using the CrossCountry™ Transbronchial Access Tool under CBCT guidance. 
During the index procedure imaging, nodule eligibility criteria will be re-confirmed. Any patients with 
nodules no longer meeting eligibility criteria will not be enrolled. For the purpose of this clinical study 
investigational plan, the point of enrollment is defined as the insertion of the Emprint™ Ablation 
Catheter Kit with Thermosphere™ Technology into the EWC. 
A high-level procedure workflow is shown below. Investigators will refer to the manufacturer’s 
instructional documents for additional detail. 

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Figure 2. Index procedure workflow 
 
9.8.5. 
Safety Endpoints 
The primary objective of this prospective, single-arm, multicenter, non-randomized study is to 
characterize the safety of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology device in 
subjects undergoing lung ablation procedures. 
The primary endpoint is the composite rate of AEs related to the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology through 1-month follow-up. 
In addition, the following secondary safety endpoints will be evaluated: 
• 
Composite rate of SAEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ 
Technology through 1-month follow-up. 
• 
Composite rate of all AEs related to the procedure or study devices through 1-month follow-up. 
• 
Composite rate of all SAEs related to the procedure or study devices through 1-month follow-up. 
All AEs related to the Emprint™ Ablation Catheter with Thermosphere™ Technology will be graded for 
severity based on the Common Terminology Criteria for Adverse Events.1 

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For safety reporting, only AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ 
Technology, accessory devices, or study procedures will be captured and reported until the subject exits 
the study (refer to Section 11.1 for additional details). Related AEs will be summarized as the event 
counts and percentage which occurred during the ablation procedure or detected after the procedure 
within the 1-month reporting timeframe. For the primary endpoint, relationship specifically to the 
Emprint™ Ablation Catheter with Thermosphere™ Technology device will be assessed. 
9.8.6. 
1-Month Follow-Up 
The study subject will complete the study at the conclusion of the 1-month follow-up visit, conducted 
per standard local practice, but within the window of 20-40 days after the study index procedure. 
The following assessments will be performed and the results recorded on the appropriate subject eCRFs: 
• 
Medication use (e.g., immunotherapy, chemotherapy, targeted antineoplastic therapy, prescription 
antithrombotics)   
• 
A follow-up CT scan at this timepoint will be used for the evaluation of Technique Efficacy 
• 
AE assessment (AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, 
accessory devices, or study procedures) 
• 
Quality of life survey (EQ-5D) 
• 
Bronchoscopic Ablation Patient Pain and Satisfaction Survey 
9.8.7. 
Study Completion 
Subjects will complete the study at the completion of the 1-month post-procedure visit. No additional 
study-specific care will be provided to study subjects after completion of the study. Standard of care 
should continue. The reporting window for the 1-month follow-up is 20-40 days. 
9.9. Recording Data 
This study will utilize an eCRF. The eCRF will be used to capture the required data elements. Medical and 
study records, rather than eCRFs, will serve as the source documentation. 
9.10. Deviation Handling 
No written waivers from the CIP will be granted. The Principal Investigator must make every effort to 
follow the CIP, unless the deviation is necessary in an emergent situation to protect the rights, safety 
and/or well-being of the subject. Deviations from the CIP will be collected on a Protocol Deviation CRF 
and reviewed with the Principal Investigator to ensure compliance.  
The investigator must notify Medtronic and the reviewing ethics committee (EC) / institutional review 
board (IRB) of any deviation from the Investigational Plan when specific to the protection of the life or 

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physical well-being of a subject in an emergency. Such notice must be given as soon as possible, but in 
no event later than five (5) working days after the emergency has occurred.  All study deviations will be 
reported by Medtronic to the Regulatory Authority (if applicable) via either Final Clinical Study Report or 
separate notification in case of substantial CIP deviation, for which the Regulatory Authority approval is 
required before its implementation. 
If a pattern of non-compliance is noted, the study manager will determine the course of action to take, 
such as root cause, review relevant CIP procedures and as applicable retrain and verify understanding of 
the issue in question. This will be documented in the Study Master Files. In the case of repeated or 
serious non-compliance, the Sponsor reserves the right to disqualify the offending site. 
9.11. Subject Withdrawal or Discontinuation  
Subjects may voluntarily withdraw from the study if they no longer wish to have their study-related 
information used. Additionally, the Principal Investigators may withdraw or choose not to enroll subjects 
if they feel they do not meet the CIP defined inclusion and exclusion criteria or if it is in the best medical 
interest of the subjects in question. 
In cases of voluntary subject withdrawal, all data collected from the time of informed consent to the 
time of voluntary withdrawal may be used. The General Data Protection Regulation (GDPR) process will 
be followed as applicable per country regulations. Withdrawn subjects will not be replaced. Enrollment 
will continue as per CIP definitions up to the predefined maximum number of subjects. 
All subjects will be followed per institutional standard of care after any withdrawal, discontinuation, or 
completion of the study follow-ups. 
The reason for study exit of all enrolled subjects will be documented on the applicable electronic case 
report form (eCRF). In the event the subject withdraws consent during the study, the date of withdrawal 
will be documented. If the study investigator voluntarily removes a subject from further study 
participation, supporting documentation must be in place for the rationale and date of removal. Every 
attempt will be made to contact subjects who are noncompliant. Subjects will be considered lost to 
follow-up once the following steps have been taken: 
• 
Three phone calls should be made to the subject. Each attempt should be clearly documented in the 
source documents and the response or lack thereof should be captured.  
• 
If there is no response to the phone calls, then a certified/registered letter should be written to the 
subject. A copy of the letter should be retained in the subject’s source document. 
• 
After a period of one week following completion of the above actions, the subject will be considered 
lost to follow-up. The sponsor should be notified and the Study Exit form should be completed.  

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10. Risks and Benefits 
10.1. Potential Risks 
The potential risks of the Emprint™ Ablation System have been described in the Risk Management 
Report for the Emprint Ablation System with Ablation Catheter and the Clinical Evaluation Report for the 
Covidien Emprint™ Ablation System and Accessories and are summarized briefly below. The clinical 
investigation has been designed to involve as little pain, discomfort, fear, and any other foreseeable risk 
as possible for the subjects, and both the risk threshold. The degree of distress are specifically defined in 
the clinical investigation plan and constantly monitored. 
10.1.1. 
Summary of Risk Management Report 
A clinical risk/benefit analysis evaluated whether the Emprint™ Ablation System with Ablation Catheter 
is likely to provide more benefit than harm. Listed below are the high-risk residual risks from the risk 
analysis. All of the residual risks listed below have been described in the literature as known and/or 
experienced complications of ablation procedures. All patients who undergo an ablation procedure are 
consented for such risks. Benefit estimation describes the expected performance of the device, 
expected clinical outcome, and risks and benefits related to other procedural options. The risk/benefit 
comparison documents the judgments of whether the benefits exceed the residual risks. 
• 
Pleural effusion 
• 
Intraparenchymal pulmonary hemorrhage / bronchopulmonary hemorrhage 
• 
Pain/shoulder pain 
• 
Mortality 
• 
Pyothorax 
• 
Atrial fibrillation 
• 
Hemolysis 
• 
Pulmonary/upper respiratory fistula 
• 
Hemothorax 
• 
Abscess 
• 
Hematoma 
• 
Hemoptysis 
• 
Pneumonia 
• 
Pulmonary edema 
• 
Ventricular arrhythmia 
• 
Unintended microwave burn – unintended tissue ablation 
• 
Unintended microwave burn – vessel thrombosis /thrombus /embolism 

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• 
Unintended microwave burn – diaphragmatic paresis 
Expected AE rates are described in Section 10.1.2 below. 
In accordance with the safety assessments described in Section 9.8.5, risks will be continuously 
monitored, assessed and documented by the investigator. 
10.1.2. 
Summary of Clinical Evaluation Report 
A Clinical Evaluation Report (CER) for the Covidien Emprint™ Ablation System and Accessories was 
performed according to the provisions of the Medical Devices Directive 93/42/EEC (MDD), as amended 
by Directive 2007/47/EC. This report was prepared in accordance with the following Guidelines and 
Standard Operating Procedures (SOPs) to provide evidence of the medical safety and performance of 
the Emprint™ Ablation System and Accessories for its intended use: MEDDEV 2.7/1 rev. 4 (June 2016), 
MEDDEV 2.12/2 rev. 2 (January 2012). The intent of this CER was to provide evidence that the Emprint™ 
Ablation System and Accessories are safe, effective, and state-of-the-art for the indications and 
intended use, through a critical review of product-related documents, testing, published clinical 
literature and post-market data. A brief summary of that report is included below. 
The safety of the Emprint™ Ablation System has been assessed in 8 clinical studies evaluating its use in 
the liver,18-23 pancreas,24 and lung,15 as well as complaints and vigilance reports of 27,150 devices sold. 
All complications occurred in < 1% of patients each (total complication rate 4.7%). This is comparable to 
or better than the 10.3% complication rate in the liver for minor and major complications reported in 
the literature. The majority of complications reported with use of microwave ablation in the lung (such 
as pneumothorax and hemorrhagic effusion) were from one clinical publication and one clinical 
investigation and are either known complications of microwave ablation or were deemed to not be 
related to the device or the procedure. In one clinical publication of microwave ablation in the pancreas, 
pain was the only complication reported. Pain is a common complication, and often resolves 
spontaneously or with treatment. 
In the post-market complaints and vigilances report spanning a 5-year period, all confirmed injuries are 
known to occur with microwave ablation. In addition, 5 of 7 deaths reported occurred in patients with 
major comorbidities. 
All complications that occurred with use of the Emprint™ MWA ablation system in the liver, lung, and 
pancreas are either known to occur with microwave ablation or were deemed to be unrelated. In 
addition, complications in the liver and lung occurred at similar rates to other microwave ablation 
devices reported in the literature. 
10.1.3. 
Radiation Exposure 
There are risks associated with the use of x-ray fluoroscopy,  CBCT, and CT imaging for this study.  

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The CT scan and the imaging that will be carried out as part of the ablation procedure are part of the 
patient’s routine care. These procedures use ionizing radiation to form images of the body and provide 
the doctor with other clinical information. Ionizing radiation can cause cell damage that may, after many 
years or decades, turn cancerous. The chances of this happening are the same whether patients take 
part in this study or not. It should be noted that radiation dose will vary based on the type of imaging 
system used and the size of the patient.  
10.2. Potential Benefits 
Benefit estimations of the general use of the Emprint™ Ablation Catheter with Thermosphere™ 
Technology are described in the Risk Management Report for the Emprint™ Ablation System with the 
Ablation Catheter.  
Microwave ablation is an alternative for patients with lung cancer who are either ineligible for or refuse 
other treatments such as surgical resection. Furthermore, bronchoscopic ablation may result in fewer 
complications than percutaneous ablation (see Section 4.1). For patients who are not candidates for 
alternative therapies, the benefits of microwave ablation outweigh the risks described above. 
The bronchoscopic ablation procedure described in this study is commercially available. Patients could 
receive these potential benefits without taking part in the study and may not gain any direct medical 
benefits compared to routine care. However, the data collected from this study will help characterize 
the safety and performance of the Emprint™ Ablation Catheter with Thermosphere™ Technology. If the 
results of this study support additional clinical research, further studies may be justified to evaluate the 
potential for improved standard-of-care using microwave ablation technology in lung nodules.  
10.3. Risk-Benefit Rationale 
As described in the Risk Management Report for the Emprint™ Ablation System with the Ablation 
Catheter, performing image-guided microwave ablation involves risk. Complications have been reported 
in the literature associated with thermal ablation of the lung. These complications are associated with 
both the intervention itself and patient comorbidity. For patients who are not candidates for alternative 
therapies, the benefits of microwave ablation described above outweigh these risks. 
11. Adverse Events and Device Deficiencies 
11.1. Definitions/Classifications 
Adverse event (AE) definitions used in this study are based on ISO 14155:2011 (Clinical Investigation of 
Medical Devices for Human Subjects -- Good Clinical Practice; 
https://www.iso.org/obp/ui/#iso:std:iso:14155:ed-2:v1:en), which is aligned with MEDDEV 2.7/3 

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Revision 3, May 2015 (Guidelines on Medical Devices, Clinical Investigations: Serious Adverse Event 
Reporting).  
For the purpose of this clinical study investigational plan, the point of enrollment is defined as the 
insertion of the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology into the EWC. AEs will 
be collected beginning at the point of enrollment. For safety reporting, only AEs related to the 
procedure or study devices will be captured and reported until the subject exits the study. Any 
unresolved procedural or device related events that are still ongoing past study exit will be monitored by 
the physician per their institutional standard-of-care.  
Anticipated AEs are listed in Section 10.1. 
AEs related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, accessory devices, 
or study procedures will be adjudicated by an independent medical monitor. 
Refer to the NAVABLATE Adverse Event Reference List (Appendix 17.5) for additional definitions. 
11.1.1. 
Adverse Event (AE) 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related to 
the investigational medical device.* 
*For the purposes of this clinical study, AE definitions will be ISO 14155:2011 compliant with the 
following exception:  only those AEs that are related to the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology, accessory devices, or study procedures will be captured and reported. 
NOTE 1: This definition includes events related to the investigational medical device or the comparator. 
NOTE 2: This definition includes events related to the procedures involved. 
NOTE 3: For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
11.1.2. 
Serious Adverse Event (SAE) 
For the purposes of this study, a Serious Adverse Event (SAE)* is an AE that has 
1. Led to death, 
2. Led to serious deterioration in the health of the subject, that either resulted in 
a. A life-threatening illness or injury, or 
b. A permanent impairment of a body structure or a body function, or 
c. In-patient or prolonged hospitalization, or 
d. Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function. 

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3. Led to foetal distress, foetal death or a congenital abnormality or birth defect 
NOTE 1: This includes device deficiencies that might have led to an SAE if a) suitable action had not been 
taken or b) intervention had not been made or c) if circumstances had been less fortunate. These are 
handled under the SAE reporting system.  
NOTE 2: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigational plan, without serious deterioration in health, is not considered an SAE. 
*For the purposes of this clinical study, SAE definitions will be ISO 14155:2011 compliant with the 
following exception:  only those SAEs that are related to the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology, accessory devices, or study procedures will be captured and reported. 
11.1.3. 
Adverse Device Effect (ADE) 
An Adverse Device Effect (ADE) is an AE related to the use of the investigational medical device (the 
Emprint™ Ablation Catheter Kit with Thermosphere™ Technology). 
NOTE 1:  This definition includes AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical 
device. 
NOTE 2:  This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
11.1.4. 
Serious Adverse Device Effect (SADE) 
A Serious Adverse Device Effect (SADE) is an adverse device effect that has resulted in any of the 
consequences characteristic of an SAE. 
11.1.5. 
Unanticipated Serious Adverse Device Effect (USADE) 
An Unanticipated Serious Adverse Device Effect (USADE) is defined as serious adverse device effect 
which by its nature, incidence, severity or outcome has not been identified in the current version of the 
Risk Management Report. 
NOTE:  Anticipated serious adverse device effect (ASADE) is an effect which by its nature, incidence, 
severity or outcome has been identified in the risk analysis report. 
11.1.6. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance. 
Note: Device deficiencies include malfunctions, use errors, and inadequate labelling. 

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11.1.7. 
Adverse Event Relationship Classification 
Causality assessments define the relationship between the use of the medical device (including the 
procedure) and the occurrence of each AE. During causality assessment activity, clinical judgment shall 
be used and the relevant documents, such as the MDR Reportable Event Trend & Risk Analysis Report 
shall be consulted, as all the foreseeable SAEs and the potential risks are listed and assessed there. The 
presence of confounding factors, such as concomitant medication/treatment, the natural history of the 
underlying disease, other concurrent illness or risk factors shall also be considered. 
Each AE and SAE will be classified according to five different levels of causality. The following definitions 
will be used to assess the relationship of the AE to the investigational medical device (the Emprint™ 
Ablation Catheter Kit with Thermosphere™ Technology), accessory devices, or study procedures: 
• 
Not related:  Relationship to the device or procedures can be excluded when: 
o the event is not a known side effect of the product category the device belongs to or of 
similar devices and procedures 
o the event has no temporal relationship with the use of the investigational device or the 
procedures; 
o the serious event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
o the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or increase of 
the level of activation/exposure), do not impact on the serious event; 
o the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
o the serious event can be attributed to another cause (e.g. an underlying or concurrent 
illness/ clinical condition, an effect of another device, drug, treatment or other risk factors); 
o the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable; 
o harms to the subject are not clearly due to use error; 
o In order to establish the non-relatedness, not all the criteria listed above might be met at 
the same time, depending on the type of device/procedures and the serious event. 
• 
Unlikely: The relationship with the use of the device seems not relevant and/or the event can be 
reasonably explained by another cause, but additional information may be obtained. 
• 
Possible:  The relationship with the use of the investigational device is weak but cannot be ruled 
out completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ 
clinical condition or/and an effect of another device, drug or treatment). Cases were relatedness 
cannot be assessed or no information has been obtained should also be classified as possible. 
• 
Probable:  The relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably be explained by another cause, but additional information may be 
obtained. 

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• 
Causal relationship:  The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 
o the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures; 
o the event has a temporal relationship with investigational device use/application or 
procedures; 
o the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
o the serious event follows a known response pattern to the medical device (if the response 
pattern is previously known); 
o the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
o other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out; 
o harm to the subject is due to error in use; 
o the event depends on a false result given by the investigational device used for diagnosis, 
when applicable; 
• 
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
Events will be distinguished between the SAEs related to the device and those related to the procedures 
(any procedure specific to the clinical investigation). An AE can be related both to procedures and the 
device. Complications of procedures are considered not related if the said procedures would have been 
applied to the patients also in the absence of device use/application. 
In some particular cases the event may be not adequately assessed because information is insufficient 
or contradictory and/or the data cannot be verified or supplemented. The sponsor’s Medical Monitor 
and the Investigators will make the maximum effort to define and categorize the event and avoid these 
situations. Where the Medical Monitor remains uncertain about classifying the serious event, it should 
not exclude the relatedness and classify the event as “possible”. 
11.1.8. 
Adverse Event Outcome Classification 
Outcome of the event will be defined according to the following:  
• 
Fatal:  If death was possibly, probably, or causally related to the event 
• 
Not recovered / not resolved:  Subject has exited the study and the AE is ongoing and not expected to 
resolve 
• 
Recovered / resolved:  The event has fully resolved prior to study exit 

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• 
Recovered / resolved with sequelae:  The event has resolved prior to study exit, but retained pathological 
conditions resulting from the prior disease or injury  
• 
Recovering / resolving:  The subject has exited the study and the AE is ongoing but expected to resolve 
• 
Unknown:  The subject has exited the study and the AE outcome is unknown 
11.2. Reporting of Adverse Events 
Assessment of the occurrence of an AE will be based on changes in the subject’s physical examination, 
laboratory results, and/or signs and symptoms. AEs will be monitored until a subject completes the 
study. Any unresolved procedural- or device-related events that are still ongoing past study exit will be 
monitored by the physician per their institutional standard-of-care. AEs will be documented in the 
applicable source documentation and reported on an AE eCRF. To the extent possible, the event to be 
recorded and reported is the event diagnosis as opposed to event outcome (e.g. death) or symptoms 
(e.g., fever, chills, nausea and vomiting in the presence of a clinically diagnosed infection is to be 
reported as infection only). 
The following should not be considered an AE: 
• 
A condition requiring a preplanned procedure unless the condition worsened since enrollment 
• 
A preexisting condition found as a result of screening, unless the condition has worsened since 
enrollment. 
11.2.1. 
Notification to Authorities 
The following events are generally considered reportable during the course of this study and should be 
reported within the timeframes outlined in Table 2: 
• 
any AE or SAE related to the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology, 
accessory devices, or study procedures  
• 
any Device Deficiency  
• 
new findings/updates in relation to already reported events.  
 

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Table 2. Reporting of Adverse Events 
Type 
Report to 
Reporting Timeframe (from time of 
learning of event) 
Device Deficiency  
Sponsor 
Recommended within 10 working days  
AE  
Sponsor 
Recommended within 10 working days 
EC/IRB 
Per EC/IRB reporting requirements 
SAE 
Sponsor 
Not to exceed 10 working days 
EC/IRB 
Per EC/IRB reporting requirements 
 
Events will be reviewed by sponsor or designee to determine any sponsor reporting obligations to 
Regulatory Authority and EC/IRB. All applicable events will be reported to Post-Market Vigilance (PMV) 
by sponsor clinical team; and PMV will also report to Regulatory Authorities when applicable. 
AEs will be recorded on the Adverse Event CRF. 
12. Data Review Committees  
There will be no Data Monitoring Committee or Clinical Events Committee as these are not required for 
a post-market study of a commercially available product. 
13. Statistical Design and Methods 
All statistical analyses will be performed using Statistical Analysis System (SAS) for Windows (version 9.4 
or higher, SAS Institute Inc. Cary, NC) or other widely accepted statistical or graphical software.  
Descriptive statistics will be used to present the data and to summarize the results. Continuous variables 
will be summarized with number of subjects (n), mean, standard deviation, median, and ranges. 
Categorical variables will be summarized by frequencies and percentages. 
The sample size of this study is not based on power calculations of a statistical hypothesis test.  
There are no pre-planned interim or subgroup analyses. Any post-hoc subgroup analyses will be 
exploratory in nature for the purpose of evaluating the safety and performance of the study device 
under various clinical conditions. 
Due to the post-market and observational nature of the study, no imputation is planned for missing data 
in the primary and secondary endpoints, if any. All available data from enrolled subjects will be 
reported.  

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A detailed Statistical Analysis Plan (SAP) will be prepared prior to data analysis.  
Any deviations from this analysis plan will be documented in the final clinical study report.  
14. Ethics 
14.1. Statement(s) of Compliance  
This clinical investigation will be conducted in accordance with this CIP, the ethical principles that have 
their origin in the Declaration of Helsinki, as well as with ISO 14155:2011 (Clinical Investigation of 
Medical Devices for Human Subjects – Good Clinical Practice), the European Union Medical Device 
Regulation, and the International Conference on Harmonisation (ICH) of Technical Requirements For 
Registration of Pharmaceuticals For Human Use, ICH Harmonised Tripartite Guideline for Good Clinical 
Practice E6 (R1).  This investigation will also be conducted per applicable local regulatory requirements 
and laws in which the study will be conducted. 
The study will be compliant with ISO 14155:2011 with the following exceptions: 
• 
The point of enrollment is defined as the insertion of the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology into the EWC, rather than at the time of informed consent. Subjects 
will be approached to obtain written informed consent prior to any institution non-standard-of-care 
assessments or study specific data being collected. Subjects who provide study consent but then are 
determined to be ineligible prior to the insertion of the ablation catheter will be considered screen 
failures and documented as such in the database (see Section 8.2). 
• 
For the purposes of this clinical study, AE definitions will be ISO 14155:2011 compliant with the 
following exception:  only those AEs deemed to be related to the Emprint™ Ablation Catheter Kit 
with Thermosphere™ Technology, accessory devices, or study procedures will be captured and 
reported (see Section 11.1.1). 
The principles of the Declaration of Helsinki have all been implemented by means of the patient 
informed consent process, EC approval, study training, clinical study registration, preclinical testing, risk 
benefit assessment, and publication policy.  
Pediatric, legally incompetent, or other vulnerable subjects are not eligible for the study.  
The clinical investigation will not begin until all necessary approvals/favorable opinions are obtained 
from the appropriate EC/IRBs or Regulatory Authority, as appropriate. Should an EC/IRB or regulatory 
authority impose any additional requirements, they will be followed.  
Information regarding the study and study data will be made available via publication on clintrials.gov. 
Additionally, the results of this study will be submitted for publication in an appropriate journal. 
No insurance or compensation will be provided to study subjects. 

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Medtronic maintains appropriate clinical study liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a clinical study insurance statement/certificate will be provided to the EC/IRB. 
15. Study Administration 
15.1. Monitoring  
Authorized Medtronic representatives will conduct site initiation visits prior to first subject enrolled at a 
site. Site initiation visits include activities such as verification that training was conducted and 
documented. 
Site monitoring visits will be conducted by an authorized Medtronic representative to inspect study 
data, subjects’ medical records, and CRFs in accordance with current ISO 14155 and ICH GCPs and the 
respective local and national government regulations and guidelines (if applicable). The study 
investigator and the investigating site will permit authorized clinical research personnel and clinical 
monitors from Medtronic and/or designee(s) employed by Medtronic to review completed CRFs, EC/IRB 
decisions, and Investigator, clinical site records, and facilities relevant to this study at regular intervals 
throughout the study per the monitoring plan. Additionally, subject charts and clinical records will be 
requested and reviewed so that protocol adherence and source documentation can be verified.  
The accuracy and quality of the data obtained from the investigator and maintained by the Sponsor will 
be confirmed through a structured program of clinical field auditing and internal review detailed in the 
monitoring plan. In instances where data protection regulations prohibit the direct examination of 
hospital records by the study Sponsor or designee(s), the Investigator will cooperate in a system of 
source data verification with the Sponsor. Monitoring may be performed with in person visits or 
remotely, when applicable.  
To ensure the rights, safety, and welfare of study subjects are being maintained, the monitor will 
maintain assurance that all study staff are trained on the CIP and use of the study devices. If the monitor 
discovers that an investigator is not complying with the signed Investigator Statement, the 
investigational plan, applicable laws, or any conditions of approval imposed by the reviewing EC/IRB or 
Regulatory Authority, the monitor will report to the Sponsor and take such steps necessary to promptly 
secure compliance. If compliance cannot be secured, the investigator’s participation in the investigation 
may be terminated.  
Because there are no required medications for this study or other subject-generated reporting 
requirements, monitoring of subject compliance is not applicable to this study. 
A minimum of 80% source data verification is required, though a higher percentage of verification will 
be attempted. All ICFs and eligibility criteria are required to be 100% source-data verified. 

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Authorized Medtronic representatives will also conduct site close-out visits. Site close-out visits include 
activities such as ensuring site files are complete and accurate, essential documents are collected, and 
reminding the site of their study closure responsibilities. 
15.2. Data Management 
This study will utilize an electronic database and eCRF. All data requested on the eCRF are considered 
required. Data points not collected and/or recorded will be considered deviations unless otherwise 
specified. No data points will be collected directly on the eCRF. 
In order to accurately collect all information, subject worksheets may also be provided for study specific 
data (e.g. specific nodule and procedure data points, etc.) not found in the medical records and will be 
considered the source document.  
The Principal Investigator must ensure the accuracy and completeness of the recorded data and then 
provide his/her electronic signature on the appropriate CRFs. The Investigator’s signature for specific 
CRFs will be documented in compliance with local regulations. Changes to data previously submitted to 
the sponsor will require a new electronic signature by the Investigator to acknowledge/approve the 
changes. 
Visual and/or computer data review will be performed to identify possible data discrepancies. Manual 
and/or automatic discrepancies will be created in the Oracle remote data capture (RDC) system and will 
be issued to the site for appropriate response. The site staff will be responsible for resolving all 
discrepancies in the database. 
15.3. Direct Access to Source Data/Documents  
The investigator(s)/institution(s) will permit inspection and study-related monitoring, audits, IRB/IEC 
review, and regulatory inspection(s), including direct access to source data/documents per applicable 
laws and regulations.  
15.4. Confidentiality 
All records identifying the subject will be kept confidential and, to the extent permitted by the 
applicable laws and/or regulations, will not be made publicly available.  
Subject names will be kept confidential. Only the subject number will be recorded in the CRF, and if the 
subject name appears on any other document, it must be removed.  
Study findings stored on a computer will be stored in accordance with local data protection laws. The 
subjects will be informed in writing that representatives of the sponsor, IRBs, or Regulatory Authorities 
may inspect their medical records to verify the information collected, and that all personal information 

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made available for inspection will be handled in strictest confidence and in accordance with local data 
protection laws.  
Subjects will also be informed that information regarding the study that does not include subject 
identifiers will be posted on www.clinicaltrials.gov. 
If the results of the trial are published, the subject’s identity will remain confidential.  
15.5. Liability 
Medtronic maintains appropriate clinical study liability insurance coverage as required under applicable 
laws and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a clinical study insurance statement/certificate will be provided to the EC/IRB.  
15.6. CIP Amendments 
Should any amendment to the CIP be required, the CIP Author will collect and review all proposed 
updates. These will be incorporated as needed and approved per the CIP Approval Process, including 
EC/IRB approval and Regulatory Authority. 
15.7. Record Retention 
The investigator will maintain the records of the study including all pertinent correspondence, the CIP 
with any/all amendments, all correspondence with and approval from the EC/IRB, the clinical 
investigation agreement, the Investigator Agreement, individual subject records, and signed ICFs. 
Subject files and other source data must be maintained per required storage periods defined by the 
applicable laws.  
Records may need to be maintained by the study investigator for a longer duration if agreed to in 
writing with Medtronic. All data and documents should be made available if requested by relevant 
authorities.  
15.8. Publication and Use of Information 
The Medtronic Publication and Authorship Policy is aligned with the International Committee of Medical 
Journal Editors (ICMJE) recommendations (www.icmje.org). The Sponsor will seek to publish, in 
appropriate peer-reviewed journals and scientific conferences, results of clinical studies where human 
subjects are involved, regardless of outcome. While study results are owned by the Sponsor, all data on 
which a publication is based will be made available to all authors as required for their participation in 
the publication process. Furthermore, data may be published or used by study investigators provided 
that such publication or use is in accordance with this protocol, the Medtronic Publication and 
Authorship Policy, and the Clinical Investigation Agreement. Investigators must submit a copy of all 

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manuscripts and/or abstracts to the Sponsor for review and comment at least 30 days prior to the 
planned submission. Medtronic acknowledges that its right to review and comment shall relate solely to 
the proprietary, licensing, and/or confidential rights Medtronic may have in such proposed publication, 
rather than whether such results and/or opinions are favorable to Medtronic.  
The publication of substudies, post-hoc analyses, regional results, or single-center experiences based on 
multicenter clinical studies should not precede that of the primary multicenter publication, and should 
cite the primary publication whenever possible, as required by specific journal and scientific meeting 
guidelines.  
Medtronic involvement in a publication (e.g., funding of the study; sponsor of the study; collection, 
analysis, and interpretation of data; professional writing assistance) must be disclosed according to 
journal-specific policies, submission requirements, and prevailing editorial standards, in addition to 
those specified by International Committee of Medical Journal Editors. Authors must ensure that an 
acknowledgement/disclosure statement is included in the body of the manuscript for Medtronic to 
review for accuracy. All authors must also disclose financial or personal affiliations that could be 
considered conflicts of interest as per journal/conference requirements. 
To enable health care providers, payers, and patients access to the wealth of Medtronic’s research, 
Medtronic will report its scientific data in accordance with the principles outlined in the Guidance 
Document on Registration and Reporting Results of Company-Sponsored Clinical Trials, Section 801 of 
the Food and Drug Administration Amendments Act (FDAAA 801) and the Final Rule for Clinical Trials 
Registration and Results Information Submission (42 CFR Part 11, January 18, 2017). 
15.9. Suspension or Early Termination 
At the time of a study close-out, the investigators will be notified by the sponsor. Appropriate 
notification and the final study report will be provided to EC/IRB and Regulatory Authority, if required 
per local laws and regulations. 
Medtronic reserves the right to discontinue the study at any stage, with suitable written notice to the 
investigator, the reviewing EC/IRB, and applicable Regulatory Authority. Similarly, the investigator may 
withdraw from the study at any time, subject to providing written notification to Medtronic 30 days 
prior to the date they intend to withdraw. However, Medtronic and the investigator will be bound by 
their obligation to complete the follow-up of subjects already participating in the study. The subjects 
must be followed according to the clinical protocol, and information obtained shall be reported to 
Medtronic on the appropriate CRF.  
 

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15.10. 
Study Contact Information 
Medtronic Clinical Research 
Medtronic Medical Affairs 
 
 
 
 
 
Jennifer Mattingley MD 
Medical Affairs Director 
MITG,  Surgical Innovations, Lung Health 
161 Cheshire Lane, Suite 100 
Plymouth, MN 55441 
 
Jennifer Wolvers 
Clinical Research Manager 
MITG,  Surgical Innovations, Lung Health 
161 Cheshire Lane; Suite 10 
Plymouth, MN 55441 
 
 
 
 
15.11. 
Financial Information 
Medtronic contracts with participating institutions/investigators through a Clinical Trial Agreement that 
defines the scope and responsibilities and associated compensation related to carrying out the 
obligations under a clinical study sponsored by Medtronic.  
16. References 
1. National Cancer Institute, Cancer Therapy Evaluation Program, United States Department of Health 
and Human Services, National Institutes of Health. Common Terminology Criteria for Adverse Events 
(CTCAE) Version 5.0. Available at: 
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50. Accessed 
January 23, 2018. 
2. Ahmed M, Solbiati L, Brace CL, Breen DJ, Callstrom MR, Charboneau JW, et al. Image-guided tumor 
ablation: standardization of terminology and reporting criteria--a 10-year update. J Vasc Interv 
Radiol. 2014;25(11):1691-705 e4. doi: 10.1016/j.jvir.2014.08.027. PubMed PMID: 25442132. 
3. National Comprehensive Cancer Network. Non–Small Cell Lung Cancer, Version 3.2018, NCCN 
Clinical Practice Guidelines in Oncology. National Comprehensive Cancer Network. 2018. 
4. Hinshaw JL, Lubner MG, Ziemlewicz TJ, Lee FT, Jr., Brace CL. Percutaneous tumor ablation tools: 
microwave, radiofrequency, or cryoablation-what should you use and why? Radiographics. 
2014;34(5):1344-62. doi: 10.1148/rg.345140054. PubMed PMID: 25208284. 

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5. Roberton BJ, Liu D, Power M, Wan JM, Stuart S, Klass D, et al. Pulmonary ablation: a primer. Can 
Assoc Radiol J. 2014;65(2):177-85. doi: 10.1016/j.carj.2013.01.003. PubMed PMID: 23942193. 
6. Dupuy DE. Image-guided thermal ablation of lung malignancies. Radiology. 2011;260(3):633-55. doi: 
10.1148/radiol.11091126. PubMed PMID: 21846760. 
7. Dupuy DE, Zagoria RJ, Akerley W, Mayo-Smith WW, Kavanagh PV, Safran H. Percutaneous 
radiofrequency ablation of malignancies in the lung. AJR Am J Roentgenol. 2000;174(1):57-9. doi: 
10.2214/ajr.174.1.1740057. PubMed PMID: 10628454. 
8. Howington JA, Blum MG, Chang AC, Balekian AA, Murthy SC. Treatment of stage I and II non-small 
cell 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):e278S-313S. doi: 
10.1378/chest.12-2359. PubMed PMID: 23649443. 
9. Lanuti M, Sharma A, Willers H, Digumarthy SR, Mathisen DJ, Shepard JA. Radiofrequency ablation for 
stage I non-small cell lung cancer: management of locoregional recurrence. Ann Thorac Surg. 
2012;93(3):921-7; discussion 7-88. doi: 10.1016/j.athoracsur.2011.11.043. PubMed PMID: 
22296982. 
10. Casal RF, Tam AL, Eapen GA. Radiofrequency ablation of lung tumors. Clin Chest Med. 
2010;31(1):151-63. doi: 10.1016/j.ccm.2009.08.021. PubMed PMID: 20172441. 
11. de Baere T, Deschamps F. New tumor ablation techniques for cancer treatment (microwave, 
electroporation). Diagnostic and interventional imaging. 2014;95(7-8):677-82. doi: 
10.1016/j.diii.2014.04.001. PubMed PMID: 24818966. 
12. Howk K, Ladtkow C, Peterson D, Cafaro A. Consistent and Predictable Spherical Ablation Shape in 
Both Liver and Lung: Performance of the Emprint Ablation System with Thermosphere Technology in 
an In Vivo Porcine Model [Poster 129]. J Vasc Interv Radiol. 2015;26(5):e89-e90. 
13. Howk K, Ladtkow C, Peterson D, Cafaro A. Performance of the Emprint™ Ablation System in an In 
Vivo Porcine Lung Model: Correlation between CT and Gross Measurements [Poster 131]. J Vasc 
Interv Radiol. 2015;26(5):e91. 
14. Alonzo M, Bos A, Bennett S, Ferral H. The Emprint Ablation System with Thermosphere Technology: 
One of the Newer Next-Generation Microwave Ablation Technologies. Semin Intervent Radiol. 
2015;32(4):335-8. doi: 10.1055/s-0035-1564811. PubMed PMID: 26622094; PubMed Central PMCID: 
PMC4640908. 
15. Ierardi AM, Coppola A, Lucchina N, Carrafiello G. Treatment of lung tumours with high-energy 
microwave ablation: a single-centre experience. Medical oncology. 2017;34(1):5. doi: 
10.1007/s12032-016-0861-6. PubMed PMID: 27900591. 
16. Gex G, Pralong JA, Combescure C, Seijo L, Rochat T, Soccal PM. Diagnostic yield and safety of 
electromagnetic navigation bronchoscopy for lung nodules: a systematic review and meta-analysis. 
Respiration. 2014;87(2):165-76. doi: 10.1159/000355710. PubMed PMID: 24401166. 
17. Heerink WJ, de Bock GH, de Jonge GJ, Groen HJ, Vliegenthart R, Oudkerk M. Complication rates of 
CT-guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017;27(1):138-48. doi: 
10.1007/s00330-016-4357-8. PubMed PMID: 27108299; PubMed Central PMCID: PMC5127875. 

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18. Berber E. The first clinical application of planning software for laparoscopic microwave 
thermosphere ablation of malignant liver tumours. HPB (Oxford). 2015;17(7):632-6. doi: 
10.1111/hpb.12423. PubMed PMID: 25980481; PubMed Central PMCID: PMC4474511. 
19. Ierardi AM, Mangano A, Floridi C, Dionigi G, Biondi A, Duka E, et al. A new system of microwave 
ablation at 2450 MHz: preliminary experience. Updates in surgery. 2015;67(1):39-45. Epub March 
17. doi: 10.1007/s13304-015-0288-1. PubMed PMID: 25776064. 
20. De Cobelli F, Marra P, Ratti F, Ambrosi A, Colombo M, Damascelli A, et al. Microwave ablation of 
liver malignancies: comparison of effects and early outcomes of percutaneous and intraoperative 
approaches with different liver conditions: New advances in interventional oncology: state of the 
art. Medical oncology. 2017;34 (4) (no pagination)(49). doi: 10.1007/s12032-017-0903-8. 
21. Floridi C, Radaelli A, Pesapane F, Fumarola EM, Lecchi M, Agostini A, et al. Clinical impact of cone 
beam computed tomography on iterative treatment planning during ultrasound-guided 
percutaneous ablation of liver malignancies. Medical oncology. 2017;34 (6) (no pagination)(113). 
doi: 10.1007/s12032-017-0954-x. 
22. Takahashi H, Kahramangil B, Berber E. Local recurrence after microwave thermosphere ablation of 
malignant liver tumors: Results of a surgical series. Surgery. 2017. doi: 10.1016/j.surg.2017.10.026. 
23. Vogl TJ, Basten LM, Nour-Eldin NA, Kaltenbach B, Bodelle B, Wichmann JL, et al. Evaluation of 
microwave ablation of liver malignancy with enabled constant spatial energy control to achieve a 
predictable spherical ablation zone. International journal of hyperthermia : the official journal of 
European Society for Hyperthermic Oncology, North American Hyperthermia Group. 2017:1-9. doi: 
10.1080/02656736.2017.1358408. PubMed PMID: 28774210. 
24. Vogl TJ, Panahi B, Albrecht MH, Naguib NNN, Nour-Eldin NA, Gruber-Rouh T, et al. Microwave 
ablation of pancreatic tumors. Minim Invasive Ther Allied Technol. 2018;27(1):33-40. doi: 
10.1080/13645706.2017.1420664. PubMed PMID: 29278340. 
25. Steinfort DP, Einsiedel P, Irving LB. Radiation dose to patients and clinicians during fluoroscopically-
guided biopsy of peripheral pulmonary lesions. Respir Care. 2010;55(11):1469-74. Epub 2010/10/29. 
PubMed PMID: 20979674. 
26. Hohenforst-Schmidt W, Banckwitz R, Zarogoulidis P, Vogl T, Darwiche K, Goldberg E, et al. Radiation 
exposure of patients by cone beam CT during endobronchial navigation-a phantom study. J Cancer. 
2014;5(3):192. 
 
 
 
 

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17. Appendices  
17.1. User Manual 
See attached document, “Appendix 17.1_User Manual” for the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology Bronchoscopic Ablation Instructions for Use (CA108L1). 
17.2. Product Label 
See attached document, “Appendix 17.2_Product Label” for the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology Bronchoscopic Ablation Shipping Label (CA108L1). 
17.3. Bronchoscopic Ablation Patient Satisfaction and Pain Survey 
See attached document, “Appendix 17.3_Patient Satisfaction and Pain”  
17.4. Quality of Life Questionnaire 
See attached document, “Appendix 17.4_Quality of Life (EQ-5D)”  
17.5. NAVABLATE Adverse Event Reference List 
See attached document, “Appendix 17.5_NAVABLATE Adverse Event Reference List”  
17.6. Sample Informed Consent Form 
See attached document, “Appendix 17.6_NAVABLATE Sample ICF”  
 
18. Version History 
Version 
History 
Summary of Changes 
Author(s)/Title 
1.0 
• 
Not applicable (new document) 
Jennifer Wolvers, Principal Clinical 
Research Specialist 
Kristin Hood, Senior Principal Medical 
Writer 
2.0 
• 
To Appendix 17.3, added MRC 
Breathlessness Scale 
Jennifer Wolvers, Principal Clinical 

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Research Specialist 
Kristin Hood, Senior Principal Medical 
Writer 
3.0 
Requested updates per radiation expert. 
• 
To Table 1:  Added standard of care CT 
scan at baseline, noting this is already 
done prior to consent. 
• 
Modified section 10.1.3 “Radiation 
Exposure” to be more generalizable. 
Jennifer Wolvers, Principal Clinical 
Research Specialist 
Kristin Hood, Senior Principal Medical 
Writer 
4.0 
• 
Updated to most current version of 
056-F275, version A, Clinical 
Investigation Plan Template (no 
required changes other than updating 
footnote). 
• 
Updated names, addresses, and titles 
of sponsor and study contacts on Title 
page, and in Section 3 and 15.10 
• 
Added name and address of co-lead 
principal investigator (Dr. Calvin Ng) to 
the title page 
• 
Added most current IFU to Appendix 
17.1 
• 
Corrected typo in Appendix 17.5, 
NAVABLATE Adverse Event Reference 
List 
• 
Added Section 17.6, Sample Informed 
Consent Form 
 
The following updates were made for 
compliance to the European Union 
Medical Device Regulation (EU MDR): 
• 
Added name and address of Europe 
Authorized Representative to the title 
page, Section 1, and Section 3. 
• 
Added statement of compliance to the 
EU MDR to Section 1 and Section 14.1 
• 
Added EU MDR, IFU, and PMV to 
Section 2.1 
• 
Added statement to Section 3 
Jennifer Wolvers, Clinical Research 
Manager 
Kristin Hood, Senior Principal Medical 
Writer 

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regarding device use per the IFU 
• 
Added statement to Section 3 that 
there is no required number of 
subjects and 20 is the approximated 
minimum 
• 
Added statement to Section 7.1 
indicating that the device is used for 
the ablation of lung tissue 
• 
Added statement to Section 7.1 
regarding anticipated product changes 
• 
Added statement to Section 7.4 that 
products are packaged and labeled 
accordingly 
• 
Added statement to Section 7.5 
regarding the population of patients 
being evaluated 
• 
Statement added to Section 7.6 
allowing use of the CrossCountry™ 
Transbronchial Access Tool to obtain 
access 
• 
Added statement that no CIP waivers 
will be granted to Section 9.10 
• 
Added statement to Section 9.10 to 
address how study deviations will be 
reported to the Regulatory Authority 
• 
Added statement to Section 9.11 
indicating that standard of care will be 
followed for all subjects after 
withdrawal, discontinuation, or 
completion of the study follow-ups 
• 
Added statement to Section 10.1 that 
the study has been designed to have 
as little foreseeable risk as possible for 
patients 
• 
Added foetal events Serious Adverse 
Event definition in Section 11.1.2 
• 
Added definition of an anticipated 
serious adverse device effect to 
Section 11.1.5 
• 
Added statement to Section 11.2.1 

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that applicable events will be reported 
to PMV, who will report necessary 
events to Regulatory Authorities 
• 
Updated record retention period to be 
per applicable laws rather than 
defined timeframe in Section 15.7 
• 
Statement added to Section 15.9 
regarding the notification of the final 
study report 
• 
Added Section 15.11 regarding 
financial information 
 

en
Instructions for Use
Ablation Catheter Kit with Thermosphere™ Technology
CA108L1
Emprint
TM
Bronchoscopic Ablation
fr
Instructions d'utilisation
de
Gebrauchsanleitung
es
Instrucciones de uso
it
Istruzioni per l'uso
nl
Gebruiksaanwijzing
sv
Bruksanvisning
da
Brugsanvisning
no
Bruksanvisning

1
en
Symbols on Product and Packaging
The following symbols may appear on product or packaging:
Sterile using ethylene oxide
Not made with natural rubber latex
Single use
Federal law (USA) restricts this device to sale by or on the order of a physician
Do not resterilize
Do not use if package is opened or damaged
Type BF applied part
Consult instructions for use
Keep dry
Catalog number
Manufacturer
Use by
Batch code
Date of manufacture
China RoHS (reduction of hazardous substances)
Authorized representative in the European Community
CE mark. Designates that the product is authorized for sale in European countries

2
en
Device Description
Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology is for use with the 
Emprint™ Ablation System with Thermosphere™ 
Technology for the ablation of lung tissue.
1
Intravenous (IV) bag spike
2
Drip chamber
3
Pump tubing (orange)
4
Generator connector
5
Ablation catheter handle
6
Top groove
7
Control ring
8
Radiating section
9
Clip
Rail
The Emprint ablation catheter kit is designed for 
use with:
• Emprint Ablation Generator (required)
• Emprint Ablation Pump (required)
• Emprint Ablation Cart (required)
• Edge™ or Edge™ Firm Tip 
Extended Working Channel (required)
• Edge Bronchoscope Adapter (required)
• Ablation Footswitch (optional)
• 1 liter saline (required)
Indication for Use
The Emprint™ Ablation System with 
Thermosphere™ Technology is intended for use 
in percutaneous, laparoscopic, endoscopic, and 
intraoperative coagulation (ablation) of soft 
tissue, including partial or complete ablation of 
non-resectable liver tumors.
The Emprint™ Ablation System with 
Thermosphere™ Technology is not intended for 
use in cardiac procedures.
Contraindications
Do not defibrillate a patient with an ablation 
catheter inserted. Completely remove the 
catheter from the patient prior to defibrillation.
Microwave ablation procedures are not 
recommended for pregnant patients or 
patients with cardiac pacemakers or implanted 
electronic devices. Potential risks to the patient 
or fetus have not been evaluated.
Parts of the body of the patient containing 
metallic implants should not be treated unless 
specialized medical advice is obtained.
Warning
The ablation catheter kit is supplied sterile. 
Do not resterilize.
Do not use this device if it appears to be 
damaged.
Emprint
TM Ablation Catheter Kit with 
Thermosphere™ Technology
Bronchoscopic Ablation
CA108L1
1.8 cm
3 cm
0.4 cm
3 cm
1
8
8
4
9
10
7 
6
5
3
2

3
en
Warning
This device has been validated and 
warranted for single-use only. Any re-use, 
reprocessing, or re-sterilization could result 
in device failure causing patient or user 
injury, illness, or death. Re-use, reprocessing, 
or re-sterilization could cause contamination 
of the device, which could result in patient 
infection.
Be careful when creating ablation zones 
near critical structures including but not 
limited to large vasculature, heart, pleural 
boundary, esophagus, ductal structures, and 
the diaphragm.
Do not touch the catheter radiating section 
at any time during the application of energy.
During energy delivery, ensure that the 
ablation catheter radiating section does 
not come in contact with tissue other than 
the intended target, as inadvertent thermal 
injury may occur. 
Do not activate the ablation catheter while 
the radiating section is in contact with 
metal objects or instruments, as inadvertent 
thermal injury may occur.
Fire/Explosion Hazard: Do not use the 
Emprint ablation system in potentially 
flammable or explosive room 
environments.
The following substances will contribute to 
increased fire and explosion hazards in the 
operating room:
• Flammable substances such as flammable 
anesthetics or alcohol-based skin prepping 
agents and tinctures
• Oxygen enriched atmospheres
• Oxidizing agents such as nitrous oxide (N2O)
atmospheres
 
Heating associated with microwave energy 
can provide an ignition source. Observe 
fire precautions at all times. When using 
microwave energy in the same room with 
any of these substances or gases, prevent 
their accumulation or pooling under surgical 
drapes, or within the area where microwave 
procedures are performed.
Do not look into or place the ablation 
catheter radiating section near eyes or testes 
when energized, as this may result in burns or 
other injuries to the patient or user.
Before use with a bronchoscope, verify 
compatibility and any criteria for safe use 
defined in the bronchoscope’s instructions 
for use. 
Ensure that the bronchoscope is either a Type 
BF or Type CF applied part.
When energized bronchoscopes are used 
with energized endotherapy devices, patient 
leakage currents may be additive.
Precaution
The Emprint ablation catheter kit should 
only be used by clinicians and staff properly 
trained in the use of this technology and its 
associated warnings and cautions. Clinicians 
should also be trained in the use of image 
guidance technology such as computed 
tomography (CT) or cone beam CT for the 
placement of ablation devices.
Storage
• Store ablation catheters away from moisture 
and direct heat.
• Discard products that have passed the use by 
date displayed on product packaging.
Inspection of Package Contents
Examine the package carefully before opening 
to confirm its integrity and that the use by date 
has not passed. Do not use the device if the 
package is damaged or opened or if the use by 
date has passed.
Instructions for Use
Procedure Setup
Precaution
The Emprint ablation generator, Emprint 
ablation pump, Emprint ablation catheter kit, 
and Emprint ablation cart are designed for 
use as a single system.
Failure to understand and follow provided 
instructions may result in improper 
functioning of the system and cause injury to 
the patient or user.
The Emprint ablation cart, including the 
isolation transformer, must be included in 
the system setup with the Emprint ablation 
catheter kit. 
Important
Refer to the Emprint™ Ablation System with 
Thermosphere™ Technology User’s Guide for 
detailed instructions regarding proper setup 
and activation of the Emprint generator and 
pump.
For ease of use, only remove portions of the 
device from the packaging tray as instructed 
below. The ablation catheter packaging is 
designed so that the catheter components 
can remain in the packaging until each is 
needed.
1. 
Confirm that the Emprint generator 
and Emprint pump are set up according 
to the Emprint™ Ablation System with 
Thermosphere™ Technology User’s Guide.
2. 
Plug in the Emprint system.
3. 
Remove the rail from the packaging tray and 
then disconnect the tray lid.

4
en
4. 
Place the ablation catheter packaging on top 
of the Emprint cart as shown in Figure 1.
Figure 1
5. 
Hang a 1L or larger, room temperature sterile 
saline bag on the Emprint cart. A hook is 
provided on the left side of the cart.
6. 
Remove the white cap from the IV bag spike 
on the device tubing.
7. 
Fully insert the IV bag spike into the port 
on the saline bag. Confirm the IV bag spike 
extends well into the main reservoir of the IV 
bag as shown in Figure 2.
Figure 2
8. 
Prime the drip chamber by gently squeezing 
its sides until it is approximately half full of 
saline. The blue indicator should be floating 
near the surface of the saline.
9. 
Open the clear pump-head door and insert 
the orange pump tubing under the pump 
roller and into the pump roller clamps. Match 
the arrows on the pump tubing with the 
arrows on the pump head.
10. Close the pump-head cover completely. If 
the cover is not completely closed, the pump 
will not operate.
11. Grasp and push the generator connector to 
attach it to the front panel of the Emprint 
generator.
12. Activate the pump by pressing the activation 
switch on the pump’s front panel.
13. Allow the pump to fully prime the ablation 
catheter with saline before continuing with 
the procedure. The catheter is fully primed 
when there are no air bubbles observed 
entering the IV bag.
Precaution
When the pump is activated, ensure that 
saline flowing to the catheter is constantly 
dripping into the drip chamber. The pump 
circulates saline through the ablation 
catheter and back into the IV bag. Failure 
to circulate saline may result in heating of 
the ablation catheter that could prevent the 
system from operating properly.
Precaution
If the pump is active and the saline is not 
flowing, the tubing may be damaged or 
blocked.
Stop the pump and perform the following 
troubleshooting steps:
• Confirm that the direction of the orange 
tubing arrows align with the pump head 
arrows.
• Confirm that the IV bag spike is inserted 
well into the main reservoir of the IV bag 
(Figure 2).
• Remove and reinsert the orange pump 
tubing to ensure proper seating of the 
pump tubing in the pump roller clamps.
Restart the pump. If saline is still not flowing, 
replace the ablation catheter.
If any portion of the setup is leaking after 
troubleshooting, replace the ablation 
catheter.
14. On the Emprint generator panel, press the 
power switch to turn on the generator.
Warning
Do not activate microwave energy until 
setup is complete and the ablation catheter 
radiating section is fully inserted into tissue.
Important
If the Emprint generator displays an error 
during startup, confirm that the ablation 
catheter generator connector is properly 
mated to the generator front panel. Refer 
to the troubleshooting information in the 
Emprint™ Ablation System with Thermosphere™ 
Technology User’s Guide for additional 
information.
Placing the Ablation Catheter
1. 
Place the Edge extended working channel 
in the desired location and confirm with 
imaging. 
2. 
Tighten the Edge bronchoscope adapter 
prior to inserting the ablation catheter.
3. 
Attach the rail to the bronchoscope adapter 
as shown in Figure 3. Align the ridge on the 
bronchoscope adapter with the indent on 
the rail and snap into place.

5
en
Precaution
Do not attempt to manually bend or reshape 
the ablation catheter. Be careful not to kink 
the device as product damage or malfunction 
may result.
4. 
Depress the latch on the ablation catheter 
handle and remove the protective tube. 
Check the ablation catheter radiating section 
and ensure that there are no rough surfaces, 
sharp edges, or protrusions.
5. 
Using short, 2 cm strokes, insert the ablation 
catheter into the extended working channel. 
Observe the last 3 cm of the ablation 
catheter insertion using image guidance to 
ensure that the ablation catheter:
• remains sheathed in the extended 
working channel.
• is not severely bent or broken during 
insertion.
6. 
Insert the ablation catheter into the 
extended working channel until the 
ablation catheter handle latch locks with the 
extended working channel handle. When 
fully inserted, the ablation catheter tip may 
protrude slightly from the distal end of the 
extended working channel.
7. 
Slide the ablation catheter clip onto the rail.
8. 
Attach the ablation catheter clip to the top 
groove on the ablation catheter handle. 
Refer to Figure 3.
9. 
Verify that a portion of the rail is extending 
above the top of the clip. This will ensure that 
the extended working channel is adequately 
extended outside of the bronchoscope after 
unsheathing.
10. Lock the ablation catheter clip to fix the 
ablation catheter to the bronchoscope. The 
device setup should now look like the setup 
shown in Figure 3, A (control ring down and 
lock symbols visible).
11. Open the bronchoscope adapter to allow 
movement of the extended working channel 
in order to unsheathe the ablation catheter.
12. While using image guidance to monitor the 
ablation catheter's position, grasp and slide 
the ablation catheter control ring upward to 
retract the extended working channel and 
unsheathe the ablation catheter radiating 
section. Slide the control ring up until it 
clicks into place. Refer to Figure 3, B and B1.
13. Use image guidance to confirm that:
• the distal end of the extended working 
channel is extended beyond the 
bronchoscope (the dark blue portion of 
the extended working channel should be 
visible on the bronchoscope view).
• the ablation catheter radiating section 
is outside of the extended working 
channel.
• the ablation catheter radiating section is 
fully inserted into the target tissue.
Precaution
Failure to ensure that the extended working 
channel and ablation catheter radiating 
section is adequately extended beyond 
the bronchoscope may damage the 
bronchoscope.
14. If any ablation catheter forward adjustment 
is required, pull the control ring down 
to sheathe the ablation catheter before 
attempting to adjust the location. Refer to 
Figure 3, A1.
15. Tighten the bronchoscope adapter.
A
B
A1
A1
B1
Figure 3
Precaution
Full retraction of the extended working 
channel is necessary to expose the entire 
ablation catheter radiating section to the 
tissue. Ensure that the ablation catheter 
handle locks into the unsheathed position 
prior to activation as shown in Figure 3, B.
The ablation catheter is not designed to 
penetrate tissue beyond the Edge extended 
working channel. Proper use requires 
retraction of the extended working channel 
to unsheathe the ablation catheter radiating 
section.

6
en
Activating the Ablation Catheter
Warning
Confirm that the ablation catheter radiating 
section is in direct contact with target tissue 
or tightly wedged into a peripheral airway 
(no air around the radiating section). Failure 
to do so may result in unintended thermal 
injury or alter the ablation zone.
1. 
Set the Emprint generator’s power setting 
and activation time. Refer to the Ablation 
Zone Examples section for guidance on 
power and time settings. 
Important
If the power and time displays do not adjust, 
confirm proper connection between the 
ablation catheter generator connector and 
the Emprint generator front panel. Note 
that the Emprint ablation catheter limits 
the Emprint generator to a maximum of 100 
watts and 10 minutes.
If the Emprint generator displays a symbol, 
refer to the Emprint™ Ablation System with 
Thermosphere™ Technology User’s Guide for 
symbol descriptions and instructions.
2. 
Press the Emprint generator START/STOP 
button or press the footswitch to activate 
microwave energy to the ablation catheter. 
Important
Pressing the START/STOP button immediately 
stops energy delivery in an emergency.
3. 
Use image guidance to:
• confirm that the ablation catheter 
radiating section is not displaced during 
activation.
• monitor ablation zone formation.
Removing the Ablation Catheter
1. 
When ablation catheter energy delivery is 
complete, open the bronchoscope adapter 
to allow movement of the extended working 
channel.
2. 
Grasp and pull down the control ring until 
it clicks into place to sheathe the radiating 
section.
3. 
Tighten the bronchoscope adapter.
4. 
Unlock the ablation catheter clip, disconnect 
the clip from the top groove, and remove it 
from the rail.
5. 
Depress the latch on the ablation catheter 
and remove the ablation catheter from the 
extended working channel.
Warning
Do not clean the ablation catheter with any 
sharp or abrasive objects as damage to the 
catheter may occur, potentially resulting in 
saline leakage and possible patient injury.
6. 
If ablating another target area, ensure 
that no rough surfaces are present on the 
ablation catheter prior to re-insertion.
7. 
To avoid an Emprint generator temperature 
shutoff error, connect a new, room 
temperature 1L or larger sterile saline bag to 
the system prior to every ablation.
After a Procedure
1. 
Verify that the Emprint generator is not 
delivering microwave energy to the ablation 
catheter.
2. 
Press the pump activation switch to turn off 
the pump operation.
3. 
Press the Emprint generator power switch to 
turn it off.
4. 
Open the pump head and remove the pump 
tubing.
5. 
Disconnect the used ablation catheter from 
the Emprint generator. Twist and pull the 
generator connector to remove it from the 
front panel.
6. 
Dispose of the ablation catheter and saline 
IV bag in accordance with hospital or clinic 
protocol.
Further Information
The Emprint™ Ablation System with 
Thermosphere™ Technology User’s Guide provides 
additional information about the Emprint 
ablation system components. Refer to the user’s 
guide for information regarding:
• Using the system
• Other component functions
• Disposal
• Troubleshooting
• Technical specifications
• Technical support

7
en
Ablation Zone Examples
The ablation zone results examples contained in Table 1 were developed using the ablation catheter 
kit in an in vivo porcine lung. The table includes the ablation diameter (A), height (B), and distance 
from the tip (C) versus time (MM:SS) for three power levels (45 watts, 75 watts, and 100 watts).
The circular areas in Figure 4 represent the zone of tissue coagulation created around the ablation 
catheter radiating section. The shape and size of ablation zones may vary in clinical settings.
45 W
75 W
100 W
A
MM:SS
B
C
MM:SS
B
C
MM:SS
B
C
1.6 cm
2:00
2.8 cm
0.6 cm
1.9 cm
3:00
3.0 cm
0.7 cm
2:00
3.1 cm
0.8 cm
2.2 cm
4:30
3.3 cm
0.8 cm
2:30
3.3 cm
0.9 cm
2.5 cm
7:30
3.5 cm
0.9 cm
3:30
3.6 cm
0.9 cm
2:30
3.3 cm
0.7 cm
2.7 cm
10:00
3.6 cm
1.0 cm
4:30
3.8 cm
1.0 cm
3:00
3.5 cm
0.8 cm
2.9 cm
5:30
3.9 cm
1.1 cm
4:00
3.7 cm
0.8 cm
3.1 cm
7:00
4.0 cm
1.1 cm
5:00
3.9 cm
0.9 cm 
3.3 cm
9:00
4.1 cm
1.1 cm
7:00
4.0 cm
1.0 cm
3.4 cm
10:00
4.2 cm
1.1 cm
8:30
4.1 cm
1.0 cm
3.5 cm
10:00
4.2 cm
1.0 cm
Table 1
In Vivo Porcine Lung
Figure 4
B
C
A

Document No.  DLB00794-01 Rev. A 
Part No.  PLB00555-01 Rev. A
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LABEL CALLOUTS
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PRODUCT INFORMATION 
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Product Descriptor 1 Ablation Catheter Kit with  
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Product Descriptor 2 Bronchoscopic Ablation
Catalog Number
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Ablation Catheter Kit with  
Thermosphere™ Technology
PLB00678-01 Rev. A    2017-08
Emprint
TM
CA108L1
Use by
Bronchoscopic Ablation
Ablation Catheter Kit with Thermosphere™ Technology
Kit de cathéter d'ablation avec technologie Thermosphere™
Kit de cateter de ablação com tecnologia Thermosphere™
Ablationskatheter-Kit mit Thermosphere™-Technologie
Kit de catéter de ablación con tecnología Thermosphere™
Kit catetere per ablazione con tecnologia Thermosphere™
Ablatiekatheter met Thermosphere™-technologie
Ablationskatetersats med Thermosphere™-teknik
Комплект абляционного катетера по технологии Thermosphere™
摖䞷Thermosphere™㔏㦾䤓䀗娜⺋丰⯦ↅ
Sada ablačního katétru s technologií Thermosphere™
Ablationskatetersæt med Thermosphere™ teknologi
Thermosphere™韥ꯕ넩놶끞鷑놽뇑렩묁뫥멙뱭
Ablasjonskatetersett med Thermosphere™-teknologi
Zestaw cewnika do ablacji z technologią Thermosphere™
Thermosphere™ Teknolojili Ablasyon Kateter Kiti
㘰䞷Thermosphere™㔏嫢⃚䀗娜⺝丰⯦ↅ
Bronchoscopic Ablation
Ablation par bronchoscopie
Ablação transbrônquica
Bronchoskopische Ablation
Ablación broncoscópica
Ablazione per via broncoscopica
Bronchoscopische ablatie
Bronkoskopisk ablation
Абляция при бронхоскопии
㞾㺣丰柫䀗娜
Bronchoskopická ablace
Bronkoskopisk ablation
韥隵덵陲놽뇑
Bronkoskopisk ablasjon
Ablacja bronchoskopowa
Bronkoskopik Ablasyon
㞾㺲丰晰ₚ䀗娜
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Subject # __________________ 
 
Version 2.0 01Jun18 
NAVABLATE Study 
Page 1 of 2 
Bronchoscopic Ablation Patient Pain and Satisfaction Survey 
As a participant in the NAVABLATE study, you are being asked to complete this survey.  Please take a few 
minutes to complete the form.  The information you provide will be used to evaluate patients’ satisfaction with 
the Bronchoscopic Ablation procedure.  
 
 
Date Survey Completed: ___________________ 
 
What level of pain or discomfort did you experience 
because of the Bronchoscopic Ablation procedure:        
Using the scale above as a guide, please 
circle the number that best fits your 
answer: 
Immediately after the Bronchoscopic Ablation 
procedure?                                          
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
One week after the Bronchoscopic Ablation 
procedure?                                              
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
One month after the Bronchoscopic Ablation 
procedure?                                            
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
 
 
Grade 
Degree of breathlessness related to activities (MRC Breathlessness Scale)* 
1 
Not troubled by breathlessness except on strenuous exercise 
2 
Short of breath when hurrying on the level or walking up a slight hill 
3 
Walks slower than most people on the level, stops after 1.5 kilometers or so, or stops after 15 
minutes walking at own pace 
4 
Stops for breath after walking about 100 meters or after a few minutes on level ground 
5 
Too breathless to leave the house, or breathless when undressing 
What level of breathlessness did you experience because 
of the Bronchoscopic Ablation procedure:        
Using the scale above as a guide, please 
circle the number that best fits your 
answer: 
 
 
 
 
 
 
Immediately after the Bronchoscopic Ablation 
procedure?                                          
1 
2 
3 
4 
5 
One week after the Bronchoscopic Ablation 
procedure?                                              
1 
2 
3 
4 
5 
One month after the Bronchoscopic Ablation 
procedure?                                            
1 
2 
3 
4 
5 
 

Subject # __________________ 
 
Version 2.0 01Jun18 
NAVABLATE Study 
Page 2 of 2 
 
 
 
Please circle the number that best fits your answer 
Extremely 
Unlikely 
Unlikely 
Neutral 
Likely 
Extremely 
Likely 
How likely would you be willing to 
have an Bronchoscopic Ablation 
procedure performed again if 
necessary? 
1 
2 
3 
4 
5 
How likely would you recommend 
the Bronchoscopic Ablation 
procedure to family and friends if 
necessary? 
1 
2 
3 
4 
5 
 
 
Please circle the number that best fits your answer 
 
Totally 
Dissatisfied 
Dissatisfied 
Neutral 
Satisfied 
Extremely 
Satisfied 
Overall, how satisfied were you 
with the Bronchoscopic Ablation 
procedure? 
1 
2 
3 
4 
5 
 
 
Printed name of person completing this worksheet: ___________________________________ 
 
Signature: ______________________________________________ 
Date: _______________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
* Used with the permission of the Medical Research Council and adapted to include metric distance units. 
References:  1959 MRC Dyspnoea scale / MRC Breathlessness scale London, UK: Medical Research Council, Accessed: June 1, 2018. Available at: 
https://mrc.ukri.org/research/facilities-and-resources-for-researchers/mrc-scales/mrc-dyspnoea-scale-mrc-breathlessness-scale/, and  
Stenton C. The MRC breathlessness scale. Occupational medicine (Oxford, England). 2008; 58(3):226-227. 
 

 
UK (English) © 1990 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Health Questionnaire 
 
 
English version for the UK 
 
(Validated for Ireland) 
 
 
 

2 
 
UK (English) © 1990 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 
By placing a tick in one box in each group below, please indicate which statements best 
describe your own health state today. 
 
 
Mobility 
 
I have no problems in walking about 
 
I have some problems in walking about 
 
I am confined to bed 
 
 
 
Self-Care 
 
I have no problems with self-care 
 
I have some problems washing or dressing myself 
 
I am unable to wash or dress myself 
 
 
 
Usual Activities (e.g. work, study, housework, family or leisure activities) 
 
I have no problems with performing my usual activities 
 
I have some problems with performing my usual activities 
 
I am unable to perform my usual activities 
 
 
 
Pain / Discomfort 
 
I have no pain or discomfort 
 
I have moderate pain or discomfort 
 
I have extreme pain or discomfort 
 
 
 
Anxiety / Depression 
 
I am not anxious or depressed 
 
I am moderately anxious or depressed 
 
I am extremely anxious or depressed 
 
 
 

3 
 
UK (English) © 1990 EuroQol Group EQ-5D™ is a trade mark of the EuroQol Group 
9 0 
8 0 
7 0 
6 0 
5 0 
4 0 
3 0 
2 0 
1 0 
100 
0 
 
 
 
 
To help people say how good or bad a health state is, we 
have drawn a scale (rather like a thermometer) on which 
the best state you can imagine is marked 100 and the 
worst state you can imagine is marked 0. 
 
We would like you to indicate on this scale how good or 
bad your own health is today, in your opinion. Please do 
this by drawing a line from the box below to whichever 
point on the scale indicates how good or bad your health 
state is today. 
 
 
 
 
Best imaginable 
health state 
Worst imaginable 
health state 
Your own health 
state today 

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 1 of 11 
NAVABLATE Adverse Event Reference List 
Table of Contents 
 
 
Common Terminology Criteria for Adverse Events (CTCAE) .................................................................2 
Instrumental Activities of Daily Living ....................................................................................................... 2 
Self-Care Activities of Daily Living ............................................................................................................. 2 
Adverse Event and Device Deficiency Definitions ................................................................................2 
Adverse Event (AE) .................................................................................................................................... 2 
Serious Adverse Event (SAE) ..................................................................................................................... 2 
Adverse Device Effect (ADE) ..................................................................................................................... 3 
Serious Adverse Device Effect (SADE) ....................................................................................................... 3 
Unanticipated Serious Adverse Device Effect (USADE) ............................................................................ 3 
Device Deficiency ...................................................................................................................................... 3 
Adverse Event Relationship and Outcome Classifications ....................................................................4 
Adverse Event Relationship Classification ................................................................................................ 4 
Adverse Event Outcome Classification ..................................................................................................... 5 
Potential Adverse Events and Definitions ...........................................................................................6 
Atrial Fibrillation ....................................................................................................................................... 6 
Bronchopleural Fistula .............................................................................................................................. 6 
Bronchopulmonary Hemorrhage .............................................................................................................. 6 
Burn ........................................................................................................................................................... 7 
Cavitation .................................................................................................................................................. 7 
Death ......................................................................................................................................................... 7 
Hematoma ................................................................................................................................................ 7 
Hemolysis .................................................................................................................................................. 7 
Hemoptysis ............................................................................................................................................... 8 
Hemothorax .............................................................................................................................................. 8 
Lung Abscess ............................................................................................................................................. 8 
Pleural Effusion ......................................................................................................................................... 9 
Pleural Thickening ..................................................................................................................................... 9 
Pneumonia ................................................................................................................................................ 9 
Pneumothorax ........................................................................................................................................ 10 

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 2 of 11 
Post-Ablation Syndrome ......................................................................................................................... 10 
Post-Procedure Pain................................................................................................................................ 10 
Pulmonary Edema ................................................................................................................................... 11 
Pyothorax ................................................................................................................................................ 11 
Ventricular Arrhythmia ........................................................................................................................... 11 
 
 
Common Terminology Criteria for Adverse Events (CTCAE) 
A set of criteria for the standardized classification of adverse effects of drugs used in cancer therapy. 
The CTCAE system is a product of the US National Cancer Institute Cancer Therapy Evaluation 
Program. This protocol will use Version 5.0 (published 27-NOV-2017), available at 
https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50https://ctep.
cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50  
Instrumental Activities of Daily Living 
For the purpose of defining CTCAE grade, instrumental activities of daily living (ADL) refers to preparing 
meals, shopping for groceries or clothes, using the telephone, managing money, etc. 
Self-Care Activities of Daily Living 
For the purpose of defining CTCAE grade, self-care activities of daily living (ADL) refer to bathing, 
dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden.  
Adverse Event and Device Deficiency Definitions 
Adverse Event (AE) 
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.* 
*For the purposes of this clinical study, AE definitions will be ISO 14155:2011 compliant with the 
following exception:  only those adverse events that are related to the Emprint™ Ablation Catheter 
Kit with Thermosphere™ Technology, accessory devices, or study procedures will be captured and 
reported. 
NOTE 1:  This definition includes events related to the investigational medical device or the comparator. 
NOTE 2:  This definition includes events related to the procedures involved. 
NOTE 3:  For users or other persons, this definition is restricted to events related to investigational 
medical devices. 
Serious Adverse Event (SAE) 
For the purposes of this study, a Serious Adverse Event* is an adverse event that has 
1. Led to death, 

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 3 of 11 
2. Led to serious deterioration in the health of the subject, that either resulted in 
a. A life-threatening illness or injury, or 
b. A permanent impairment of a body structure or a body function, or 
c. In-patient or prolonged hospitalization, or 
d. 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 1:  This includes device deficiencies that might have led to a serious adverse event if a) suitable 
action had not been taken or b) intervention had not been made or c) if circumstances had been less 
fortunate. These are handled under the SAE reporting system.  
NOTE 2:  Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigational plan, without serious deterioration in health, is not considered a serious adverse 
event.  
*For the purposes of this clinical study, SAE definitions will be ISO 14155:2011 compliant with the 
following exception:  only those SAEs that are related to the Emprint™ Ablation Catheter Kit with 
Thermosphere™ Technology, accessory devices, or study procedures will be captured and reported. 
Adverse Device Effect (ADE) 
An Adverse Device Effect (ADE) is an adverse event related to the use of the investigational medical 
device (the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology). 
NOTE 1:  This definition includes adverse events resulting from insufficient or inadequate instructions for 
use, deployment, implantation, installation, or operation, or any malfunction of the investigational 
medical device. 
NOTE 2:  This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
Serious Adverse Device Effect (SADE) 
A Serious Adverse Device Effect (SADE) is an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
Unanticipated Serious Adverse Device Effect (USADE) 
An Unanticipated Serious Adverse Device Effect (USADE) is defined as serious adverse device effect 
which by its nature, incidence, severity or outcome has not been identified in the current version of 
the Risk Management Report. 
Device Deficiency 
Inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or 
performance. 
Note:  Device deficiencies include malfunctions, use errors, and inadequate labelling. 

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 4 of 11 
Adverse Event Relationship and Outcome Classifications 
Adverse Event Relationship Classification 
Causality assessments define the relationship between the use of the medical device (including the 
procedure) and the occurrence of each adverse event. During causality assessment activity, clinical 
judgment shall be used and the relevant documents, such as the MDR Reportable Event Trend & 
Risk Analysis Report shall be consulted, as all the foreseeable serious adverse events and the 
potential risks are listed and assessed there. The presence of confounding factors, such as 
concomitant medication/treatment, the natural history of the underlying disease, other concurrent 
illness or risk factors shall also be considered. 
Each AE and SAE will be classified according to five different levels of causality. The following definitions 
will be used to assess the relationship of the adverse event to the investigational medical device (the 
Emprint™ Ablation Catheter Kit with Thermosphere™ Technology), accessory devices, or 
procedures: 
• 
Not related:  Relationship to the device or procedures can be excluded when: 
o the event is not a known side effect of the product category the device belongs to or of similar 
devices and procedures 
o the event has no temporal relationship with the use of the investigational device or the 
procedures; 
o the serious event does not follow a known response pattern to the medical device (if the 
response pattern is previously known) and is biologically implausible; 
o the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or increase of the 
level of activation/exposure), do not impact on the serious event; 
o the event involves a body-site or an organ not expected to be affected by the device or 
procedure; 
o the serious event can be attributed to another cause (e.g. an underlying or concurrent illness/ 
clinical condition, an effect of another device, drug, treatment or other risk factors); 
o the event does not depend on a false result given by the investigational device used for 
diagnosis, when applicable; 
o harms to the subject are not clearly due to use error; 
o In order to establish the non-relatedness, not all the criteria listed above might be met at the 
same time, depending on the type of device/procedures and the serious event. 
• 
Unlikely:  The relationship with the use of the device seems not relevant and/or the event can be 
reasonably explained by another cause, but additional information may be obtained. 
• 
Possible:  The relationship with the use of the investigational device is weak but cannot be ruled out 
completely. Alternative causes are also possible (e.g. an underlying or concurrent illness/ clinical 
condition or/and an effect of another device, drug or treatment). Cases were relatedness cannot be 
assessed or no information has been obtained should also be classified as possible. 
• 
Probable:  The relationship with the use of the investigational device seems relevant and/or the 
event cannot reasonably be explained by another cause, but additional information may be 

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 5 of 11 
obtained. 
• 
Causal relationship:  The serious event is associated with the investigational device or with 
procedures beyond reasonable doubt when: 
o the event is a known side effect of the product category the device belongs to or of similar 
devices and procedures; 
o the event has a temporal relationship with investigational device use/application or procedures; 
o the event involves a body-site or organ that 
o the investigational device or procedures are applied to; 
o the investigational device or procedures have an effect on; 
o the serious event follows a known response pattern to the medical device (if the response 
pattern is previously known); 
o the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
o other possible causes (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment) have been adequately ruled out; 
o harm to the subject is due to error in use; 
o the event depends on a false result given by the investigational device used for diagnosis, when 
applicable; 
• 
In order to establish the relatedness, not all the criteria listed above might be met at the same time, 
depending on the type of device/procedures and the serious event. 
Events will be distinguished between the serious adverse events related to the device and those related 
to the procedures (any procedure specific to the clinical investigation). An adverse event can be 
related both to procedures and the device. Complications of procedures are considered not related 
if the said procedures would have been applied to the patients also in the absence of device 
use/application. 
In some particular cases the event may be not adequately assessed because information is insufficient 
or contradictory and/or the data cannot be verified or supplemented. The sponsor’s Medical 
Monitor and the Investigators will make the maximum effort to define and categorize the event and 
avoid these situations. Where the Medical Monitor remains uncertain about classifying the serious 
event, it should not exclude the relatedness and classify the event as “possible”. 
Adverse Event Outcome Classification 
Outcome of the event will be defined according to the following:  
• 
Fatal:  If death was possibly, probably, or causally related to the event 
• 
Not recovered / not resolved:  Subject has exited the study and the AE is ongoing and not 
expected to resolve 
• 
Recovered / resolved:  The event has fully resolved prior to study exit 
• 
Recovered / resolved with sequelae:  The event has resolved prior to study exit, but retained 
pathological conditions resulting from the prior disease or injury  

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 6 of 11 
• 
Recovering / resolving:  The subject has exited the study and the AE is ongoing but expected to 
resolve 
• 
Unknown:  The subject has exited the study and the AE outcome is unknown 
Potential Adverse Events and Definitions 
Atrial Fibrillation 
A disorder characterized by a dysrhythmia without discernible P waves and an irregular ventricular 
response due to multiple reentry circuits. The rhythm disturbance originates above the ventricles. 
Degree of severity will be classified according to Common Terminology Criteria for Adverse Events 
(CTCAE) grade as follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Asymptomatic, intervention not indicated 
• 
Grade 2:  Non-urgent medical intervention indicated 
• 
Grade 3:  Symptomatic, urgent intervention indicated; device (e.g., pacemaker); ablation; new onset 
• 
Grade 4:  Life-threatening consequences; embolus requiring urgent intervention 
• 
Grade 5:  Death 
Bronchopleural Fistula 
A disorder characterized by an abnormal communication between a bronchus and the pleural cavity. 
Degree of severity will be classified according to Common Terminology Criteria for Adverse Events 
(CTCAE) grade as follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Asymptomatic 
• 
Grade 2:  Symptomatic, invasive intervention not indicated 
• 
Grade 3:  Hospitalization; invasive intervention indicated 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated 
• 
Grade 5:  Death 
Bronchopulmonary Hemorrhage 
A disorder characterized by bleeding from the bronchial wall and/or lung parenchyma. Degree of 
severity will be classified according to CTCAE grade as follows (a semicolon indicates “or” within the 
description of the grade): 
• 
Grade 1:  Mild symptoms; intervention not indicated 
• 
Grade 2:  Moderate symptoms; medical intervention indicated 
• 
Grade 3:  Transfusion, invasive intervention indicated (e.g., hemostasis of bleeding site) 
• 
Grade 4:  Life-threatening respiratory or hemodynamic compromise; intubation or urgent 
intervention indicated 
• 
Grade 5:  Death 

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 7 of 11 
Burn 
Unintended microwave burn – unintended tissue ablation 
Unintended microwave burn – vessel thrombosis /thrombus /embolism 
Unintended microwave burn – diaphragmatic paresis 
A finding of impaired integrity to the anatomic site of an adverse thermal reaction. Burns can be caused 
by exposure to chemicals, direct heat, electricity, flames and radiation. The extent of damage 
depends on the length and intensity of exposure and time until provision of treatment. Degree of 
severity will be classified according to CTCAE grade as follows (a semicolon indicates “or” within the 
description of the grade): 
• 
Grade 1:  Minimal symptoms; intervention not indicated 
• 
Grade 2:  Medical intervention; minimal debridement indicated 
• 
Grade 3:  Moderate to major debridement or reconstruction indicated 
• 
Grade 4:  Life-threatening consequences; hemodynamic compromise 
• 
Grade 5:  Death 
Cavitation 
Seen on follow-up imaging 
Death 
End of life 
Hematoma 
A disorder characterized by a localized collection of blood, usually clotted, in an organ, space, or tissue, 
due to a break in the wall of a blood vessel. Degree of severity will be classified according to CTCAE 
grade as follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Mild symptoms; intervention not indicated 
• 
Grade 2:  Minimally invasive evacuation or aspiration indicated 
• 
Grade 3:  Transfusion; invasive intervention indicated 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated 
• 
Grade 5:  Death 
Hemolysis 
A disorder characterized by laboratory test results that indicate widespread erythrocyte cell membrane 
destruction. Degree of severity will be classified according to CTCAE grade as follows (a semicolon 
indicates “or” within the description of the grade): 
• 
Grade 1:  Laboratory evidence of hemolysis only (e.g., direct antiglobulin test; DAT; Coombs’; 
schistocytes; decreased haptoglobin)  
• 
Grade 2:  Evidence of hemolysis and >=2 g decrease in hemoglobin 
• 
Grade 3:  Transfusion or medical intervention indicated (e.g., steroids) 

NAVABLATE Adverse Event Reference List 
 
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Version: 2.0, 24/Sep/2019 
 Page 8 of 11 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated 
• 
Grade 5:  Death 
Hemoptysis 
Coughing up of blood or blood-stained mucous from the lung. Degree of severity will be classified 
according to CTCAE general guidelines as follows (a semicolon indicates “or” within the description 
of the grade): 
• 
Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• 
Grade 2:  Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. 
• 
Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL. 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated. 
• 
Grade 5: Death related to AE. 
Hemothorax 
A hemothorax is a type of pleural effusion in which blood accumulates in the pleural cavity. Degree of 
severity will be classified according to CTCAE general guidelines as follows (a semicolon indicates 
“or” within the description of the grade): 
• 
Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• 
Grade 2:  Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. 
• 
Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL. 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated. 
• 
Grade 5:  Death related to AE. 
Lung Abscess  
Lung abscess is a pus-filled cavity in the lung surrounded by inflamed tissue and caused by an infection. 
Degree of severity will be classified according to CTCAE general guidelines as follows (a semicolon 
indicates “or” within the description of the grade): 
• 
Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• 
Grade 2:  Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. 
• 
Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL. 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated. 

NAVABLATE Adverse Event Reference List 
 
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Version: 2.0, 24/Sep/2019 
 Page 9 of 11 
• 
Grade 5:  Death related to AE. 
Pleural Effusion 
A disorder characterized by an increase in amounts of fluid within the pleural cavity. Symptoms include 
shortness of breath, cough and marked chest discomfort. Degree of severity will be classified 
according to CTCAE grade as follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Asymptomatic; clinical or diagnostic observations only; intervention not indicated 
• 
Grade 2:  Symptomatic; intervention indicated (e.g., diuretics or therapeutic thoracentesis) 
• 
Grade 3:  Symptomatic with respiratory distress and hypoxia; operative intervention including chest 
tube or pleurodesis indicated 
• 
Grade 4:  Life-threatening respiratory or hemodynamic compromise; intubation or urgent 
intervention indicated 
• 
Grade 5:  Death 
Pleural Thickening 
Pleural thickening is a descriptive term given to describe any form of thickening involving either the 
parietal or visceral pleura. Degree of severity will be classified according to CTCAE general guidelines 
as follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• 
Grade 2:  Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. 
• 
Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL. 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated. 
• 
Grade 5:  Death related to AE. 
Pneumonia  
A bacterial, viral, or fungal infection causing inflammation of the lungs. Degree of severity will be 
classified according to CTCAE grades for Lung Infection as follows (a semicolon indicates “or” within 
the description of the grade): 
• 
Grade 1:  Not applicable 
• 
Grade 2:  Moderate symptoms; oral intervention indicated (e.g., antibiotic, antifungal, or antiviral) 
• 
Grade 3:  IV antibiotic, antifungal, or antiviral intervention indicated; invasive intervention indicated 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated 
• 
Grade 5:  Death 

NAVABLATE Adverse Event Reference List 
 
Medtronic Confidential 
Version: 2.0, 24/Sep/2019 
 Page 10 of 11 
Pneumothorax 
A disorder characterized by abnormal presence of air in the pleural cavity resulting in the collapse of the 
lung. Degree of severity will be classified according to CTCAE grade as follows (a semicolon indicates 
“or” within the description of the grade): 
• 
Grade 1:  Asymptomatic; clinical or diagnostic observations only; intervention not indicated 
• 
Grade 2:  Symptomatic; intervention indicated (e.g., tube placement without sclerosis) 
• 
Grade 3:  Sclerosis and/or operative intervention indicated; hospitalization indicated 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated 
• 
Grade 5:  Death 
Post-Ablation Syndrome 
A transient, self-limiting symptom/sign complex of low-grade fever, nausea, vomiting, and general 
malaise. Most patients who experience this syndrome will experience some malaise for 2-7 days, 
depending on the tumor volume, volume of ablation zone necrosis, and the integrity of the patient’s 
immune system. Degree of severity will be classified according to CTCAE general guidelines as 
follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• 
Grade 2:  Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. 
• 
Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL. 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated. 
• 
Grade 5:  Death related to AE. 
Post-Procedure Pain 
Post-procedure pain will be evaluated both by a Bronchoscopic Ablation Patient Pain and Satisfaction 
Survey (see Appendix 17.4 of the CIP) and according to the CTCAE general guidelines as follows (a 
semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• 
Grade 2:  Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. 
• 
Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL. 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated. 
• 
Grade 5:  Death related to AE. 

NAVABLATE Adverse Event Reference List 
 
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Version: 2.0, 24/Sep/2019 
 Page 11 of 11 
Pulmonary Edema 
A disorder characterized by accumulation of fluid in the lung tissues that causes a disturbance of the gas 
exchange that may lead to respiratory failure. Degree of severity will be classified according to 
CTCAE grade as follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Radiologic findings only; minimal dyspnea on exertion 
• 
Grade 2:  Moderate dyspnea on exertion; medical intervention indicated; limiting instrumental ADL 
• 
Grade 3:  Severe dyspnea or dyspnea at rest; oxygen indicated; limiting self-care ADL 
• 
Grade 4:  Life-threatening respiratory compromise; urgent intervention or intubation with 
ventilatory support indicated 
• 
Grade 5:  Death 
Pyothorax 
An infection in the chest cavity. Degree of severity will be classified according to CTCAE general 
guidelines as follows (a semicolon indicates “or” within the description of the grade): 
• 
Grade 1:  Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated. 
• 
Grade 2:  Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate 
instrumental ADL. 
• 
Grade 3:  Severe or medically significant but not immediately life-threatening; hospitalization or 
prolongation of hospitalization indicated; disabling; limiting self-care ADL. 
• 
Grade 4:  Life-threatening consequences; urgent intervention indicated. 
• 
Grade 5:  Death related to AE. 
Ventricular Arrhythmia 
A disorder characterized by a dysrhythmia that originates in the ventricles. Degree of severity will be 
classified according to CTCAE grade as follows (a semicolon indicates “or” within the description of 
the grade): 
• 
Grade 1:  Asymptomatic, intervention not indicated 
• 
Grade 2:  Non-urgent medical intervention indicated 
• 
Grade 3:  Urgent intervention indicated 
• 
Grade 4:  Life-threatening consequences; hemodynamic compromise 
• 
Grade 5:  Death 
 

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This document is electronically controlled 
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Informed Consent Template 
Clinical Investigation Plan Title  Clinical description of a bronchoscopic approach to 
ablate lung nodules using the Emprint™ Ablation 
Catheter Kit with Thermosphere™ Technology 
Clinical Investigation Plan Identifier MDT18010ILSBA 
Sponsor/Local Sponsor Medtronic 
Minimally Invasive Therapies Group (MITG) 
Surgical Innovations (SI), Lung Health 
161 Cheshire Lane, Suite 100 
Plymouth, MN 55441 
Principal Investigator: Full PI Name (Leave as a placeholder if master 
study-specific Informed Consent); if not applicable, 
delete row 
Clinica l Site: Institution name, address and contact information 
(Leave as a placeholder if master study-specific 
Informed Consent); if not applicable, mark as ‘N/A’ 
or delete row 
Study Related Telephone: Include telephone numbers to be utilized during 
regular office hours as well as outside regular office 
hours 
Informed Consent Document Version Master Consent Template; Version 2; 06Sep19 
Confidentiality Statement 
The information contained in this document is confidential and the proprietary property of Medtronic. Any 
distribution, copying, or disclosure without the prior written authorization of Medtronic is strictly 
prohibited. Persons to whom the information is disclosed must know that it is confidential and that it may 
not be further disclosed by them. 
 
 
 

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INTRODUCTION 
In this consent form, “you” always means the study participant.  
 
Why am I being asked to be in this study? 
You are being asked to be in a study that involves clinical research. Being in this study is voluntary. Before you 
decide if you would like to be in the study, it is important you understand why the study is being conducted and 
what it will involve. Please read this form carefully and ask your doctor if you have any questions. Upon reading 
this form and asking any questions you have, you will sign and date the last page of this form if you decide to 
be in this study.  
 
The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is the device that will be used in your 
lung ablation procedure. Although this device is approved by regulatory authorities and is commercially 
available, this procedure is not routinely used in normal clinical care of lung nodules. Only qualified physicians 
with appropriate training are currently allowed to use it and perform this procedure. If you agree to 
participating in this study, information will be collected relating to your condition and medical care, including 
information about your lung ablation procedure. 
 
Study Purpose: 
The purpose of this study is to look at the safety and performance of the bronchoscopic ablation 
procedure using the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology. Detailed medical 
information will be collected on you and your ablation procedure. You will also be asked to answer 
questions that are not typically obtained during normal clinical care. 
 
System description: 
The device being studied is a microwave ablation system called the “Emprint™ Ablation Catheter Kit 
with Thermosphere™ Technology”. This device uses microwave energy to generate heat that can 
destroy your lung nodule. The device has thermal-control features to heat up your lung nodule and a 
small area around your nodule, while avoiding most of your healthy lung tissue. Imaging systems will be 
used by your doctor to guide the ablation catheter to your lung nodule. You will be given anesthesia for 
the procedure.  
 
How long will I be in the study? How many people will be in the study? 
About 30 will be in this study worldwide. Your participation in the study may last about 1-2 months.  
The overall study is expected to last a total of 18 months. 
 
What are my responsibilities during the study?  
Being in this study, it is important that you: 
• 
Tell the study doctor about your medical and medication history 
• 
Attend all visits scheduled with the study doctor 
• 
Call the study doctor’s office to reschedule a missed visit as soon as possible 
• 
Report any injuries, hospitalizations, emergency room visits, symptoms or complaints to the 
study doctor or nurse as soon as possible. 
 
What will happen if I am in this study?  
Study Procedures: 
If you decide to be in this study, the study doctor and study nurse will collect information about you and your 
medical history. This includes any medication you currently take and any other information in your medical 
records related to your condition or treatment that may be relevant to your being in the study. 

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For this study, your study doctor will schedule 2-3 visits with you. You must make sure that you can come to 
each visit as scheduled. 
 
Baseline Visit 
At this visit the following procedures will be carried out: 
• 
Review of eligibility to participate in this study 
At this visit the following information will be collected: 
• 
Demographic information (year of birth, gender, etc) 
• 
Medical History such as specific diagnoses, previous lung procedures, smoking history, etc. 
• 
General health information 
• 
Information on your cancerous lung nodule (Review of your computed tomography scan (also called 
a CT or “CAT” scan) 
• 
Quality of life survey called the EQ-5D (not typically collected during routine clinical care) 
 
Procedure Visit 
At this visit the following procedures will be carried out: 
• 
Confirmation of eligibility to participate in this study (This is when you will be enrolled in the study) 
• 
The Bronchoscopic Ablation Procedure (This procedure uses a type of X-ray, called fluoroscopy, and 
Cone Beam Computed Tomography (CBCT) scans, to help guide the doctor during the procedure) 
• 
Images of your lung will be obtained prior to, during, and after the procedure 
• 
Evaluation of your general health 
At this visit the following information will be collected: 
• 
Procedure and lung nodule information 
• 
Current medications 
• 
General health information 
 
1-month / Exit Visit 
At this visit the following procedures will be carried out: 
• 
Evaluation of your general health 
• 
Follow-up computed tomography scan (also called a CT or “CAT” scan) 
At this visit the following information will be collected: 
• 
Current medications 
• 
General health information 
• 
Quality of life survey called the EQ-5D (not typically collected during routine clinical care) 
• 
Bronchoscopic Ablation Patient Pain and Satisfaction Survey (not typically collected during routine 
clinical care) 
 
What are the possible risks, side-effects and inconveniences? 
The risks of undergoing an ablation procedure are the same whether you choose to take part in the study 
or not. It is important to understand that you do not need to take part in the study to receive the ablation 
procedure. Since the Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is commercially 
available, your doctor will discuss the potential benefits, risks and any alternative options. 
 
Should you wish to take part, you will receive separate consent forms: 
• 
one for the study 
• 
one for the bronchoscopic ablation procedure as part of your standard care 
 

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Potential discomforts or complications associated with ablation procedures are listed below. Previous study 
assessments have shown these complications occur in less than 1% of patients. If you would like more 
information on these risks, please ask your doctor. 
• 
Post-ablation syndrome (a transient, self-limiting symptom/sign complex of low-grade fever, nausea, 
vomiting, and general malaise) 
• 
Post-procedure pain (pain because of the procedure) 
• 
Pneumothorax (abnormal presence of air in the chest cavity causing collapse of the lung) 
• 
Hemothorax (bleeding into the chest cavity) 
• 
Pleural effusion (fluid build-up in the cavity) 
• 
Pleural thickening (any form of thickening involving either the parietal or visceral pleura) 
• 
Pulmonary edema (fluid buildup in the lungs themselves which causes difficulty breathing) 
• 
Pneumonia (chest infection) 
• 
Empyema (infection or pus in the chest cavity) 
• 
Lung abscess formation (abscess or collection of pus in the lung) 
• 
Hematoma (a blood clot or bruise) 
• 
Hemoptysis (coughing up of blood or blood-stained mucus) 
• 
Bronchopulmonary hemorrhage (bleeding from the bronchi (windpipes) or lungs) 
• 
Bronchopleural fistula (an abnormal communication between a bronchus and the chest cavity) 
• 
Death (end of life) 
• 
Atrial fibrillation (a dysrhythmia without discernible P waves and an irregular ventricle response to 
multiple reentry circuits. The rhythm disturbance originates above the ventricles.) 
• 
Ventricular arrhythmia (abnormal heart rate or rhythm) 
• 
Stroke (a decrease or absence of blood supply to the brain resulting in damage to the brain and its 
functions) 
• 
Damage to other body structures (nerves or vessel damage) 
• 
Hemolysis (laboratory test result that indicate red blood cell destruction) 
• 
Unintended microwave burn (burn in an area that was not meant to be heated) 
 
You may not take part in this study if you are breastfeeding or pregnant. If you are or you become pregnant, 
there may be risks to you or your unborn child that are not yet known. 
 
There is a possible risk of breach of confidentiality. This risk is minimized by protections described in this 
document. All records identifying you will be kept confidential and, to the extent permitted by the applicable 
laws and/or regulations, will not be made publicly available. 
 
Radiation risks:  
The CT scan and the imaging that will be carried out as part of your ablation procedure are part of your 
routine care. If you take part in this study, you will not undergo any additional imaging procedures. These 
procedures use ionizing radiation to form images of your body and provide your doctor with other clinical 
information. Ionizing radiation can cause cell damage that may, after many years or decades, turn 
cancerous. The chances of this happening to you are the same whether you take part in this study or not. 
 
What are the possible benefits of the study?  
If you agree to be in this study, it is possible that you may not have any direct medical benefits. Possible 
benefits in addition to a commercially available product include the following:  
• 
The information from this study may benefit other subjects with lung nodules in the future. 
• 
If the results of this study are favorable, further studies may be justified to evaluate the potential 
for improved standard of care using microwave ablation technology in lung nodules for future 
patients. 

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• 
The information gathered in this study may help doctors to understand how to improve the 
management of cancer in the lung. It may lead to improvements in care or to the development of 
new devices/systems/interventions which may benefit yourself or other patients in the future. 
 
What happens when I end being in the study?  
Once you have completed the study, your doctor will continue to monitor you as per standard of care. 
 
What other treatment choices do I have if I am not in the study? 
You do not have to be in this study to be treated for cancer in your lung. 
If you decide not to be in this study, your doctor will discuss with you all the options for medical care, 
including performing the ablation procedure outside of this study. You may choose no treatment at all. 
You should discuss other treatments and their possible risks and benefits with your doctor. 
 
Who is paying for this study?  
The study site will receive payment from Medtronic for work involved in collecting study data and managing 
the study at the site. The sponsor will also pay for any additional test or procedures which are not part of 
your routine care. 
  
Will I be paid for being in this study? 
You will not be paid for being in this study. 
 
What will I have to pay for if I am in this study? 
Any tests or procedures carried out for study purposes will be provided at no cost to you. Your routine care 
will be provided by the hospital under standard procedures. 
 
What happens if I am injured or hurt during this study? 
Medtronic maintains appropriate clinical trial liability insurance coverage as required under applicable laws 
and regulations and will comply with applicable local law and custom concerning specific insurance 
coverage. If required, a Clinical Trial insurance statement/certificate will be provided to your Medical 
Institution’s Ethics Committee. 
By agreeing to this, you do not give up any of your legal rights. You do not release the study sponsor, 
study doctors, or the hospital from responsibility for negligence. 
 
Do I have the right to refuse to be in this study or to leave this study? 
Being in this study is voluntary. You may choose not to be in the study or to leave the study at any time 
for any reason. If you choose not to be in the study, leave the study, or the study is discontinued, this 
will not result in any penalty and you will not lose any benefits to which you are entitled. Your regular 
care and your relationship with the hospital or clinic and your doctors will not be affected.  
 
You will be told about any new information that may make you change your mind about staying in the 
study. You may be asked to sign a new consent form if this occurs. 
 
You may leave the study simply by telling the study doctor. If you choose to leave the study, or the study 
is discontinued, there are no specific tests that are required prior to leaving the study.  
 
The study doctors may take you out of the study without your permission if: 
• 
It is in your best medical interest 
 
You are for any reason unable to follow your study doctor’s instructions.  
• 
The study sponsor stops the study if: 

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o 
It is in the best interest of your health and the health of other study subjects or  
o 
Your study doctor is no longer available to oversee the study and no suitable replacement is 
found.  
If this happens you will be notified about being removed from the study and you will be provided with an 
explanation about such decision. 
 
Use for countries outside Europe: 
All of your health data already collected for the study cannot be removed from the study data and will 
continue to be used as described in this form even after your participation in the study has ended. 
Use for countries in Europe: 
All of your health data already collected for the study can still be used by the study sponsor unless you 
object and ask for deletion of the data. 
 
It is also important to understand that there is a chance your procedure may start, but the ablation portion 
may not occur if any new information is obtained during the procedure that disqualifies you from having 
an ablation procedure (for example a risk to your safety is identified). Signing this consent does not 
automatically enroll you into the study. If you do sign this consent and don’t undergo the ablation 
procedure, the reason you could not be enrolled will be recorded. 
 
What is the role of the sponsor’s representative? 
Trained Medtronic personnel may be present at the bronchoscopic procedure and at study follow-up visits. 
The role of the Medtronic person is to give technical support.  Authorized sponsor representatives will also 
check data for accuracy and regulatory purposes. 
 
How will the sponsor use the study information? 
If you decide to participate in the study, Medtronic (including, for purposes of this section, its agents and 
contractors) and others who work with the study will see health information about you. This consent form 
governs how your health information is disclosed and used. 
 
This consent form describes the study, and what Medtronic will do with the study data, including your 
health information received during the study. Medtronic will keep your health information confidential in 
accordance with all applicable laws and regulations. Medtronic may use your health information to conduct 
this research, as well as for additional purposes, such as overseeing and improving the performance of its 
device, new medical research and proposals for developing new medical products or procedures. Any 
reports or publications about the study or any other research will not include your name or a description 
of you. Information received during the study will not be used to market to you; your name will not be 
placed on any mailing lists or sold to anyone for marketing purposes. Regulations and applicable laws, 
control Medtronic’s work in developing and assuring the safety and quality performance of its medical 
devices. Medtronic may disclose your health information to U.S. and foreign government authorities 
responsible for assuring the safety of medical devices. Medtronic also may disclose your health information 
to Ethics Committees and other persons who are required to watch over the safety and effectiveness of 
medical products and therapies and the conduct of research. You agree to allow Medtronic to use study 
data in these ways. You also agree to allow governmental authorities to inspect your health information. 
 
To participate in the study, you will need to sign this consent form. 
 
Where can I find out about the study results? 
A description of this study will be available on http://www.ClinicalTrials.gov.  This website will not 
include information that can identify you. At most, the website (databases) will include a summary of the 

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This document is electronically controlled 
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results. You can consult the general outcome and results of this study after they have been made publicly 
available by consulting this website. 
 
Who can I call with questions, complaints or if I’m concerned about my rights as a 
participant? 
If you have any questions about the research or being in this study, you should contact insert name at 
insert telephone number. 
If you think you have a research-related injury, you should contact insert name at insert telephone 
number. 
If you have any questions about your rights as a participant you should contact insert name at insert 
telephone number. 
 
Who has reviewed the study? 
This study was reviewed and approved by the insert name of committee Research Ethics Committee. 
 
 

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INFORMED CONSENT FOR THE MEDTRONIC 
NAVABLATE CLINICAL STUDY 
SUBJECT INFORMED CONSENT FORM SIGNATURE SHEET 
• 
I have read the subject information for this study and my study doctor has answered all my questions 
regarding the study. 
• 
I had sufficient time to consider my participation in this study, I am aware that participation in this 
study is completely voluntary, and I agree to follow the instructions from the study doctor. 
• 
I realize that I may decide to refuse participation or stop participation at any time without penalty 
and without affecting the quality of my health care or the relationship with my study doctor. 
• 
I understand and agree that personal information about me will be collected from my medical 
records, used and processed (manually and by computer) by the manufacturer of a product used in 
my treatment or any other designated party that is involved in the study (e.g., hospital, study doctor, 
regulatory authorities, ethics committees). 
• 
I understand and agree that representatives from Medtronic, regulatory authorities and the Ethics 
Committee will be granted direct access to my medical records. 
• 
I understand and agree that the study doctor(s)/hospital will release the relevant personal 
information about me for the purpose of the study. 
• 
I understand that I am entitled to access the personal information collected about me and to have 
inaccuracies corrected. 
• 
I agree to voluntarily be in and comply with this study. 
• 
I understand that I will receive a dated and signed copy of the subject informed consent form. 
 
 
 
 
 

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This document is electronically controlled 
Medt ronic Cont rolled Informat ion 056-F279, v B Informed Consent Template 
It is your choice if you would like your personal physician to be informed of your participation in this 
study. Please check one of the boxes below to show your choice: 
 
 
! must be checked by subject 
 
 I agree to inform my personal doctor about my participation in this study 
 
 I do not agree to inform my personal physician about my participation in the study 
 
Signature of the subject 
 
 
I agree to be in this study and I have consented before the initiation of any study 
specific procedures. 
 
 
 
 
 
 
Subject: 
 
 
 
 
 
 
 
 
 
Name 
Signature 
Date (DD/MMM/YYYY) 
 
Must be written by subject! 
Must be written by 
subject! 
 
 
 
 
 
 
 
Study doctor or designated person by study doctor: 
I have conducted the informed consent discussion. 
 
 
 
 
 
 
 
 
 
Name 
Signature 
Date (DD/MMM/YYYY) 
 
Must be written by study 
doctor or delegate! 
Must be written by study 
doctor or delegate! 
 
 
 
 
 
 
DOCUMENT CHANGE HISTORY 
 
Revision 
Description of Change 
Author 
1.0 
08-May-2018 First issue 
Jennifer Wolvers 
2.0 
06-Sep-2019. Updated to be MDR compliant.  Updates to 
this sample ICF were also made based on 
comments/suggestions from country specific sites. 
Jennifer Wolvers