The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Phase: NA
Conditions: Lung Cancer
Sponsor: Medtronic - MITG

CONFIDENTIAL 
Protocol COVEMPR0437, Version 3.0 
05 March 2018 
 
1 
 
 
 
 
 
Clinical Investigational Plan (CIP) Information 
Protocol Title 
The EMPrint™ Ablate and RESect Study in Patients with 
Metastatic Lung Tumors (EMPRESS) 
CIP Number 
COVEMPR0437 
Version Date 
05 March 2018 
Revision 
Version 3.0 
 
Sponsor 
Representative 
Amanda Cafaro RN, BSN 
Director Clinical 
Research 
 
Summary of Changes to CIP 
Rev. 
Section 
Description of Change 
Reason for Change 
2.0 
3.2.2 Procedure Planning 
Application 
Change from investigational device to 
FDA cleared device with specific 
indications for use 
FDA cleared the procedure planning application 
5.3.1 Histological 
Analysis 
Change number and type of samples read 
at core lab; change from 2 to 3 categories 
to evaluate complete ablation: 1) 
Complete Ablation, 2) Delayed Necrosis, 
3) Incomplete Ablation 
Consistent with final Histology Charter; add 
subgroup for delayed necrosis 
5.5.1 Inclusion Criteria 
Add inclusion of primary LC; reduce 
tumor-free parenchyma requirement 
between the pleura and tumor from ≥ 2cm 
to ≥ 1cm 
Investigator feedback 
5.5.2 Pre-procedure 
Exclusion Criteria 
Exclude only GOLD Stage IV instead of 
GOLD Stage III and IV; delete specific 
test parameters for uncontrollable 
Inclusion of primary LC population more likely to 
have GOLD Stage III disease and be surgical 

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coagulopathy 
candidates; investigator feedback 
5.7.5 Microwave 
Ablation Planning and 
Procedure 
Addition of 4th CT after antenna 
is removed 
Capture acute pneumothorax and/or bleeding 
events attributed to ablation procedure 
5.7.6 Planned Surgical 
Resection 
Change acceptable time delay until 
surgical procedure definition from “day 
after ablation” to 36 hours after 
ablation. Change definition of protocol 
deviation to surgery performed beyond 
36 hours after ablation, 
Clarify definition for protocol deviation 
5.7.8 Sample Preparation 
for Histological Analysis 
Addition of dye and fixation methods 
Consistent with final Histology Charter 
7.2 Risks associated with 
Additional Radiation 
Exposure from Study- 
related CT imaging 
Updated dose of radiation exposure 
Addition of 4th CT 
8.10 Adverse Event 
Recording and Reporting 
Specify which adverse events will 
be collected 
Consistent with final Safety Plan 
11.1 Statement of 
Compliance 
Statement following ISO GCP 
clarity 
13.0 Monitoring 
Statement following ISO GCP 
clarity 
 
3.0 
CIP Information 
Removed Sponsor Representative 
Location  
Redaction of personal and proprietary information for 
CT.gov Results Posting to comply with Final Rule 
3.1 Background/Justification 
of Investigation 
Removed internal background 
information 
Redaction of personal and proprietary information for 
CT.gov Results Posting to comply with Final Rule 
 
3.2 Report of Prior 
Investigations  
Removed internal and proprietary 
information; Removed Infernally 
referenced documents  
Redaction of personal and proprietary information for 
CT.gov Results Posting to comply with Final Rule 

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Principal Investigator Signature Page 
 
 
 
 
Protocol Title: 
The EMPrint™ Ablate and RESect Study in Patients with 
Metastatic Lung Tumors (EMPRESS) 
Protocol Number: 
COVEMPR0437 
Revision: 
3.0 
 
 
I, the undersigned, have read and understood the protocol specified above and agree on its 
content. I agree to perform and conduct the study as described in the protocol and in accordance 
with the relevant laws/regulations and standards outlined in the Clinical Trial Agreement. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Name 
Signature 
Date 

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1.0 Table of Contents 
1.0 
Table of Contents ................................................................................................................ 4 
2.0 
Acronyms and Definitions .................................................................................................. 7 
3.0 
Introduction ......................................................................................................................... 8 
3.1 
Background/Justification of Investigation ........................................................................ 8 
3.2 
Report of Prior Investigations........................................................................................... 9 
4.0 
Identification and Description of Devices ......................................................................... 18 
4.1 
Device Description ......................................................................................................... 18 
4.2 
Indications ...................................................................................................................... 18 
4.3 
Warnings ........................................................................................................................ 18 
4.4 
Identification and Dosage ............................................................................................... 18 
5.0 
Study Design ..................................................................................................................... 19 
5.1 
Overview ........................................................................................................................ 19 
5.2 
Primary Effectiveness Endpoint: Dose Response ........................................................... 19 
5.2.1 
Predicted Ablation Zone Size .................................................................................. 19 
5.2.2 
Predicted Ablation Zone Shape ............................................................................... 20 
5.2.3 
Actual Ablation Zone Size ...................................................................................... 20 
5.2.4 
Actual Ablation Zone Shape ................................................................................... 20 
5.2.5 
Confirmation of Dose Response: Ablation Zone Size ............................................ 20 
5.3 
Secondary Endpoint ....................................................................................................... 21 
5.3.1 
Histological Analysis .............................................................................................. 21 
5.4 
Selection of Investigators and Training .......................................................................... 21 
5.5 
Subject Selection and Enrollment .................................................................................. 22 
5.5.1 
Inclusion Criteria ..................................................................................................... 22 
5.5.2 
Pre-procedure Exclusion Criteria ............................................................................ 23 
5.5.3 
Intraprocedural Exclusion Criteria .......................................................................... 23 
5.6 
Withdrawal of Subjects .................................................................................................. 23 
5.7 
Study Procedures ............................................................................................................ 23 
5.7.1 
Study Assessments Table ........................................................................................ 23 
5.7.2 
Informed Consent and Screening ............................................................................ 25 
5.7.3 
Screening / Baseline Visit ....................................................................................... 25 
5.7.4 
Screen Failures ........................................................................................................ 26 
5.7.5 
Microwave Ablation ................................................................................................ 26 
5.7.6 
Planned Surgical Resection ..................................................................................... 29 

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5.7.7 
Postoperative Evaluation / End of Study Visit ........................................................ 30 
5.7.8 
Sample Preparation for Histological Analyses ........................................................ 30 
6.1 
Statistical Analysis ............................................................................................................ 30 
6.2 
General ........................................................................................................................... 30 
6.3 
Sample Size Determination ............................................................................................ 30 
6.4 
Analysis Populations ...................................................................................................... 30 
6.5 
Demographics and Other Subject Characteristics........................................................... 31 
6.6 
Effectiveness Analysis .................................................................................................... 31 
6.6.1 
Primary Endpoint .................................................................................................... 31 
6.6.2 
Secondary Endpoints .............................................................................................. 31 
6.7 
Safety Analysis ............................................................................................................... 31 
6.7.1 
Exposure .................................................................................................................. 31 
6.7.2 
Adverse Events & Complications ........................................................................... 32 
6.8 
Interim Analyses ............................................................................................................. 32 
6.9 
Handling of Missing Data .............................................................................................. 32 
7.1 
Risk/Benefit Analysis ........................................................................................................ 32 
7.2 
Anticipated Risks Associated with Lung Tumor Ablation Reported in Literature and by 
Investigators .............................................................................................................................. 33 
7.3 
Risks Associated with Additional Radiation Exposure for Study-Related CT Imaging 34 
7.3 
Risks Associated with Study Procedure ......................................................................... 34 
7.4 
Potential Benefits to the Subject..................................................................................... 34 
8.1 
Adverse Events, Complications, and Product Complaints ................................................ 35 
8.2 
Adverse Event (AE) ....................................................................................................... 35 
8.3 
Serious Adverse Event (SAE) ........................................................................................ 35 
8.4 
Adverse Device Effect (ADE) ........................................................................................ 35 
8.5 
Serious Adverse Device Effect (SADE) ......................................................................... 36 
8.6 
Unanticipated Serious Adverse Device Effect (USADE) .............................................. 36 
8.7 
Definitions of Specific Adverse Events .......................................................................... 36 
8.8 
Adverse Event Severity Classification ........................................................................... 38 
8.9 
Adverse Event Relationship Classification..................................................................... 38 
8.10 Adverse Event Outcome Classification .......................................................................... 39 
8.11 
Adverse Event Recording and Reporting.................................................................... 39 

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8.12 
Notification to Authorities .......................................................................................... 40 
9.0 
Device Deficiencies........................................................................................................... 40 
10.1 
Safety Committees ............................................................................................................ 40 
10.2 
Independent Medical Monitor..................................................................................... 41 
11.0 
Steering Committee ........................................................................................................... 41 
12.1 
Compliance ....................................................................................................................... 41 
12.2 Statement of Compliance ...................................................................................................... 41 
13.1 
Monitoring Procedures ...................................................................................................... 42 
13.2 
Data Collection and Processing .................................................................................. 42 
14.1 
Study Supplies and Device Accountability ....................................................................... 43 
14.2 
Emprint™ Ablation System........................................................................................ 43 
14.3 
Planning Laptop .......................................................................................................... 43 
15.1 
General Information .......................................................................................................... 43 
15.2 
Study Contact Information .......................................................................................... 43 
15.3 
Retention of Records .................................................................................................. 44 
15.4 
Study Completion/Termination of Study .................................................................... 44 
16.0 
References ......................................................................................................................... 45 
17.0 
Appendices ........................................................................................................................ 47 

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2.0 Acronyms and Definitions 
 
Term 
Definition 
ADE 
Adverse Device Effect; Adverse event related to the use of an 
investigational medical device, including adverse events resulting from 
insufficient or inadequate instructions for use, deployment, 
implantation, installation, or operation, or any malfunction of the 
investigational medical device, as well as any event resulting from use 
error or from intentional misuse of the investigational medical device. 
AE 
Adverse event; 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 device. This includes events related to the 
investigational device or the comparator and procedures involved. 
ASADE 
Anticipated serious adverse device effect; an effect which by its nature, 
incidence, severity, or outcome has been identified in the risk analysis 
report (R0042262). 
CIP 
clinical investigational plan 
CRF 
Case report form 
CT 
computed tomography 
Device 
deficiency 
Inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety, or performance, such as malfunction, 
misuse or use error and inadequate labeling. 
EC 
Ethics committee (see IEC) 
eCRF 
Electronic case report form 
H&E 
Hematoxylin and eosin stain routinely used to evaluate the structural 
integrity of cells 
IEC 
Institutional ethics committee (see EC) 
IFU 
Instructions for Use; a manual or document accompanying a technical 
device that describes the directions by which the device should be 
used, applied, etc. 
Investigative 
Site 
An approved, participating study center/institution 
Investigator 
Either a principal, coordinating or sub-investigator, unless otherwise 
specified 
IRB 
Institutional Review Board 
ITT 
Intention to treat  
MITT  
Modified intention to treat 
MWA 
microwave ablation 
NADH 
β-nicotinamide adenine dinucleotide, reduced; assay used to determine 
cell viability 

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OR 
Operating Room 
 
RDC 
Remote data capture; internet-based data entry system used to enter 
and store study data points 
RTP 
remote temperature probe 
SADE 
Serious adverse device effect; adverse device effect that has resulted in 
any of the consequences characteristic of a serious adverse event 
SAE 
Serious adverse event; an adverse event that 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either 
resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body 
function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure or 
a body function, 
c) led to fetal distress, fetal death or a congenital abnormality or 
birth defect 
NOTE: 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. 
TEAE 
Treatment-emergent adverse event; any event not present prior to the 
initiation of the treatments or any event already present that worsens in 
either intensity or frequency following exposure to the treatments. 
USADE 
Unanticipated serious adverse device effect; serious adverse device 
effect which by its nature, incidence, severity or outcome has not been 
identified in the current version of the risk analysis report. 
3.1 Introduction 
3.2 
Background/Justification of Investigation 
 
Following CT-guided ablation of the tumor, a CT image will be performed to evaluate dose 
response.  The ablation zone will then be resected as part of the standard surgical procedure and 
the tissue specimen will be examined using histology to determine the completeness of tumor 
ablation. 
 
 
3.3 
Report of Prior Investigations 
The Covidien Emprint™ Ablation System under study in the current clinical investigational plan 
(CIP) was cleared by the U.S. FDA (K133821) in April 2014 and CE Mark was obtained in 
March 2014.  

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4.0 Identification and Description of Devices 
4.1 
Device Description 
Devices that will be used in this study are the Emprint™ Ablation System and Accessories 
(K133821).  Refer to the Emprint™ System IFU’s and User’s Guide for component descriptions. 
Additionally, the Emprint™ Procedure Planning Application, version 1.1 will be used to plan 
ablation dosing.  Refer to the Emprint™ Procedure Planning Application, version 1.1 User’s 
Guide for a description of the device. 
 
Please reference the Instructions for Use for the Emprint™ Ablation System and Accessories. 
The Emprint™ Ablation Generator, the Reusable Cable, the Pump, and the Cart are provided 
non- sterile and are not used in the sterile field. These four components are reusable.  Cleaning 
instructions for these components are provided in the Emprint™ Ablation System User’s Guide, 
Reusable Cable Instructions for Use, and the Emprint™ Cart Instructions for Use. 
 
The Emprint™ Percutaneous Antenna is provided sterile, is single use, and is intended to be used 
within the sterile field. 
 
4.2 
Indications 
The Emprint™ Ablation System is intended for use in percutaneous, laparoscopic, and 
intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non- 
resectable liver tumors. The System is not intended for use in cardiac procedures. 
 
 
The Emprint™ Procedure Planning Application is a stand-alone software product that allows 
physicians to visualize and compare CT image data. The display, annotation, and volume 
rendering of medical images aids in the intervention planning for video-assisted thoracoscopic 
surgery (VATS) and ablation procedures using the Emprint™ Ablation System. The software is 
not intended for diagnosis. 
 
 
4.3 
Warnings 
The following uses of MWA have not been studied: 
• Pregnant patients:  Microwave ablation procedures are not recommended for pregnant 
patients. Potential risks to the patient and/or fetus have not been established. 
• Patients with implantable pacemakers and other electronic implants. Microwave ablation 
procedures are not recommended for patients with cardiac pacemakers or other implanted 
electronic devices. Potential risks have not been evaluated. 
 
4.4 
Identification and Dosage 
Once all internal Covidien requirements are met, the Emprint™ Ablation System, the Emprint™ 
Percutaneous antennas, the reusable cable, ablation pump, and ablation cart and isolation 
transformer, will be shipped to each site.  Additionally, a laptop loaded with the Emprint™ 

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Procedure Planning Application, version 1.1, will be sent to each site prior to the study.  Each 
site will document the quantity, lot number and/or serial number of each piece of equipment 
upon receipt. 
 
 
5.1 Study Design 
 
 
5.2 
Overview 
This will be a post market prospective, non-randomized, single-arm, multicenter study, designed 
to demonstrate dose response of the Emprint™ Ablation System using a percutaneous approach 
in patients with metastatic or primary lung tumors. 
Up to 30 subjects who are scheduled for resection of metastatic or primary lung tumor(s) will be 
enrolled. Ablations will be carried out using a percutaneous approach at a dose (power and time 
setting) selected during procedure planning. NOTE: The procedure planning application will be 
used as an adjunct planning tool. While the physician prescribes the dose, the Emprint™ 
Procedure Planning Application overlays the 3-dimensional predicted ablation zone on the 
patient CT images, facilitating visualization of the predicted ablation zone relative to the target 
tumor. Once the ablation procedure is complete, the scheduled surgical tumor resection will be 
performed.  Up to 10 study sites in the United States and Europe will participate in this trial. 
 
 
5.3 
Primary Effectiveness Endpoint: Dose Response 
The primary endpoint of this study is dose response. Dose response will be assessed by 
comparing actual ablation zone size and volume to predicted ablation zone size and volume 
prescribed by the physician using the Emprint™ Procedure Planning Application, version 1.1. 
Dose response will be measured for each ablation zone using CT imaging immediately post 
ablation and prior to the surgical resection. 
 
All measurements used to determine dose response will be measured and reported by an 
independent core imaging lab. To assess dose response, the following measurements will be 
taken: 
 
 
Predicted Ablation Zone: 
 
5.2.1 Predicted Ablation Zone Size 
• The width (X), height (Y), and depth (Z) of the ablation zone, as depicted in the planning 
application annotation (via snapshot) will be measured and reported.  All measurements 
will be taken from the planes depicted in Figure 3.1. 
• Ablation zone volume as calculated by the planning application, captured in the 
snapshot. 
• Volume is calculated using the ellipsoidal approximation where A is width and is 
assumed to be axially symmetric, and B is height. 

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5.2.2 Predicted Ablation Zone Shape 
Ablation zone shape will be reported as a ratio of width (X) to height (Y) (Figure 3.1). A more 
spherical shape will be indicated by a ratio close to one. 
 
Actual ablation zone: 
 
5.2.3 Actual Ablation Zone Size 
• The width (X), height (Y), and depth (Z) of the ablation zone will be measured and 
reported, based on the planes depicted in Figure 3.1.  In instances where the ablation 
zone width is not fully circular, the shortest diameter for X will be measured. 
• Ablation zone volume will be measured using immediate post-procedure CT imaging and 
volumetric software package. 
 
5.2.4 Actual Ablation Zone Shape 
Ablation zone shape will be reported as a ratio of width (X) to height (Y) (Figure 3.1). A more 
spherical shape will be indicated by a ratio close to one. 
 
5.2.5 Confirmation of Dose Response: Ablation Zone Size 
Confirmation of dose response will be assessed by comparing the following measurements: 
• Predicted ablation size (width (X), height (Y), depth (Z)) vs. actual ablation zone size 
(width (X), height (Y), depth (Z)) 
• Predicted ablation zone volume as determined by the Procedure Planning Application vs. 
actual ablation zone volume 

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5.3 
Secondary Endpoint 
Complete tumor ablation immediately post-procedure will be measured for each target tumor 
using histologic analysis to evaluate complete ablation at the cellular level. 
 
 
5.3.1 Histological Analysis 
All histology samples will be evaluated by a core laboratory.  Both vital staining (Nicotinamide 
adenine dinucleotide (NADH) assay) and structural staining (hematoxylin and eosin; H&E) 
techniques will be used to evaluate cellular integrity within the ablation zone.   Additionally, 
pixel enumeration techniques will be used to evaluate histologic ablation (coagulation zone and 
hyperemic zone).  Once the samples have been received from the study site, the frozen sample 
will be serially sectioned into 8-10 micron increments, maintaining the axis along the previously 
inked black plane of division and continuing into the tissue beyond the ablation zone.  Three 
distinct regions of the ablation zone will be evaluated.  Four tissue sections from each region will 
be performed.  The first, third and fourth will be used for NADH staining.  The second section 
will be post-fixed in 10% buffered formalin in preparation for H&E staining. With binary 
staining characteristics, NADH staining assays will be used to assess viability in regions deemed 
equivocal on H&E stained samples. Positive staining is indicative of mitochondrial enzymatic 
activity and hence tissue viability, while a lack of staining is consistent with cellular death. 
Once the slides are processed and stained, the slides will be scanned into the Aperio™ digital 
image analyzer (Aperio ScanScope™).  The ScanScope is a high throughput automated slide 
scanner which scans the entire slide and stores the digital images in a tiff format, allowing 
viewing and digital analysis of the slides with the ImageScope™ viewer.  The Aperio 
ScanScope™ technology determines percent cell viability based on pixel quantification, where 
0% color pixels indicates 100% non-viable cells, ≤10% color pixels indicates ≥ 90% non-viable 
cells and >10% color pixels indicates <90% non-viable cells.  Complete tumor ablation using 
pixel quantification software will be defined as follows: 
 
Oncologic Characteristic 
Histological Findings 
Complete Ablation 
Negative Margin 
100% non-viable tumor cells 
Delayed Necrosis 
Weakly Positive Margin 
≥90% non-viable tumor cells 
Incomplete Ablation 
Positive Margin 
<90% non-viable tumor cells or 
tumor extends to the edge of the 
sample 
 
Samples will be taken from three distinct regions of the ablation specimen and will be analyzed. 
Percent cell viability will be averaged over the entirety of the transition zone from each region 
and will be recorded. 
 
5.4 Selection of Investigators and Training 
Board-certified thoracic surgeons and interventional radiologists, in accordance with United 
States and European Union and hospital guidelines, will be considered for participation as 

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investigators in this study. Physicians in training (residents, fellows) and Physician Assistants 
may assist the Study Investigator in any aspect of the procedure as per standard procedures and 
practices at his/her institution with the following exception: 
• Antenna placement 
Sites must have imaging available to ablate percutaneously, including either computed 
tomography (CT) equipment in the operating room or the ability to transport patients from the 
interventional radiology suite to the operating room. 
In addition, either a thoracic surgeon who will perform both the ablation and surgical procedure, 
or functional teams including both an interventional radiologist and a thoracic surgeon must be 
available at each site to participate in the study.  If the ablation procedure is carried out by a 
thoracic surgeon, a thoracic surgeon investigator(s) must be available to carry out both the 
ablation and the subsequent scheduled resection. 
Each Investigator and laboratory participating in the clinical trial and the associated clinical 
study staff will receive training on the clinical protocol, use of the Emprint™ Ablation System 
and Procedure Planning Application, as well as study-related methods for tissue sample 
preparation and CT image processing. Additionally, investigators will be trained on the device 
characteristics, device application and removal instructions, device dosage, device use and 
warnings associated with the technology per the IFU’s and User’s Guides. 
 
 
5.5 
Subject Selection and Enrollment 
After being informed of the nature of the study, the subject will provide written informed consent 
that has been approved by the appropriate IRB or EC of the respective clinical site. A total of up 
to 30 subjects will be enrolled in the study at up to 10 clinical sites in the United States and 
Europe. Subjects’ participation in the study may last 60-90 days after informed consent has been 
provided and eligibility has been confirmed. Subject enrollment will begin the day of the  
ablation procedure when the administration of the anesthesia for the ablation procedure begins 
and conclude after completion of the first standard of care post-operative follow-up visit. Prior to 
the administration of anesthesia, study eligibility will be confirmed the day of the ablation 
procedure. 
The surgical procedure will be performed per the institution’s standard practice. Patients 
scheduled for a pulmonary resection will be considered for study enrollment if they meet specific 
preoperative and intraoperative inclusion/exclusion criteria. The criteria for enrollment must be 
followed explicitly. If a subject does not meet all enrollment criteria and is inadvertently 
enrolled, the severity of the deviation will be reviewed by the Sponsor and assessments will be 
made to determine if the subject should remain in the study and if the site should continue to be 
allowed to enroll further subjects. 
 
 
5.5.1 Inclusion Criteria 
• Subject or authorized representative has provided informed consent 
• Subject is ≥18 years of age 

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• At least one pulmonary metastasis ≤ 3.0 cm in maximum diameter resulting from distant 
primary cancers or one primary lung cancer ≤ 3.0 cm in maximum diameter 
• Subject has been confirmed by a thoracic surgeon to be a surgical candidate for resection 
of the tumor targeted for ablation 
• Subject is willing and able to comply with all aspects of the treatment and evaluation 
schedule 
• 
≥ 1 cm of tumor-free lung parenchyma between target tumor and pleura or fissure 
 
5.5.2 Pre-procedure Exclusion Criteria 
• Contraindicated for surgery 
• Prolonged chest infection, defined as lung consolidation that requires hospitalization and 
greater than 10 days of antibiotics 30 days prior to surgery 
• Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or 
trachea 
• Tumor with pleural contact 
• Tumors located < 3 cm of staple lines or other metal objects 
• Patients diagnosed with GOLD Stage IV Emphysema 
• Uncontrollable coagulopathy 
• Patients unable to tolerate discontinued use of anti-coagulants prior to and during the 
ablation procedure 
• Subject is pregnant (documented by a positive pregnancy test according to hospital 
standard practices) or is actively breast-feeding 
• Subject has participated in an investigational drug or device research study within 30 
days of enrollment that would interfere with this study 
• The investigator determines that participation in the study may jeopardize the safety or 
welfare of the subject 
• Patients with implantable pacemakers and other electronic implants, in accordance with 
IFU 
 
5.5.3 Intraprocedural Exclusion Criteria 
• Incidental finding that the subject no longer meets the study eligibility criteria 
 
5.6 
Withdrawal of Subjects 
The reason for study exit will be documented on the applicable eCRF. In the event the 
subject withdraws consent during the study, the date of withdrawal will be documented. 
If the Study Investigator removes a subject from further study participation, supporting 
documentation must be in place for the rationale and date of removal. 
 
 
5.7 
Study Procedures 
 
 
5.7.1 Study Assessments Table 

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Patient 
Screening 
(within 30 days 
prior to 
surgery) 
Procedure 
Day(s) 
Post-operative 
Follow-up Visit 
Imaging 
Analysis by 
Core Lab 
Histology / 
Pathology 
Core Lab 
Informed consent 
X 
Preoperative 
eligibility criteria 
X 
Demographics 
X 
Medical / surgical 
history 
X 
Height and weight 
X 
Physical exam 
X 
Primary cancer 
X 
Pregnancy testa 
X 
X 
Study Start 
X 
Ablation Planning 
X 
Ablation start / stop 
times 
X 
Ablation Procedure 
start / stop times 
X 
Ablation dose 
X 
Acute 
hemorrhage/hemop 
tysis rate 
X 
Thermal injury rate 
X 
Acute 
pneumothorax 
incidence 
X 
Ablation-specific 
complications 
X 
Device 
malfunctions 
X 
Adverse events 
X 
X 
Study exit 
X 
Hematoxylin and 
eosin staining 
X 
Vital staining 
X 
Tumor Size 
analysis 
X 
X 

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Patient 
Screening 
(within 30 days 
prior to 
surgery) 
Procedure 
Day(s) 
Post-operative 
Follow-up Visit 
Imaging 
Analysis by 
Core Lab 
Histology / 
Pathology 
Core Lab 
Ablation volume / 
completeness 
X 
X 
Ablation zone Size 
X 
a. 
Pregnancy test to be administered to females of reproductive age who have not undergone previous sterilization 
or hysterectomy procedures. Should be administered only during the pre-procedure screening visit unless 
surgery is scheduled greater than 14 days from screening visit, in which case a pregnancy test should be 
administered prior to surgery. 
 
 
5.7.2 Informed Consent and Screening 
Subjects will be approached to obtain written informed consent prior to any study specific 
procedures being performed. The purpose of the study and the benefits and risks of the 
procedures will be explained to the subject. Subjects who agree to study participation must sign 
an IRB- or EC-approved informed consent form. Subjects will be informed that their 
participation in this study is voluntary and they may refuse to participate or discontinue from the 
study at any time. Subjects will be given the opportunity to ask the investigator questions so that 
they are adequately informed about the research. A copy of the signed informed consent will be 
offered to the subject and the informed consent process will be documented in source documents. 
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 by the investigator. 
 
 
5.7.3 Screening / Baseline Visit 
A screening/baseline visit will be performed within 30 days prior to the scheduled procedure to 
assess preoperative eligibility. The following assessments will be performed and the results 
recorded on the appropriate subject eCRFs: 
• Demographics 
o Age 
o Gender 
o Height 
o Weight 
o Body Mass Index 
o Race 
o Ethnicity 
• Laboratory tests 
• Pre-op Physical examination 
• Medical history 
• Location of primary cancer 
• History of prior thoracic surgery (if applicable) 
• Concomitant medications 

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• Comorbidities 
• Pregnancy test (if applicable) 
• Verification of preoperative eligibility criteria 
• Verification of surgical candidacy 
• Axial diameter of target pulmonary tumor along longest axis as determined through pre- 
operative CT imaging 
• Pulmonary tumor volume as determined through pre-operative CT imaging 
 
5.7.4 Screen Failures 
Subjects will be considered enrolled into the study after written informed consent has been 
provided and the ablation procedure is initiated (defined as the time point when the patient is 
administered anesthesia in preparation for the ablation procedure).  Subjects who provide study 
consent, but then are determined to be ineligible prior to the administration of anesthesia  in 
preparation for the ablation procedure, will be considered screening failures.  The reason for the 
screening failure will be clearly delineated on the applicable CRFs. 
 
 
5.7.5 Microwave Ablation 
In accordance with inclusion criteria, target tumors ≤3.0 cm in maximum axial diameter resulting 
from either distant primary cancers or primary lung cancers are eligible to be considered target 
tumors for the study analysis. Ablation dosing will be dependent on physician prescription based 
on target tumor size plus a minimum of a 0.5 cm margin, established during the ablation 
planning phase. 
 
 
Ablation Planning and Procedure 
If the pre-operative CT was taken greater than 30 days prior to the date of the procedure, a low- 
dose CT image will be taken prior to initiating the ablation procedure to confirm the tumor size 
and location prior to ablation planning.  The interventional radiologist or thoracic surgeon will 
use the pre-procedure CT in the Emprint™ Procedure Planning Application to initiate ablation 
planning.  Investigators will first launch the lung ablation planning application on the planning 
application laptop.  They will next import the baseline CT from a USB drive onto the planning 
laptop and verify the quality of the CT image as assessed by the planning application. Once the 
investigator has located the tumor, he or she will add a virtual target to the target tumor and take 
a snapshot of the final target annotation.  The investigator will then add an ablation zone that 
encompasses the target tumor with a minimum margin of 0.5 cm. They will select the 
appropriate antenna length from the dropdown menu, adjust the antenna trajectory to reflect 
desired insertion vector and mark the antenna insertion depth.  The investigator will then view 
the planned ablation zone and antenna trajectory in all available planes for three dimensional 
confirmation of placement, and make any necessary adjustments to the ablation zone and/or 
antenna trajectory to ensure a safe and effective planned ablation. Finally, the investigator will 
take a snapshot of the final plan to capture predicted ablation zone measurements and calculated 
predicted ablation volume. 

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Patients will be positioned on the CT table (e.g., supine, prone, or lateral) according to the 
location of the tumor, to achieve the shortest accessible path to the tumor in the position most 
tolerable to the patient. The microwave antenna will be applied percutaneously through a skin 
nick and will be advanced under CT guidance.  Once final placement of the antenna has been 
achieved, a CT image will be taken to verify final placement. 
Once antenna placement has been verified, the Emprint™ generator will be set by clinician to 
deliver the prescribed dose based on target tumor size plus a 0.5 cm margin and physician 
experience. Once the generator settings have been verified, the ablation will be initiated either by 
the investigator, using a foot switch, or radiology technician / scrub nurse, using the user 
interface on the generator. 
 
Once the ablation is complete, the antenna will remain in place and the third CT image will be 
taken to evaluate the characteristics of the resulting ablation zone.  The antenna will then be 
removed and the final CT image will be taken and will be used to identify adverse events that 
may have occurred during the ablation procedure. 
 
Once the final CT image has been acquired, the ablation zone will be resected as scheduled, by 
the thoracic surgeon per standard surgical practice.  The resected tissue will then be sent to the 
on-site pathology laboratory for sample preparation.  The prepared samples will be sent to a core 
laboratory for histologic analyses. 
 
If complications arise due to the microwave ablation, termination of the session will be 
determined at the discretion of the investigator according to the severity of the event and the 
extent of the intervention required. 
 
CT imaging using a multidetector row helical CT scanner (minimum 8 detector) will be 
employed four times during the patients’ enrollment in the study. The first three scans will be 
higher resolution to accurately measure target tumor size, antenna placement, and the ablation 
zone.  The final CT will be a low dose scan to assess the presence of bleeding or pneumothorax 
that occurred during the ablation. Scan parameters for the first three scans will be as follows: 
 
• 
Detector collimation – 1.5 mm or less 
• 
Pitch < 1 
• 
120kVp 
• 
Reference 100-140 mA (dependent upon body habitus).  Auto mA may be left on, but all 
other dose reduction should be turned off. 
• 
Scans will be performed with a breath hold at end inspiration with arms elevated over 
head if possible. 
• 
No IV contrast. 
• 
Images for 3D processing will be reconstructed at 1.5 mm with a 20% overlap using a 
standard kernel. 
 
Scan parameters for the fourth low dose scan will be as follows: 
 
• 
Detector collimation – 2.5 mm or less 
• 
120kVp 

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• 
Reference 40-80 mA (dependent upon body habitus) 
• 
Scans will be performed with a breath hold at end inspiration with arms elevated over 
head if possible. 
• 
No IV contrast. 
 
1. Pre-procedure Scan 
 
A Pre-procedure CT scan is only required on the day of the procedure if the standard of care CT 
scan was performed more than 30 days prior to the procedure date. 
 
Scan volume should extend from the clavicles through the lung bases. 
 
CT imaging either acquired the day of the procedure or up to 30 days prior will be used by 
Intrinsic, to confirm the location of the target tumor.  More specifically, all tumors will be 
measured in three dimensions (maximum dimension, maximum perpendicular dimension, and 
third perpendicular dimension) on pre-procedure CT images by the imaging core laboratory. 
Tumor volume will also be directly measured with volumetric post-processing.  Maximum 
transverse axial and perpendicular axial measurements will also be obtained to allow for 
comparison of tumor sizes with tumor sizes as recorded in most standard oncology trials. 
 
These images and required reconstructions must be sent to Intrinsic Imaging. 
 
2. Intra-procedural Scan 
 
When the antenna is in its final location prior to commencing ablation, the intra-procedural CT 
will be obtained. Scan volume should extend from 5cm above the superior margin of the tumor 
to 5cm below the inferior margin of the tumor to help minimize unnecessary imaging of tissue 
outside the area of immediate procedural concern. 
 
Intrinsic Imaging will use the image(s) of final placement of the antenna to evaluate technical 
accuracy, which is defined as correct positioning of antenna within the tumor. These data will 
specifically be used to evaluate any occurrence of incomplete ablation. 
 
These images and required reconstructions must be sent to Intrinsic Imaging. 
 
3. Post Procedure Scan (Antenna in Place) 
 
Scan volume should extend from the clavicles through the lung bases.  This CT scan will be 
obtained once the ablation is complete but with the antenna still in place. This Post-procedural 
imaging will be used to assess dose response. 

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These images and required reconstructions must be sent to Intrinsic Imaging. 
 
4. Post Procedure Scan (Antenna Removed) 
 
Scan volume should extend from the clavicles through the lung bases. 
 
This CT scan will be obtained to identify and evaluate acute adverse events that may have 
occurred during the ablation procedure. 
 
Anesthesia 
Anesthesia use will be determined by each site per standard of care and will be administered 
after ablation planning has occurred. 
 
 
Ablation Procedure 
An appropriate length Emprint™ percutaneous antenna (15 cm or 20 cm) will be placed into the 
target tumor under CT image guidance. An ablation zone will then be generated using a single 
application of a prescribed dose based on target tumor size. Following completion of the 
prescribed dose, a post ablation CT image will be taken.  The antenna will then be removed and 
the planned surgical resection will be conducted as scheduled. 
In addition, the following ablation-specific variables will be collected at the time of procedure: 
• Date 
• Ablation zone diameter of longest axis as determined through post-procedure CT imaging 
• Ablation zone volume as determined through post-procedure CT imaging 
• Ablation start and stop times 
• Total ablation time 
• Overall ablation procedure time from beginning of antenna placement to completion of 
the ablation. 
• Antenna size 
• Dose used 
• Adverse events 
• Device Deficiencies 
• Procedural failures (e.g., failure of microwave application, patient factors that 
prematurely stop procedure, etc.) 
 
 
5.7.6 Planned Surgical Resection 
Surgical resection and postoperative management will occur per standard local practice. The 
entirety of each target tumor and the microwave ablation zone should be resected. Every attempt 
will be made by each site to perform the surgical resection immediately after or the same day of 
the ablation procedure.  However, if an unforeseen event occurs resulting in an OR scheduling 
conflict, surgical resection performed  up to 36 hours after the ablation procedure is acceptable. 

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However, surgical resection of the ablation zone performed beyond 36 hours will be considered a 
protocol deviation. 
The following procedural variables will be collected: 
• Device and/or ablation procedure related adverse events as defined in section 6.6.2. 
 
5.7.7 Postoperative Evaluation / End of Study Visit 
The study subject will complete the study at the conclusion of the first post-operative visit, 
conducted per standard local practice, but occurring no later than 30 days after the scheduled 
resection. 
 
 
5.7.8 Sample Preparation for Histological Analyses 
Each study site will be supplied with a kit for sample preparation and shipment.  All samples and 
kits will be de-identified by labeling with an assigned study identification number.  Once the 
ablation zone is resected, the sample will be taken to the pathology lab on site. The resection 
will be examined to identify the antenna track.  Once identified, the tissue will be transected 
down the plane of the antenna track.  A digital photograph will be taken of each ablation cross 
section.  Half of the sample will then be kept by the onsite pathology lab for future analysis.  The 
plane of resection of the remaining half will be dyed with black India ink to maintain orientation 
for histologic examination. The India ink is fixed with Bouin's solution to prevent tracking of 
ink. The research half of the sphere is then sliced perpendicular to the initial cross section 
(quartered) to provide two samples.  One new cut section is inked green, fixed with Bouin's, 
submitted in formalin; the other cut section is inked blue, fixed with Bouin's and flash frozen. 
Both samples will be shipped overnight to the Core Histology Laboratory for analysis. Standard 
H&E and NADH technique will be performed on the tissue samples. 
 
 
6.1 Statistical Analysis 
 
 
6.2 
General 
A detailed statistical analysis plan will be finalized prior to performing any analyses to expand 
upon the statistical methods presented below. Summary tables will summarize data for all 
subjects together. 
 
6.3 
Sample Size Determination 
No pre-specified sample size calculations were performed for this post-market, prospective, non- 
randomized, single-arm, multicenter study. 
 
 
6.4 
Analysis Populations 
Intent-To-Treat (ITT): subjects enrolled into the study. 

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Modified ITT (MITT): ITT subjects who underwent the ablation procedure. 
 
 
6.5 
Demographics and Other Subject Characteristics 
Subject demographics and pre-treatment characteristics will be summarized for the ITT 
population. 
 
6.6 
Effectiveness Analysis 
Effectiveness analyses will be done for the MITT population. 
 
6.5.1 Primary Endpoint 
The primary endpoint is dose response immediately post-procedure (for each target tumor) and is 
defined as the percentage change from the predicted outcome to the actual outcome. The 
percentage change (calculated as 100*(A-P)/P) will be calculated for each target tumor, where 
P=predicted and A=actual.  The percentage change will be calculated for each tumor for the 
following measurements: 
• Ablation zone width (X) 
• Ablation zone height (Y) 
• Ablation zone depth (Z) 
• Ablation zone volume 
• Ablation zone shape 
For each of the above measurements, the percentage change for all tumors will be summarized. 
Summary will also be done by tumor type. 
The predicted values will come from the Procedure Planning Application and the actual values will come 
from the CT imaging. 
 
 
6.5.2 Secondary Endpoints 
The number and percentage of tumors which achieve complete tumor ablation, incomplete tumor 
ablation (delayed necrosis) and incomplete tumor ablation (positive margin) (both overall and 
according to tumor type) will be presented.  Ablation will be assessed using histology. A 95% 
exact binomial confidence interval will be calculated for each response. 
 
 
6.6 
Safety Analysis 
Safety analyses will be done for the MITT population. 
 
 
6.6.1 Exposure 
The dosing information (time, power) will be listed by subject. 

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6.6.2 Adverse Events & Complications 
Tables to summarize the incidence rates will be created for each of the following groups: 
• Adverse events 
• Serious adverse events 
• Adverse events leading to premature discontinuation 
• Adverse device effects (ADE) 
• Serious adverse device effects (SADE) 
• Unanticipated serious adverse device effects (USADE) 
• Adverse events by intensity 
• Adverse events by relationship to study product administration 
 
 
Adverse events that led to premature discontinuation from the study will be listed. Serious 
adverse events, SADE and USADE will also be listed. 
 
 
6.7 
Interim Analyses 
An interim analysis will be conducted once the first 15 tumors are ablated (preferably 
representative samples from each site). 
 
 
6.8 
Handling of Missing Data 
Missing data rules will be specified in the detailed statistical analysis plan. 
 
 
7.1 Risk/Benefit Analysis 
The purpose of this study is to create and evaluate an ablation zone created in patients already 
scheduled for surgical resection of metastatic or primary lung disease per standard practice. The 
ablation procedure is not intended to treat the target tumor. 
Since the Emprint™ Ablation system is similar in technology and indication to the existing 
MWA systems currently marketed in the U.S., EU and ROW, the potential harms associated with 
the Emprint™ Ablation System are the same as those presented in the literature and reported 
complaints.  More specifically, the current hazard analysis for the Emprint™ Ablation system 
identified the following lung specific potential harms related to use of the Emprint™ Ablation 
System: 

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• Pneumothorax 
• Skin Burn 
• Unintended Parenchymal Ablation, defined as lung parenchymal ablation extended > 1 
cm beyond predetermined volume of ablation safety margins 
• Tissue Tear 
• Microwave/Thermal Burn causing damage to extrapulmonary structure (e.g., pleural 
burn, Diaphragmatic Paresis or perforation, Vessel Thrombosis, Mediastinal burn) 
• Bleeding (e.g., Hemorrhage, Hemothorax, Hematoma, Hemoptysis) 
• Infection (e.g., Abscess, Pneumopathy) 
• Procedural Delay (e.g. delayed or canceled surgery) 
• Foreign Object in Body 
 
The risk analysis assumes the system is operated by quality, properly trained personnel. The 
overall residual risk after design risk mitigation strategies and/or design control was deemed 
acceptable in the Risk Management Report for the Emprint™ Ablation System. 
 
7.2 
Anticipated Risks Associated with Lung Tumor Ablation Reported in Literature 
and by Investigators 
Based on the evidence summarized in Section 3.2, potential risks associated with lung tumor 
ablation with the Emprint™ Ablation System include but are not limited to: 
• Pneumothorax (9,10,12) 
o Mild severity (reported incidence: 4.6% - 27%) 
o Moderate or severe severity (reported incidence: 3.9% -12%) 
• Pleural Effusion 
• Skin burns (reported incidence: 0.8 % - 4.3%) (9,10,16) 
• Acute respiratory distress (reported incidence: 2%) (9) 
• Self-limiting hemoptysis (reported incidence: 4.6% – 7.25%) (9,10,12,14) 
• Hemorrhage requiring additional intervention treatment (reported incidence: 1-2%) 
(investigator experience) 
• Empyema development (reported incidence: <5%) (17) 
• Post-ablation syndrome, defined as productive cough with or without minor hemoptysis, 
residual soreness in the treated area, and fever occurring several days post-ablation 
(reported incidence: 2%) (9) 
• Post-procedural pain (reported incidence: 2%) (9) 
• Slight risk of bleeding from placement of the microwave ablation antenna 
• Insufficient coagulation (single report in MAUDE database) 
• Nerve Injury (e.g., stallate ganglion, intercostal and phrenic nerves) 
 
Oncologic and surgical principles should not be compromised by the addition of tumor ablation 
to the surgical resection procedure. The tumor will be completely excised and the single-use 
antenna will not be used again in any living tissue. Thus, this study protocol does not impart any 
risk of spreading tumor cells. 

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Reproductive and developmental toxicology studies in animals to evaluate the potential for AEs 
on reproductive ability and effects on the embryo/fetus have not been conducted. Subjects who 
are pregnant (documented by a positive pregnancy test) or are actively breast-feeding are 
excluded per study protocol. 
 
 
7.3 
Risks Associated with Additional Radiation Exposure for Study-Related CT 
Imaging 
There are risks associated with the use of CT. The main risks are those associated with the 
increased possibility of cancer induction from x-ray radiation exposure. Normally, an individual 
may be exposed to approximately 3 millisieverts of radiation each year just from background 
environmental radiation, such as radon and cosmic rays. In higher elevation areas an individual’s 
background exposure can be as high as 10 millisieverts per year.  The expected additional 
exposure due to the CT procedures in this study would be in the range of 12 to 30 millisieverts. 
 
The probability for absorbed x-rays to induce cancer or heritable mutations leading to genetically 
associated diseases in offspring is thought to be very small for radiation doses of the magnitude 
that are associated with CT procedures and for any one person the risk of radiation-induced 
cancer is much smaller than the natural risk of cancer.  However, an individual’s risk of harmful 
effects may increase if they are exposed to additional procedures that involve radiation such as x- 
rays or if additional CT scans are required for care. 
 
7.4 
Risks Associated with Study Procedure 
There is a potential for longer procedure time; however, because other aspects of the planned 
surgical resection procedure can be conducted during the ablation, the addition of ablation to the 
procedure is unlikely to cause a significant increase in procedure time. 
Additionally, there is a risk that based on the length and execution of the ablation procedure, the 
standard of care surgical resection may need to be rescheduled to the day after the ablation 
procedure, resulting in an overnight hospital stay for the study subject. This is a small risk, 
however, if this occurs, all costs related to the additional overnight hospital stay will be incurred 
by the Sponsor. 
 
 
7.5 
Potential Benefits to the Subject 
Because this study will be conducted in patients already scheduled for surgical resection of 
metastatic or primary lung tumors, the study protocol will not impart significant benefits beyond 
the benefit of lung resection alone. 
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 inoperable lung tumors 
and patients. 

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8.1 Adverse Events, Complications, and Product Complaints 
Since this product is a legally marketed product, all SAE’s regardless of cause, device and/or 
ablation procedure related AEs or complications and product complaints will be reported to 
Covidien Post Market Vigilance for documentation and investigation according to CI-007D. 
8.2 
Adverse Event (AE) 
An Adverse Event 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 medical device. 
Adverse events will be collected starting from the initial administration of anesthesia to the 
patient until conclusion of the first post-operative follow-up visit. All enrolled subjects will be 
evaluated for Adverse Events regardless of whether or not the subject received the planned 
ablation and resection. 
It should be noted the risks identified above are similar to those noted for standard lung 
resection.  In some cases, it will be impossible to differentiate surgery induced AE’s from 
ablation induced AEs, specifically for AE’s that occur after surgery. This should be noted as a 
limitation in quantifying device and/or ablation procedure related AEs . 
 
8.3 
Serious Adverse Event (SAE) 
A Serious Adverse Event is an adverse event that has 
a) led to death, 
b) led to serious deterioration in the health of the subject, that either resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function, 
NOTE: 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. 
 
 
8.4 
Adverse Device Effect (ADE) 
An Adverse Device Effect is an adverse event related to the use of a medical device. 
This definition includes adverse events resulting from insufficient or inadequate instructions for 
use, deployment, installation, or operation, or any malfunction of the medical device. 
This definition includes any event resulting from use error or from intentional misuse of the 
medical device. 

 
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8.5 
Serious Adverse Device Effect (SADE) 
A Serious Adverse Device Effect is an adverse device effect that has resulted in any of the 
consequences characteristic of a serious adverse event. 
 
 
8.6 
Unanticipated Serious Adverse Device Effect (USADE) 
An Unanticipated Serious Adverse Device Effect is a serious adverse device effect which by its 
nature, incidence, severity, or outcome has not been identified in the current version of the risk 
analysis report. 
 
 
8.7 
Definitions of Specific Adverse Events 
This list is not meant to be all inclusive but representative of specific adverse events relevant to 
the ablation procedure and/or outcome. 
 
 
• Pneumothorax, defined as clinically significant: expanding and requiring a chest tube 
insertion or non-clinically significant: radiologically apparent in a non-symptomatic 
patient 
o The incidence of non-clinically significant pneumothoraxes will be collected as a 
safety endpoint only and will be used to determine trends for follow on studies. 
Clinically significant pneumothoraxes will be reported as AE’s if a chest tube is 
needed prior to the surgical intervention. 
• Pleural Effusion, defined as the accumulation of excess fluid in the pleural cavity after 
the ablation procedure and prior to the initiation of the surgical procedure 
• Bleeding – an outcome of the failure to achieve or maintain hemostasis that results in 
o Hematoma 
o Hemorrhage (includes parenchymal pulmonary hemorrhage, hemothorax, and 
hemoptysis), defined by a change in vital signs sometimes requiring resuscitation 
Bleeding will be assessed after the ablation procedure and prior to initiation of the surgical 
resection and will be evaluated based on the following CTCAEv.4 definitions: 

 
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• Device Deficiencies including but not limited to: 
o Device components left inside the subject – any part of the antenna breaking and 
dislodging in the patient 
o Generator malfunction leading to premature termination of ablation cycle 
• Unintended Parenchymal Ablation, defined as lung parenchymal ablation extended > 1 
cm beyond predetermined volume of ablation safety margins 
• Microwave/Thermal Burn causing damage to extrapulmonary structures (e.g., pleural 
burn, Diaphragmatic Paresis or perforation, Vessel Thrombosis, Mediastinal burn) 
o Grade 1: minimal symptoms, no intervention 
o Grade 2: medical intervention, debridement 
o Grade 3: moderate/major debridement, reconstruction 
• Nerve Injury (e.g. stallate ganglion, intercostal and phrenic nerves), defined as one of the 
following: 
o Neuropathic pain or dysesthia in the distribution of an intercostal nerve adjacent 
to the ablation zone 
o Horner’s Syndrome (proptosis, meiosis and anhydrosis of the ipsilateral eye) 
related to thermal injury of a high upper lobe tumor situated medially abutting the 
paraspinal region 
o New paralysis of the ipsilateral hemidiaphragm related to thermal injury of the 
phrenic nerve 
• Musculoskeletal Fracture- if immobilization needed or operative intervention is required 
• Soft Tissue Tear resulting in partial resection of injured area 
• Allergic/Toxic Reaction 

 
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8.8 
Adverse Event Severity Classification 
Severity will be defined according to the following CTCAEv.4 criteria: 
 
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 
 
 
8.9 
Adverse Event Relationship Classification 
Relationship to study product administration will be determined as follows: 
• No Relationship: No relationship between the AE and the administration of study 
treatment and a known relationship to other etiologies such as concomitant medications, 
surgical procedure, or subject’s clinical state. 
• Possible Relationship: An AE that follows a reasonable temporal sequence from 
administration of the study treatment and follows a known response pattern to the study 
treatment but could have been produced by the participant’s clinical state or by other 
therapies. 
• Probable Relationship: An AE that follows a reasonable temporal sequence from 
administration of the study treatment; follows a known response pattern to the study 
treatment; and cannot be reasonably explained by the known characteristics of the 
participant’s clinical state or by other therapies. 
• Definite Relationship: An AE that follows a plausible temporal sequence from 
administration of the study treatment and follows a known response pattern to the study 
treatment. The reaction cannot be reasonably explained by the known characteristics of 
the subject’s clinical state or other modes of therapy administered to the subject. 
• Unknown/Impossible to Determine: Given the information available, sequence and 
timing of events, it is unknown or impossible to determine the relationship of the AE 
with the study treatment. 

 
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8.10 Adverse Event Outcome Classification 
Outcome of the event will be defined according to the following: 
• Resolved: The event has fully resolved at the end of the study. 
• Resolved with sequelae: The event has resolved, but retained pathological conditions 
resulting from the prior disease or injury. 
• Continuing: The event is ongoing at the end of the study. 
• Death: This event is determined to be the cause of death. 
 
8.11 Adverse Event Recording and Reporting 
In addition to the adverse event reporting required for post market device reporting, adverse 
events occurring during the ablation procedure and/or attributed to the ablation procedure will be 
recorded in an AE CRF and reported in clinical study reports. 
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. Adverse events will be monitored 
until conclusion of the first post-operative follow-up visit unless the Investigator determines the 
event is related to the device or ablation procedure, in which case they will be monitored until 
resolution if possible. Medical care will be provided, as defined in the informed consent, for any 
device or ablation procedure related AEduring study participation. Adverse events will be 
collected on an AE eCRF and applicable source documentation. To the extent possible, the event 
to be recorded and reported is the event diagnosis as opposed to event symptoms (e.g., fever, 
chills, nausea and vomiting in the presence of a clinically diagnosed infection is to be reported as 
infection only). For the purposes of this protocol, only those AEs occurring after initial 
administration of anesthesia will be recorded. 
The following should not be considered an AE: 
• A condition requiring a preplanned procedure unless the condition worsened since 
screening 
• A preexisting condition found as a result of screening, unless the condition has worsened 
since the screening visit, and is noted on the day of the procedure 
All AEs observed during the ablation procedure for this study, regardless of severity or 
relationship to the device will be recorded on the appropriate CRF and reported in clinical study 
reports. Only device and/or ablation procedure related AE’s deemed possible, probable, or 
definitely related will be reported during the surgical resection. To ensure reported events can be 
attributed to the device and/or ablation procedure, it is strongly recommended that a safety 
evaluation be performed immediate post-ablation procedure to capture acute events and again 
prior to the scheduled surgical resection. 

 
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8.12 Notification to Authorities 
The following events are generally considered reportable during the course of this study and 
should be reported to the sponsor within 24 hours of the time the Site learns of the event: 
• any ADE, SADE, SAE, or USADE 
• any Investigational Medical Device Deficiency that might have led to an SADE if 
o a) suitable action had not been taken or 
o b) intervention had not been made or 
o c) if circumstances had been less fortunate 
• new findings/updates in relation to already reported events. 
Events will be reviewed by Covidien or designee and will be reported to comply with local 
standards and mandatory reporting practices. 
 
 
9.0 Device Deficiencies 
A Device deficiency is an inadequacy of a medical device related to its identity, quality, 
durability, reliability, safety, or performance, such as malfunction, misuse or use error and 
inadequate labeling. 
All Emprint™ Ablation System device deficiencies will be documented on the appropriate 
Device deficiency eCRF and the device should be returned to Covidien for analysis, if possible. 
Instructions for returning the device will be provided. Device deficiencies should also be 
documented in the subject’s medical record. 
Device deficiencies are NOT to be reported as AEs. However, if there is an AE that results from 
a device deficiency, that specific event would be recorded on the appropriate eCRF. 
 
 
10.0 
Safety Committees 
The sponsor will employ a comprehensive safety plan for this study comprised of the following 
components: 

 
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10.1 Independent Medical Monitor 
The Sponsor will utilize an Independent Medical Monitor to provide an independent medical 
review and adjudication of pre-specified adverse events in support of protocol defined endpoint 
data. The Independent Medical Monitor is a qualified, board-certified Interventional Radiologist. 
Refer to the Independent Medical Monitor charter for additional details. 
 
 
11.0 
Steering Committee 
The Steering Committee will consist of the Principal Investigator at each clinical site as well as 
appropriate members of Covidien Clinical and Medical Affairs. The role of the steering 
committee is to make recommendations on the design and conduct of the study, the analysis of 
data, and the communication of results in alignment with the Covidien Publication and 
Authorship Policy. 
 
 
12.0 
Compliance 
 
 
12.1 Statement of Compliance 
This clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki, Clinical investigation of medical devices for human 
subjects — ISO 14155:2011 Good Clinical Practice, and any regional or national regulations, as 
appropriate. 
The clinical investigation will not begin until all necessary approvals/favorable opinions are 
obtained from the appropriate IRB or IEC or regulatory authority, as appropriate. Should an IRB 
or IEC 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 offered for publication at the 
conclusion of the study, if participating investigators believe the data warrants publication in an 
appropriate journal. 
 
 
12.2 
Protocol Compliance 
No changes to the protocol will be permitted without the written approval from Covidien and the 
IRB/EC. The investigator must notify Covidien and the reviewing IRB/EC of any deviation from 
the Investigational Plan when specific to the protection of the life or physical well-being of a 
subject in an emergency. Such notice must be given as soon as possible, but in no event later 
than 5 working days after the emergency has occurred. Except in such an emergency, prior 
written approval by Covidien is required for changes in or deviations from the Plan. If these 
changes or deviations affect the scientific soundness of the Plan or the rights, safety, or welfare 
of human subjects the IRB/EC will also be notified. All other deviations will be reported per the 
site’s IRB/EC deviation policy. Should any deviations from the Investigational Plan occur, these 

 
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will be reviewed by Covidien for their clinical significance. If the event is performed without 
written approval from all parties, the investigator may be terminated from the study. 
 
 
13.1 
Monitoring Procedures 
Site visits will be conducted by an authorized Covidien representative to inspect study data, 
subjects’ medical records, and eCRFs in accordance with ISO 14155:2011 Good Clinical 
Practices 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 Covidien and/or designee(s) employed by 
Covidien to review completed eCRFs, IEC or 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 Covidien 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 
review training records to ensure all study staff are trained on the study protocol and use of the 
study devices. If the monitor discovers that an investigator is not complying with the signed 
Investigator Agreement, the investigational plan, applicable laws, or any conditions of approval 
imposed by the reviewing IEC or IRB the monitor will report to the Sponsor and take such steps 
necessary to promptly secure compliance. If compliance cannot be secured, device shipments to 
the investigator may be discontinued and the investigator’s participation in the investigation 
terminated. The monitor shall also require such an investigator to dispose of or return the device, 
unless this action would jeopardize the rights, safety, or welfare of a subject. 
 
 
13.2 Data Collection and Processing 
This study will utilize an electronic database and eCRF.  In order to accurately collect all 
information, subject worksheets will be provided for study specific data (specific operative data 
points, etc.) not found in the medical records and will be considered the source document. All 
data requested on the eCRF are considered required. Data points not collected and/or recorded 
will be considered deviations unless otherwise specified. The Principal Investigator must ensure 
the accuracy and completeness of the recorded data and then provide his/her electronic signature 
on the appropriate eCRFs. The Investigator’s electronic signature for specific eCRFs 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 queries will be created in LiveTrial (RDC) system and will be issued to 

 
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the site for appropriate response. The site staff will be responsible for resolving all queries in the 
database. 
 
 
14.0 
Study Supplies and Device Accountability 
 
 
14.1 Emprint™ Ablation System 
The Emprint™ Ablation System will be provided to each site upon Sponsor collection and 
approval of all required regulatory documentation. The device will be labeled “Exclusively for 
Clinical Investigations” and should be stored in a secure (locked) area under the appropriate 
storage conditions. Access should be limited to designated study staff only. Device 
accountability logs will be provided to the site. It is the site’s responsibility to document the 
receipt (maintain shipping logs), disposition of the product (per subject use, including amount 
used, amount remaining, etc.), transfer (if applicable) and return of all unopened study devices. 
 
 
14.2 Planning Laptop 
A laptop loaded with the ablation planning application software will be provided prior to the start 
of the study.  It is the site’s responsibility to record the serial number of the laptop upon receipt. 
Access to and use of the planning laptop should be limited to designated study staff only.  Once 
the study has concluded, the planning laptop will be returned to Covidien. 
 
15.1 
General Information 
 
 
15.2 Study Contact Information 
Questions regarding safety or medical procedures should be directed to Medical Affairs. All 
other questions should be directed to Clinical Affairs. 
 
 
Amanda Cafaro, RN, BSN 
Director Clinical Research  
 
Jaime Kean, Ph.D. 
Program Manager, Clinical 
Affairs  
 

 
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15.3 Retention of Records 
The investigator will maintain the records of the study including all pertinent correspondence, 
the study protocol with any/all amendments, all correspondence with and approval from the IEC, 
the clinical trial agreement, the Investigator Agreement, investigational device accountability 
records, individual subject records, and signed informed consent forms. Subject files and other 
source data must be kept for a period of not less than 2 years after the date on which this 
investigation is terminated or completed. Records may need to be maintained by the Principal 
Investigator for a longer duration if national regulations require or if agreed to in writing with 
Covidien. All data and documents should be made available if requested by relevant authorities. 
 
 
15.4 Study Completion/Termination of Study 
Covidien reserves the right to discontinue the study at any stage, with suitable written notice to 
all investigators, all reviewing IRBs or IECs, and FDA or Competent Authorities. Similarly, 
investigators may withdraw from the study at any time, subject to providing written notification 
to Covidien 30 days prior to the date they intend to withdraw. However, Covidien and 
investigators will be bound by their obligation to complete the follow-up of subjects already 
participating in the study. The subjects must be followed according to the clinical protocol, and 
information obtained during subject follow-up shall be reported to Covidien on the appropriate 
eCRF. 
 
16.0 
Appendices 
 
There are no appendices to this protocol.