A Multicenter Observational Registry to Develop Ablation Parameter Guidance for Microwave Liver Ablation of Soft Tissue Lesions
Conditions: Cancer of the Liver, Liver Cancer, Neoplasms, Liver
Sponsor: Ethicon, Inc.

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A Multicenter Observational Registry to Develop Ablation 
Parameter Guidance for Microwave Liver Ablation of Soft 
Tissue Lesions 
 
Protocol Number: NEU_2017_04 
 
 
Document 
Effective Date 
Original (version 1.0) 
19 April 2019 
Amendment 1 (version 2.0) 
13 June 2019 
Amendment 2 (version 3.0) 
20 April 2020 
Amendment 3 (version 4.0) 
21 July 2021 
Sponsor: 
NeuWave Medical, Inc. 
NeuWave Medical, Inc. is a subsidiary of: 
Ethicon, Inc. 
 
 
 
CONFIDENTIALITY STATEMENT 
The information in this document contains trade secrets and commercial information that are privileged or 
confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. In 
any event, persons to whom the information is disclosed must be informed that the information is privileged 
or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally 
to all future information supplied to you which is indicated as privileged or confidential. 

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TABLE OF CONTENTS 
1.0 
RESPONSIBLE PARTIES INVOLVED IN THE REGISTRY ............................... 7 
2.0 
STATEMENT OF COMPLIANCE ....................................................................... 7 
3.0 
INVESTIGATOR SIGNATURE .......................................................................... 8 
4.0 
PROTOCOL SUMMARY.................................................................................... 9 
5.0 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ..................... 16 
6.0 
REGISTRY OBJECTIVES AND ENDPOINTS ................................................... 16 
6.1 
Primary Objective ............................................................................................... 16 
6.2 
Primary Endpoints .............................................................................................. 16 
6.3 
Secondary Endpoints ......................................................................................... 17 
7.0 
REGISTRY DESIGN .......................................................................................... 18 
7.1 
Overall Registry Design and Plan – Description ................................................. 18 
7.2 
Enrollment .......................................................................................................... 18 
7.3 
Inclusion Criteria ................................................................................................ 18 
7.4 
Exclusion Criteria ............................................................................................... 18 
7.5 
Prior and Concomitant Therapy ......................................................................... 19 
7.6 
Screen Failures .................................................................................................. 19 
7.7 
Removal of Patients from the Registry ............................................................... 19 
8.0 
REGISTRY POPULATION ................................................................................. 20 
9.0 
INVESTIGATOR RESPONSIBILITIES ............................................................... 20 

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9.1 
Good Clinical Practices ...................................................................................... 20 
9.2 
Institutional Review Board/Ethics Committee ..................................................... 21 
9.3 
Patient Information and Consent ........................................................................ 21 
10.0 
REGISTRY INTERVENTIONS ........................................................................... 22 
11.0 
REGISTRY PROCEDURES AND EVALUATIONS ............................................ 22 
11.1 
Procedure Description(s) ................................................................................... 22 
11.2 
System Overview ............................................................................................... 22 
11.3 
Central Review Committee ................................................................................ 24 
12.0 
REGISTRY SCHEDULE .................................................................................... 24 
12.1 
Visit 1 – Screening ............................................................................................. 24 
12.2 
Visit 2 – Ablation Procedure ............................................................................... 25 
12.3 
Post-ablation Follow-up Visits ............................................................................ 27 
12.4 
Unscheduled Visits ............................................................................................ 28 
13.0 
ASSESSMENT OF SAFETY .............................................................................. 28 
13.1 
Adverse Events .................................................................................................. 29 
13.2 
Reporting Adverse Events ................................................................................. 32 
13.3 
Product Complaints ............................................................................................ 33 
14.0 
DEVIATIONS FROM THE CLINICAL REGISTRY PLAN ................................... 33 
15.0 
REGISTRY PRODUCT ...................................................................................... 34 
16.0 
CLINICAL MONITORING ................................................................................... 34 
17.0 
STATISTICAL METHODOLOGY ....................................................................... 35 

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17.1 
Statistical and Analytical Plans .......................................................................... 35 
17.2 
Registry Design .................................................................................................. 35 
17.3 
Treatment Assignment ....................................................................................... 35 
17.4 
Interval Windows ................................................................................................ 35 
17.5 
Primary Endpoint and Associated Hypotheses .................................................. 35 
17.6 
Levels of Significance ........................................................................................ 36 
17.7 
Analysis Sets ..................................................................................................... 36 
17.8 
Sample Size Justification ................................................................................... 36 
17.9 
Analyses to be Conducted ................................................................................. 36 
18.0 
ETHICS/PROTECTION OF HUMAN PATIENTS ............................................... 39 
18.1 
Institutional Review Board/Ethics Committee ..................................................... 39 
18.2 
Applicable Regulations ....................................................................................... 39 
18.3 
Patient Information and Consent ........................................................................ 39 
19.0 
DATA HANDLING AND RECORD KEEPING .................................................... 39 
19.1 
Data Elements ................................................................................................... 39 
19.2 
Source Documents ............................................................................................ 42 
19.3 
Electronic Data Capture ..................................................................................... 43 
19.4 
Data Collection ................................................................................................... 43 
19.5 
Medical Dictionary Coding ................................................................................. 43 
19.6 
Data Correction .................................................................................................. 43 
19.7 
Data Privacy ...................................................................................................... 44 
20.0 
REGISTRY Suspension or Termination ............................................................. 44 
21.0 
Data and Publication Policies ............................................................................. 44 
22.0 
Supplements ...................................................................................................... 45 

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22.1 
Numeric Pain Rating Scale ................................................................................ 45 
22.2 
Glossary ............................................................................................................. 46 
23.0 
Document Filing ................................................................................................. 48 
24.0 
Scientific References ......................................................................................... 49 

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1.0 
RESPONSIBLE PARTIES INVOLVED IN THE REGISTRY 
A list of all responsible parties, such as laboratories, medical monitors, and contract research 
organizations, who are involved in the operations of the registry is filed in the Sponsor’s Trial Master 
File. The names of the individuals and corresponding phone numbers who should be contacted 
regarding the conduct of the registry, adverse events, safety issues, and complaints are provided in 
the Site Investigator File. 
 
 
2.0 
STATEMENT OF COMPLIANCE 
This registry will be conducted in accordance with specific provisions of the associated Institutional 
Review Board (IRB)/ Ethics Committee (EC) and in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki, and that are consistent with Good Clinical Practice (GCP) 
and the applicable national and regional regulatory requirement(s). 

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3.0 
INVESTIGATOR SIGNATURE 
I have read this protocol and agree to conduct this clinical investigation in accordance with the design 
and specific provisions outlined herein. I understand the protocol, and I understand I am solely 
responsible to ensure the investigation is conducted in accordance with Good Clinical Practices 
(GCP), applicable country regulations, the Declaration of Helsinki, the signed clinical trial agreement 
with Sponsor, and with the protocol outlined herein. I will conduct this registry as outlined therein and 
will make reasonable effort to complete the registry within the time period designated by the Sponsor. 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me 
who will assist in the conduct of this registry. I will discuss this material with them to ensure they are 
fully informed regarding the device and the conduct of the registry. 
I will fulfill the requirements of my Institutional Review Board (IRB) / Ethics Committee (EC), or other 
oversight committee, to ensure complete and continual oversight of this clinical registry. I will use an 
Informed Consent Document approved by the Sponsor and my reviewing IRB/EC. 
I agree to report all information or data in accordance with the protocol and, in particular, I agree to 
report any serious adverse events, device-related adverse events, or procedure-related adverse 
events, as defined in this protocol, to the Sponsor, and comply with all adverse event reporting 
requirements of my reviewing IRB/EC. I agree to permit the Sponsor, its authorized representatives, 
my reviewing IRB/EC, and any regulatory authority/body access to all records relating to the clinical 
investigation. 
The below signature confirms I have read and understood this protocol and its associated 
amendments or attachments and will accept respective revisions or amendments provided by the 
Sponsor. I agree to comply with all other requirements regarding the obligation of clinical 
investigators and all other pertinent requirements of the Sponsor and government agencies. 
 
 
 
Principal Investigator Signature 
Date 
[Principal Investigator printed name] 
Name of the site 
Address of the site 
City, State 
Country 
 
PLEASE RETAIN A COPY FOR YOUR RECORDS 

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4.0 
PROTOCOL SUMMARY 
 
Full Title 
A Multicenter Observational Registry to Develop Ablation 
Parameter Guidance for Microwave Liver Ablation of Soft Tissue 
Lesions 
Protocol Number 
NEU_2017_04 
Short Title 
NOLA (NeuWave Observational Liver Ablation) Registry 
IDE/IND number 
N/A 
Sponsor 
NeuWave Medical, Inc. 
Indication 
Ablation (coagulation) of soft tissue in percutaneous, open 
surgical, and in conjunction with laparoscopic surgical settings, 
including the partial or complete ablation of non-resectable liver 
tumors. 
Registry Article 
Description 
• 
NEUWAVE Microwave Ablation System and Accessories 
(originally marketed as the “Certus 240 140 2.45GHz 
Ablation System and Accessories”; hereafter referred to as 
“NEUWAVE Microwave Ablation System”). 
• 
NEUWAVE Microwave Ablation System with Ablation 
Confirmation. 
Registry Design 
This is a multicenter, observational registry that follows patients 
for a total of 5 years from the date of the first liver ablation 
procedure with the NEUWAVE Microwave Ablation System. 
Sample Size 
N = up to 1500 patients ablated. 
Registry Population 
Patients with at least one soft-tissue liver lesion ablated with the 
NEUWAVE Microwave Ablation System or NEUWAVE 
Microwave Ablation System with Ablation Confirmation. 
Geographic Areas 
Starting at sites in the United States and expanding to regions 
where NEUWAVE Microwave Ablation Systems are available, 
including EMEA and Asia. 
Registry Duration 
Enrollment: ~2 years 
Follow up: 5 years 
Procedure(s) 
Description 
Patients who meet the eligibility criteria will undergo microwave 
ablation (MWA) with the NEUWAVE Microwave Ablation System 
with or without Ablation Confirmation of at least one soft-tissue 
liver lesion, in accordance with the study site’s standard-of-care 
(SOC) practices. 
Primary Objective 
The primary objective of this registry is to compile data that will 
be analyzed at various timepoints, to understand the impact of 
selected parameters on procedure/patient outcomes. 

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Primary Endpoints 
• 
Technical success (perioperative endpoint) 
• 
Technique efficacy (short term endpoint) 
• 
Target lesion recurrence (local recurrence) rate (long term 
endpoint) 
Secondary 
Endpoints 
• 
Secondary efficacy rate 
• 
Regional recurrence rate at a separate location in the liver 
• 
Recurrence-free survival 
• 
Overall survival 
• 
Economic impact of ablation 
• 
Incidence of reportable Adverse Events/Serious Adverse 
Events (AEs/SAEs) 
• 
Numeric Pain Rating Scale 
• 
Quality of Life Questionnaires (QLQ-C30 and QLQ-HCC18) 
Inclusion Criteria 
1) Patients who underwent or are scheduled to undergo a 
microwave ablation of one or more liver lesions with the 
NEUWAVE Microwave Ablation System per the device’s 
Instructions for Use (IFU). 
2) Patients with signed informed consent (or waiver approved by 
IRB/EC) who are willing to comply with the assessment 
schedule, and willing to have data included in the database. 
3) Patients > 22 years old at the time of informed consent (or 
waiver approved by IRB/EC). 
Exclusion Criteria 
1) Patients with a life expectancy of less than 1 year, in the 
opinion of the treating physician. 
2) Use of microwave ablation purely as a transection tool, 
rather than focused liver lesion ablation. 
3) Patient is currently participating, or planning to participate, 
in another NeuWave/Ethicon-funded clinical trial or registry 
studying microwave ablation in the liver. Note: roll-over 
patients from previous NeuWave trials are permitted. 
Safety Assessments 
Patients will be assessed per the Schedule of Assessments for 
AEs that are procedure- or device-related and all SAEs. 

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Statistical Analysis 
Categorical variables will be summarized descriptively by 
frequencies and associated percentages. Continuous variables 
will be summarized descriptively by number of patients, mean, 
standard 
deviation, 
median, 
minimum, 
and 
maximum. 
Confidence intervals will also be provided for procedure-related 
variables. 
Models will be built to explore the relationship between technical 
success, technique efficacy, and secondary efficacy rate, and 
ablation procedure, patient, and provider parameters. Time to 
event analyses will be used for target lesion recurrence rate, 
recurrence-free survival, and overall survival. 
Interim Analysis 
There are no plans for interim analyses with intent to stop the 
registry early or to adapt the registry design or planned number 
of patients. 
Determination, if 
DSMB required 
There will not be a DSMB utilized for this observational registry. 

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1. 
Patient parameters, as listed in Section 19.1 Data Elements, subsection 2. 
2. 
Liver tissue assessments, if available, including steatosis, fibrosis/ cirrhosis, liver stiffness, vascular invasion, 
micro satellite instability 
3. 
If applicable: BCLC staging 
4. 
If applicable: Child-Pugh Score 
5. 
If applicable, per site SOC: Coagulation tests, including INR, PT, and APTT (or PTT). 
6. 
If applicable, per site SOC: Liver function tests, including AST, ALT, GGT, albumin, direct and total bilirubin, 
and total protein. 
7. 
If applicable, per site SOC: Renal function tests, including BUN, creatinine and electrolytes (sodium, potassium, 
chloride and bicarbonate). 
8. 
If applicable, per site SOC: Complete blood count test, including differential cell count and platelet count. 
9. 
If applicable, per site SOC: genetic markers include Alpha-fetoprotein (AFP), Carbohydrate antigen 19-9 (CA19- 
9), Carcinoembryonic antigen (CEA) 
10. Record all relevant prior medications taken within 60 days prior to Visit 2 and all relevant concomitant 
medications taken throughout the registry. Relevant concomitant medications include: chemotherapy, 
immunotherapy, blood-thinning or coagulation, NSAIDs, those medications used to treat AEs, those used for 
hepatitis (if concurrently treating), and any others that are relevant in the opinion of the investigator. For post- 
ablation follow-up visits, relevant concomitant medications may be assessed over the phone, as needed. 
11. Quality of Life questionnaires: EORTC QLQ-C30 and liver-specific QLQ-HCC18. The questionnaires may be 
administered over the phone, as needed. 
12. Pain score, using the Numeric Pain Rating Scale. The questionnaire may be administered over the phone, as 
needed. 
13. Use SOC imaging for all study visits. 
14. Ablation procedure details, as listed in Section 19.1 of the protocol. 
15. Healthcare provider parameters, as listed in Section 19.1 of the protocol. 
16. SOC imaging as used at every follow-up visit to determine if there is local or regional recurrence of lesion(s). If 
there is a recurrence, determine soft tissue lesion details,via CT, MRI, PET, US, and/or X-ray. Scans will be 
submitted to the Sponsor (refer to NOTE 1). 
17. Record only relevant concomitant procedures (i.e. liver or lesion-related). For post-ablation follow-up visits, 
relevant concomitant procedures may be assessed over the phone, as needed. 
18. Technical success, defined as ablation of the target lesion(s) according to the protocol and covered completely, 
with an adequate margin, as defined by the physician performing the ablation (that is, the ablation zone 
completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT, MRI, PET, 
US, and/or X-ray, immediately following the procedure. If patient has had any lesions ablated with NeuWave in 
the post-ablation follow-up visit period, assess Technical success following each ablation. 
19. Technique efficacy, defined as ablation of the target lesion(s) according to the protocol and covered completely, 
with an adequate margin, as defined by the physician performing the ablation (that is, the ablation zone 
completely overlaps or encompasses the target lesion plus an ablative margin), as assessed by CT, MRI, PET, 
US, and/or X-ray, at Visit 3. 
20. Economic impact data (as available), including the following: length of hospital stay, if applicable; number and 
types of probes used; and, ablation duration, defined as the time elapsed between first ablation probe puncture 
and removal of the last probe at the completion of the ablation. 
21. Follow-up post-ablation treatment, including the number of successful repeat ablations, if applicable, and if 
patient has been hospitalized since the procedure. If patient has been re-ablated with NeuWave, record ablation 
procedure parameters as outlined in section 19.1, subsection 1. Record date of registry completion, when 
applicable. 
22. When applicable, the Screening Visit may occur on the same day as the ablation procedure (Visit 2). 
23. Record reason for unscheduled visit, as well as AEs (if applicable), and any updates to the relevant concomitant 
medications and relevant concomitant procedures. 
24. Quality of Life and Pain Questionnaires may be administered up to 72 hours prior to the ablation procedure (Day 
0). 
25. Post-ablation Pain Score must be administered on the day of ablation (Day 0). 
26. For Visit 1 through Visit 3, Eastern Cooperative Oncology Group classification (ECOG) performance status is 
required. After Visit 3, evaluate ECOG, if applicable per site SOC. ECOG may be assessed over the phone. 

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NOTE 1: All SOC scans of the abdomen/liver, including CT, MRI, and/or PET, taken at the following timepoints 
(Screening, Ablation Day, and throughout the 5-year follow-up period) should be submitted to the Sponsor 
through 
. SOC Ultrasound scans of the abdomen/liver should also be submitted to the 
Sponsor, when on the Ablation Day or at any re-ablation visits. A subset of scans will be reviewed by the 
Central Review Committee to reduce the variability between investigators in assessing scans and to minimize 
potential bias. 
NOTE 2: Patients rolling into this registry from a previous NeuWave trial will only have data collected in the 
Registry database starting from the time they consent to participate in the registry. Any data previously 
collected on roll-over patients will remain in the original database in which it was entered into. 

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5.0 
BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE 
 
Real World Evidence can provide information on how factors such as clinical setting, health care 
provider, and health-system characteristics influence treatment effects and outcomes. Importantly, 
the use of such evidence has the potential to allow researchers to answer these questions efficiently, 
while yielding answers relevant to broader populations of patients. Prospective registries with 
planned external controls and high-quality data collection have been accepted for regulatory 
purposes in the evaluation of medical devices.¹ Ideally, patient registries collect data in a 
comprehensive manner and, therefore, produce outcome results that may be generalizable to a wide 
range of patients.² 
For the NEUWAVE Microwave Ablation System, the microwave ablation procedure parameters 
(including time, power, number and type of probes used) necessary to obtain desired short-term and 
long-term results across a range of target lesion characteristics (including size, location, co- 
morbidities, previous treatments, etc.) have not been studied in a systematic manner, nor is it known 
how operator factors affect results. 
 
 
6.0 
REGISTRY OBJECTIVES AND ENDPOINTS 
6.1 Primary Objective 
The primary objective of this registry is to compile data that will be analyzed at various 
timepoints, to understand the impact of selected parameters on procedure and patient 
outcomes. The database will capture data related to (1) Ablation Procedure parameters, (2) 
Patient parameters, and (3) Healthcare Provider parameters. 
6.2 Primary Endpoints 
The primary endpoints of this registry are below, based on different points in time: 
Perioperative endpoint- 
1. Technical success, defined as ablation of the target lesion(s) according to the protocol and 
covered completely, with an adequate margin, as defined by the performing physician (i.e. 
the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative 
margin), as assessed by CT, MRI, PET, US, and/or X-ray, immediately following the 
procedure. 
Short term endpoint- 
2. Technique efficacy, ablation of the target lesion(s) according to the protocol and covered 
completely, with an adequate margin, as defined by the performing physician (i.e., the 
ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative 
margin), as assessed by CT, MRI, PET, US, and/or X-ray, at Visit 3 (between 7 days and 
less than 3 months post-ablation). 

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Long term endpoint- 
3. Target lesion recurrence (local recurrence) rate evaluated at every visit after ablation of the 
target lesion(s), and overall evaluation at the 5-year follow-up, as assessed by CT, MRI, 
PET, US, and/or X-ray. 
6.3 Secondary Endpoints 
The secondary endpoints of this registry are: 
1. Secondary efficacy rate, defined as the percentage of soft tissue lesions that have 
undergone successful repeat ablations (target or non-target) following identification of local 
soft tissue lesion progression. A successful repeat ablation will be defined as ablation of 
the lesion according to the protocol and covered completely, with an adequate margin, as 
defined by the performing physician (i.e. the ablation zone completely overlaps or 
encompasses the lesion plus an ablative margin), as assessed by CT, MRI, PET, US, 
and/or X-ray, immediately following the procedure. 
2. Regional recurrence rate at a separate location in the liver (outside the initial treatment 
site(s)), evaluated at every visit after ablation of the target lesion(s), and overall evaluation 
at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray. 
3. Recurrence-free survival, evaluated at every visit after ablation of the target lesion(s), and 
overall evaluation at the 5-year follow-up, as assessed by CT, MRI, PET, US, and/or X-ray. 
4. Overall survival, evaluated at every visit after ablation of the target lesion(s), and overall 
evaluation at the 5-year follow-up. 
5. Assess economic impact of ablation by capturing procedure-related items such as: 
complete procedure duration, ablation duration, number of ablations, length of hospital stay, 
and number and types of probes used. 
6. Incidence of adverse events (AEs) (SAEs) that are deemed at least unlikely related to the 
procedure or device and all serious adverse events (SAEs) from the start of the ablation 
procedure through the end of the study. 
7. Two QOL questionnaires: European Organization for Research and Treatment of Cancer 
(EORTC) QLQ-C30 and liver-specific QLQ-HCC18. 
Note: These two questionnaires were chosen as tools to assess overall health status/quality 
of life in the patient population with soft-tissue liver lesions. 
8. Numeric Pain Rating Score. 

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7.0 
REGISTRY DESIGN 
7.1 Overall Registry Design and Plan – Description 
This is a multicenter, observational registry that follows patients for a total of 5 years from the 
date of the first liver ablation procedure with the NEUWAVE Microwave Ablation System. The 
data gathered from participating sites will be available to be analyzed to develop ablation 
parameter guidance for ablation approaches under varying patient liver tissue conditions and 
liver lesions. 
This is an “umbrella registry,” which was included as an optional component in other 
NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other 
NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other 
patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, 
longitudinal follow up, or enrolled retrospectively with all retrospective follow up. 
7.2 Enrollment 
The goal is to create a registry with enrollment ongoing until there are an adequate number of 
patients with which a statistically sound analysis could be performed. Enrollment for this study 
will include at least 1,500 patients throughout the world who underwent or are undergoing 
microwave ablation of one or more soft tissue liver lesions using the NEUWAVE Microwave 
Ablation System or the NEUWAVE Microwave Ablation System with Ablation Confirmation. 
7.3 Inclusion Criteria 
1. Patients who underwent or are scheduled to undergo a microwave ablation of one or 
more liver lesions with the NEUWAVE Microwave Ablation System per the device’s 
Instructions for Use (IFU). 
2. Patients with signed informed consent (or waiver approved by IRB/EC) who are willing 
to comply with the assessment schedule, and willing to have data included in the 
database. 
3. Patients > 22 years old at the time of informed consent (or waiver approved by 
IRB/EC). 
7.4 Exclusion Criteria 
1. Patients with a life expectancy of less than 1 year, in the opinion of the treating 
physician. 
2. Use of microwave ablation purely as a transection tool, rather than focused liver lesion 
ablation. 

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3. Patient is currently participating, or planning to participate, in another 
NeuWave/Ethicon-funded clinical trial or registry studying microwave ablation in the 
liver. Note: roll-over patients from previous NeuWave trials are permitted. 
7.5 Prior and Concomitant Therapy 
Patients may continue with their current medical care throughout the duration of the registry, 
including medications. Relevant concomitant medications will be recorded on the relevant eCRF 
page. Relevant concomitant medications include: chemotherapy, immunotherapy, blood- 
thinning or coagulation, NSAIDs, those medications used to treat AEs, those used for hepatitis 
(if concurrently treating), and any others that are relevant in the opinion of the investigator. 
7.6 Screen Failures 
All patients signing consent who do not meet the eligibility or who do not have the ablation 
procedure initiated will be recorded as screen failures. The relevant eCRF pages (i.e. 
demographics and reason for screen failure) will be completed for all screen failure patients and 
thereby included in the registry database. 
7.7 Removal of Patients from the Registry 
In accordance with the current revision of the Declaration of Helsinki and the Code of Federal 
Regulations, a patient has the right to withdraw from the registry at any time for any reason 
without prejudice to his/her future medical care by the physician or the institution. Should a 
patient (or patient’s legally authorized guardian/representative) decide to withdraw from the 
registry, all efforts will be made to collect all AEs the patient may have experienced. 
Participation may be terminated prior to completing the registry for any of the reasons listed 
below (reasons that do not fit the categories below will be documented as “other”). 
Withdrawal of Consent: 
If a patient chooses to withdraw early from the registry, the patient should contact the site, which 
will then complete the Subject Completion/Discontinuation eCRF page. When a patient’s 
participation is terminated prior to completing the registry, the reason for withdrawal is to be 
documented on the eCRF and in the source documentation. 
Investigator Decision for Patient Termination: 
The Investigator may withdraw a patient for any safety reason, including, but not limited to, the 
following reasons: 
1. Inability of Investigator to locate and target the soft tissue liver lesion. 
2. Inability of patient to tolerate the anesthesia. 
 
Note: If a patient experiences an AE during probe puncture and is not ablated, this patient 
should be followed until AE resolution. If no AE occurred during probe puncture and the 
patient could not be ablated, the patient should be discontinued. 

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Death: 
When available, the cause of death should be documented in the AE eCRF. The Subject 
Completion/Discontinuation eCRF also must be completed. 
Lost to follow-up: 
All patients should be encouraged to return for clinic visits for evaluation during the registry 
follow-up period. After all attempts to contact the patient have failed and after 2 consecutive 
missed visits to the site, a patient will be considered lost to follow up. Should the patient return 
to the site, their status in the database may be updated accordingly and data continue to be 
collected. For patients who are definitively lost to follow-up, the reason for early termination will 
be completed in the Subject Completion/Discontinuation eCRF. 
Site Termination or Registry Termination: 
The Sponsor may terminate a site or the registry at any time. When this occurs all patients at 
the site will be withdrawn and documented as “early termination.” Reasons for site or registry 
termination may include, but are not limited, to the following: 
1. Administrative concerns (e.g., inadequate patient enrollment, investigator/institution non- 
compliance, change of business strategy, etc.). 
2. Safety issues including those due to non-compliance, which substantially affect the risk- 
to-benefit ratio of the registry patients at a site or for the registry as a whole. 
3. Regulatory body mandates. 
 
8.0 
REGISTRY POPULATION 
The registry population includes patients with one or more soft tissue liver lesions of any size, 
location, or shape who underwent or will undergo a MWA procedure with the NEUWAVE 
Microwave Ablation System. 
9.0 
INVESTIGATOR RESPONSIBILITIES 
9.1 Good Clinical Practices 
An Investigator is responsible for ensuring that this registry is conducted in accordance with 
the ethical principles that have their origin in the Declaration of Helsinki and that are consistent 
with the ICH GCP, the signed Clinical Trial Agreement, this Protocol, the institution’s IRB/EC 
policies and procedures, and applicable regulatory requirements. 
Prior to the initiation of this clinical registry at each site, the responsible Principal Investigator 
will approve this Protocol by signing the signature page. This signature confirms that the clinical 
registry will be performed in compliance with this protocol. 
The following documents must be provided to the Sponsor prior to registry start: 
1. 
A copy of the formal written notification to the Investigator regarding approval of the 
protocol by an IRB/EC that is in compliance with regulatory guidelines. 

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2. 
A copy of the IRB/EC approved ICF or ICF waiver and other adjunctive materials (e.g., 
advertising) to be used in the registry, including written documentation of IRB/EC 
approval of these items. 
3. 
Name and address of the IRB/EC, and a current list of the IRB/EC members. If 
accompanied by a letter of explanation from the IRB/EC, a general statement may be 
substituted for this list, or a general assurance number. 
4. 
Applicable local regulatory documentation. 
5. 
Signed and dated protocol Investigator Signature page. 
6. 
Signed confidentiality agreement between the Investigator and the Sponsor. 
7. 
Signed and dated clinical trial agreement, including financial agreement. 
8. 
Up-to-date signed and dated curriculum vitae for each investigator and sub- 
investigator. 
9. 
Statement of Investigator. 
Other documents may also be required prior to the registry and during the course of the registry. 
 
 
9.2 Institutional Review Board/Ethics Committee 
Participating investigators will ensure that this protocol, corresponding ICF/Waiver, or protocol 
amendments, and if applicable, any other written information provided to the patients that assist 
in the decision to participate are reviewed by an IRB/EC that complies with governmental 
requirements. The approving IRB/EC will be responsible for the initial and continuing review 
and approval of this registry. Participating investigators will be required to promptly report to 
the IRB/EC as required by the IRB’s/EC’s policies. Additionally, investigators will be required 
to refrain from making any changes in the protocol without Sponsor and IRB/EC approval of an 
amended protocol, except where necessary to eliminate apparent immediate hazards to 
registry patients or others. 
9.3 Patient Information and Consent 
To minimize selection bias, sites should attempt to identify and approach all eligible patients 
for consent who were ablated or will be ablated for soft tissue liver lesions using the NEUWAVE 
Microwave Ablation System or the NEUWAVE Microwave Ablation System with Ablation 
Confirmation. Patients who had liver ablations with NEUWAVE prior to consent are eligible to 
participate as retrospectively enrolled patients. Retrospective patients can be fully 
retrospective (all protocol visits have occurred prior to the date of ICF/waiver) or can have some 
prospective follow-up (applicable protocol visits occur after signing the ICF). 
The informed consent process involves the investigator or delegated staff to complete the 
following activities: giving a patient adequate information concerning the registry, providing 
adequate time for the patient to consider all available options, responding to the patient’s 
questions, ensuring that the patient has comprehended this information, and finally, prior to a 

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patient’s participation in this registry, an ICF will be signed and dated by the patient and person 
who conducted the consent discussion. All prospective patients in this registry should be 
completely informed about the purpose, risks, benefits, and other pertinent details of this 
registry. The informed consent process is careful to avoid the perception of any coercion or 
undue influence on, or inducement of, the patient to participate, and does not waive or appear 
to waive the patient’s legal rights. The ICF is presented in native, non-technical language that 
is understandable to the patient. The patient will be provided with a copy of the signed ICF. 
Completely retrospective patients will need to have an ICF waiver in place prior to having his 
or her data collected. 
The ICF and any other written materials provided to the patient to assist in the decision to 
participate must be revised whenever new information becomes available that may be relevant 
to their willingness to participate or continue participation in this registry. Revision to the ICF 
and other written materials will receive IRB/EC approval before implementation. Each patient 
required to sign an amended ICF will receive a copy of the signed ICF. All original signed 
amended ICFs will also be kept within the patient’s medical record. 
 
 
10.0 
REGISTRY INTERVENTIONS 
There is no intervention, beyond necessary, standard, clinical care in this registry. 
 
 
11.0 
REGISTRY PROCEDURES AND EVALUATIONS 
11.1 Procedure Description(s) 
Pseudoanonymized data from all patients who provide consent (or an IRB approved ICF 
waiver), and who are undergoing or have undergone microwave ablation of one or more soft 
tissue liver lesions using the NEUWAVE Microwave Ablation System will be included in the 
registry’s clinical database. The ablation will be performed in accordance with the institution’s 
SOC for microwave ablation and per the device’s IFU. 
11.2 System Overview 
The NEUWAVE Microwave Ablation System has a single 2.45 GHz signal microwave source 
generator and three (3) independent microwave amplifiers, each capable of producing up to 
140W each. Generator power is limited based upon the number of probes selected and the 
types of probes used. One touch-screen user interface controls the system. The User Interface 
can be set for either Ablation Mode or Surgical Mode. Up to three (3) microwave ablation 
probes can be connected to and powered by the system at one time. An intermediate junction 
box or Power Distribution Module (PDM) reduces system set up complexity. 
Cooling System Overview 

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A CO2 based cooling system ensures the non-active portion of the probe does not exceed 
temperature requirements. Additionally, the CO2 enables the Tissu-Loc™ function, which may 
be used to adhere or stick the probe in place prior to starting ablation therapy. This function is 
similar in use to the stick function available on cryogenic ablation systems. 
The system uses two (2) CO2 cylinders (size may vary by market). When a tank in use empties, 
the system will automatically switch to using the other tank and notify the user to replace the 
empty tank. 
The cooling system regulates the flow of high-pressure CO2 in a cooling gas tube to the PDM 
and eventually to the probe. Inside the tip of the probe, the cooling gas tube expands from high 
pressure to low pressure. As the gas pressure reduces quickly, the Joule-Thompson effect 
causes the probe shaft to cool. This is used for both the Tissu-Loc™ function and to keep 
probes at a safe temperature while energy is being delivered to the patient. 
The PDM is designed to improve the usability of the system by reducing set-up complexity 
while also helping to minimize the cabling from the probe to the generator. The PDM also allows 
a larger, lower-loss cable to be used between the microwave generator and PDM. The 
increased efficiency of the larger cable and PDM allow more power to be safely sent to the 
ablation probe without an unsafe heating of the probe cable or handle. 
System performance is constantly monitored. The NEUWAVE Microwave Ablation System will 
automatically discontinue delivering microwave energy in the event of system failures. 
NEUWAVE Ablation Probes Overview 
NEUWAVE Ablation Probes are provided sterile and are intended for single patient use only. 
Ablation probes are comprised of a sharp trocar on the end of a cannula, a probe handle, a 
1.4-meter cable, and a connector assembly. 
Each NEUWAVE Ablation probe contains three (3) temperature measurement sensors that 
help monitor performance and ensure patient and operator safety. 
The NEUWAVE ablation probe assembly contains four (4) main sections: a handle, a cannula, 
a radiating section, and a faceted tip for insertion. 
All NEUWAVE Ablation Probes should be used within their cleared indications. 
Most commonly used probes are LK and PR. NEUWAVE LK probes are designed to perform 
optimally, in terms of efficiently transferring energy into tissue, in liver and kidney tissues. 
The antenna of the NEUWAVE PR probe is designed to limit the length of the ablation 
compared to LK probes for instances when a shorter ablation zone is desired. The 
NEUWAVE PR probes are designed to produce ablations that quickly encompass the tip of the 
probe while limiting the overall length of the ablation. NEUWAVE PR probes will enable 
physicians to ablate smaller lesions while limiting necrosis of adjacent tissue when compared 
with other NEUWAVE probes. 
Refer to the NEUWAVE Microwave Ablation System accompanying documents, such as the 
IFU, for a list of Warnings and Cautions. 

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11.3 Central Review Committee 
An independent, Central Review Committee (CRC) will be used to reduce the variability between 
investigators in assessing scans and to minimize potential bias. The CRC will assess a subset 
of scans for prospectively-enrolled patients at each site. The CRC will review these scans and 
provide assessments including, but not limited to, lesion details at baseline, outcome of ablation, 
and lesion recurrence/progression during the post-ablation period. 
As this is a SOC registry, assessments by the Principal Investigator (PI) will be used for all 
treatment decisions, as well as all protocol-defined analyses. Review by the CRC will be 
compared, where applicable, to the assessments made by the PI. The results of these 
comparisons will be summarized in separate analyses as part of the Clinical Study Report (CSR) 
and/or publication(s). 
 
 
12.0 
REGISTRY SCHEDULE 
The Schedule of Assessments, which is found at the end of the Protocol Summary, serves as 
a guideline for participating sites regarding data to be collected for this registry. All should 
closely reflect standard of care. 
12.1 Visit 1 – Screening 
The screening assessments for this visit may occur over several dates within 60 days prior to 
Visit 2. If the patient is not seen within a 60 day window of the Ablation Day (Visit 2), the 
Screening Visit may occur on the same day as the ablation procedure. 
Patients will be selected for microwave ablation based on the pre-procedure investigations and 
the Investigator’s opinion. Eligible patients will be provided with the registry information, 
including the ICF. 
The following screening assessments will occur within 60 days prior to the ablation visit (Visit 
2): 
• 
Patients must be given ample time to review and sign the ICF, or have a waiver in place, 
where applicable. 
• 
Collect demographic information (age at time of Visit 1, sex, race, ethnicity). 
• 
Collect patient parameters, as outlined in Section 19.1, subsection 2. 
• 
Perform a liver tissue assessment (if available): steatosis (mild, moderate, severe); 
fibrosis/cirrhosis (mild, moderate, severe; include pathology results and fibrosis stage, 
if known); liver stiffness (actual stiffness value in kilopascals, if known); vascular 
invasion (presence or absence); microsatellite instability (MSI; high [MSI-H], low [MSI- 
L], or microsatellite stable [MSS]). 
• 
BCLC staging, if applicable 

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• 
Evaluate Eastern Cooperative Oncology Group classification (ECOG) performance 
status. 
• 
Body Mass Index (BMI): height and weight. 
• 
Child-Pugh Score, if applicable and American Society of Anesthesiologists (ASA) 
Score. 
• 
SOC imaging used to determine the ablation plans (CT, MRI, PET, Ultrasound (US), 
and/or X-ray), even if not within the screening window, should be used to determine 
soft tissue liver lesion details (e.g., lesion size, lesion type, location, shape). 
o If a Screening Visit occurs and the patient’s SOC scans do not fall within the 
screening window, then an additional scan is not required for the screening visit. 
o For purposes of this Registry, target lesions are defined as any lesions ablated or 
intended to be ablated on the Ablation Day (Visit 2). Non-target lesions are defined 
as any lesions not ablated or not intended to be ablated on the Ablation Day (Visit 
2). 
o All SOC scans of the abdomen/liver (CT, MRI, and/or PET) should be submitted to 
the Sponsor. 
• 
Laboratory tests if applicable, per site SOC; to be done within 60 days of the ablation 
procedure, 
 Coagulation tests, including, INR, PT and APTT (or PTT). 
 Liver function tests, including AST, ALT, GGT, albumin, direct and total 
bilirubin, and total protein. 
 Renal function tests, including BUN, creatinine and electrolytes (sodium, 
potassium, chloride and bicarbonate). 
 Complete blood count (CBC), including differential cell count and platelet count. 
 Genetic markers including: Alpha-fetoprotein (AFP) level, Carbohydrate 
antigen 19-9 (CA19-9) level, Carcinoembryonic antigen (CEA). 
• 
Review inclusion and exclusion criteria. 
• 
Record all relevant medications taken within 60 days prior to Visit 2: Relevant 
concomitant medications include: chemotherapy, immunotherapy, blood-thinning or 
coagulation, NSAIDs, those used for hepatitis (if concurrently treating), and any others 
that are relevant in the opinion of the investigator. 
12.2 Visit 2 – Ablation Procedure 
Patients will be under anesthesia during the procedure per the site’s SOC. On the day of 
ablation, SOC imaging will be done at the timepoints listed in the section below. 
Pre-ablation 
Data collected before the procedure: 
• 
Evaluate ECOG performance status (prior to ablation). 

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• 
Confirm that the patient still meets inclusion and exclusion criteria. 
• 
Record all relevant concomitant medications: Relevant concomitant medications 
include: chemotherapy, immunotherapy, blood-thinning or coagulation, NSAIDs, those 
used for hepatitis (if concurrently treating), and any others that are relevant in the 
opinion of the investigator. 
• 
QOL questionnaires, using EORTC QLQ-C30 and liver-specific QLQ-HCC18. The 
questionnaires may be administered up to 72 hours prior to the ablation procedure. The 
questionnaires may also be administered over the phone, as needed. 
• 
Pain score, using the Numeric Pain Rating Scale. The questionnaire may be 
administered up to 72 hours prior to the ablation procedure. The questionnaire may also 
be administered over the phone, as needed. 
• 
SOC imaging (i.e. CT, MRI, US) to determine soft tissue liver lesion details (e.g. size, 
location, shape, stage), if performed as part of site’s routine SOC. 
 
During ablation 
Use SOC imaging to guide the microwave ablation probe to the target soft tissue liver lesion(s) 
and insert the probe into the lesion(s). Data collected during the procedure: 
• 
Record ablation procedure details as outlined in section 19.1, subsection 1 
• 
Record any applicable AEs/SAEs. 
 
Note: When available, some of the above ablation procedure details will be provided to the site 
via a report generated from the Call Home Database. The site will review the Call Home report 
and enter the procedure details into the clinical database, as applicable. 
 
Post-ablation 
After the ablation procedure, the following assessments will occur: 
• 
Pain score using the Numeric Pain Rating Scale. The post-ablation pain score must be 
administered on the day of ablation (Day 0). The questionnaire may be administered 
over the phone, as needed. 
• 
Relevant concomitant procedures (i.e. liver or lesion-related). 
• 
Record all applicable AEs/SAEs and product complaints. 
• 
Imaging to evaluate technical success, defined as ablation of the target lesion(s) 
according to the protocol and covered completely, with an adequate margin, as defined 
by the physician performing the ablation (that is, the ablation zone completely overlaps 
or encompasses the target lesion plus an ablative margin), as assessed by CT, MRI, 
PET, US, and/or X-ray, immediately following the procedure. 
• 
Length of hospital stay, measured from post-ablation to discharge. 
• 
Record Healthcare provider parameters as outlined in section 19.1, subsection 3 
• 
Record any remaining ablation procedure details 

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• 
Record all relevant concomitant medications: Relevant concomitant medications 
include: chemotherapy, immunotherapy, blood-thinning or coagulation, NSAIDs, those 
medications used to treat AEs, those used for hepatitis (if concurrently treating), and 
any others that are relevant in the opinion of the investigator. 
 
Note: All SOC scans of the abdomen/liver on the day of ablation (CT, MRI, PET, and/or US) 
should be submitted to the Sponsor. 
12.3 Post-ablation Follow-up Visits 
The list of assessments is the same for all follow-up visits unless otherwise specified. 
At each follow-up visit, the patient will visit the site (or have a tele-visit and/or phone visit when 
unable to visit the site) and the following assessments will occur: 
• 
Evaluate ECOG performance status (Visit 3 only). After Visit 3, evaluate ECOG, if 
applicable per site SOC. ECOG may be assessed over the phone. 
• 
Laboratory tests, as follows, if applicable per site SOC: 
 
Coagulation tests, including, INR, PT and APTT (or PTT). 
 
Liver function tests, including AST, ALT, GGT, albumin, direct and total 
bilirubin, and total protein. 
 
Renal function tests, including BUN, creatinine and electrolytes (sodium, 
potassium, chloride and bicarbonate). 
 
CBC, including differential cell count and platelet count. 
 
Genetic markers including: Alpha-fetoprotein (AFP) level, Carbohydrate 
antigen 19-9 (CA19-9) level, Carcinoembryonic antigen (CEA). 
• 
Record all relevant concomitant medications: Relevant concomitant medications 
include: chemotherapy, immunotherapy, blood-thinning or coagulation, NSAIDs, those 
medications used to treat AEs, those used for hepatitis (if concurrently treating), and 
any others that are relevant in the opinion of the investigator. Relevant concomitant 
medications may be assessed over the phone. 
• 
QOL questionnaires, using EORTC QLQ-C30 and liver-specific QLQ-HCC18, (Visits 3 
through 6). The questionnaires may be administered over the phone, as needed. 
• 
Pain score using the Numeric Pain Rating Scale (Visit 3 only). The questionnaire may 
be administered over the phone, as needed. 
• 
Technique efficacy evaluation (Visit 3 only). 
• 
Imaging to determine whether there has been a local or regional recurrence of lesion(s). 
If there is a recurrence, determine soft tissue liver lesion details via CT, MRI, PET, US, 
and/or X-ray. 
o All SOC scans of the abdomen/liver (CT, MRI, and/or PET) should be submitted 
to the Sponsor. 
• 
Record relevant concomitant procedures (i.e. liver or lesion-related). Relevant 
concomitant procedures may be assessed over the phone. 

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• 
Record follow-up post-ablation treatment, including the number of successful repeat 
ablations, if applicable, and if patient has been hospitalized since the procedure. If 
patient has been re-ablated with NeuWave, record ablation procedure details as 
outlined in section 19.1, subsection 1. 
• 
Record all applicable AEs/SAEs and product complaints. Assessments for safety may 
be assessed over the phone. 
• 
Record date of registry completion, when applicable. 
 
Note: in the case a patient has a liver resection or liver transplant, he/she should continue to be 
followed in the study, as outlined per the study protocol. Post-ablation follow-up visits should occur 
as per site SOC. 
 
 
 
12.4 Unscheduled Visits 
The following data will be collected during each unscheduled visit: 
• 
Reason for the unscheduled visit. 
• 
AEs/SAEs, if applicable. 
• 
If applicable, SOC imaging to determine whether there has been a local or regional 
recurrence of lesion(s). If there is a recurrence, determine soft tissue liver lesion details 
via CT, MRI, PET, US, and/or X-ray. 
o All SOC scans of the abdomen/liver (CT, MRI, and/or PET) should be submitted 
to the Sponsor. 
• 
Any follow-up post-ablation treatment, including the number of successful repeat 
ablations, if applicable, and if patient has been hospitalized since the procedure. If patient 
has been re-ablated with NeuWave, record ablation procedure parameters as outlined in 
section 19.1, subsection 1 and product complaints, as applicable. Upload of SOC images 
on the day of re-ablation with NeuWave should follow the requirements of upload per Visit 
2 – Ablation Procedure. 
 
• 
Any updates to the relevant concomitant medications and relevant concomitant 
procedures 
 
 
13.0 
ASSESSMENT OF SAFETY 
Patients will be assessed and monitored for all AEs that are deemed at least unlikely related to the 
procedure or device from the day of ablation (from the time of first probe insertion) through the 5- 
year follow-up visit and all SAEs. 

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13.1 Adverse Events 
Definitions 
Adverse Event 
For this registry, an adverse event is defined as any undesirable clinical occurrence (sign, 
symptom, or disease) in a patient. Only AEs that are deemed at least unlikely-related to the 
procedure or device will be collected. All SAEs, regardless of relationship to the study device 
or procedure, will be collected. 
Expected Morbidity / Anticipated Adverse Events 
An expected morbidity/procedural complication is defined as an AE that is known to be common 
or usual in nature, severity, or incidence during ablation of the liver. 
Serious Adverse Event 
All SAEs, regardless of relationship to the study device or procedure will be collected. It is the 
Investigator’s responsibility to determine the “seriousness” of an AE using the protocol defined 
terms, listed below. An SAE is an AE that results in one or more of the following for this registry: 
• Resulted in death: An AE that resulted in the patient’s death. 
• Life-threatening illness or injury: The patient was at imminent risk of dying at the time 
of the adverse event. 
• Permanent impairment: An AE that resulted in permanent impairment of a body function 
or permanent damage to a body structure. 
• Required in-patient or prolonged hospitalization. 
• Resulted in medical or surgical intervention to prevent life threatening illness or injury 
or permanent impairment to a body or body function. 
• Led to fetal distress, fetal death or congenital abnormality or birth defects. 
Notes: 
1. Progression of the disease under study should not be reported as an SAE. 
2. “Death” should not be reported as an AE. The cause of death should be reported as 
an AE. The only exception is “Sudden Death” when the cause is unknown. 
3. Planned hospitalization for a pre-existing condition is not considered an SAE. 
 
SEVERITY OF ADVERSE EVENTS 
It is the Investigator’s responsibility to assess the severity of an AE. A change in severity may 
constitute a new reportable AE. 
Also, the following guideline should be used to determine the severity of each adverse event: 

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• MILD: Awareness of signs or symptoms, but does not interfere with the patient’s usual 
activity or is a transient event that resolves without treatment and with no sequelae. 
• MODERATE: A sign or symptom, which interferes with the patient’s usual activity. 
• SEVERE: Incapacity with inability to do work or usual activities. 
 
RELATIONSHIP OF ADVERSE EVENTS 
It is the Investigator’s responsibility to assess the relationship between all AEs to the registry 
device and procedure. All SAEs, regardless of relationship to the study device or procedure 
will be collected. Adverse events deemed to have an unlikely, possible, probable, or causal 
relationship to the procedure or device should be captured in source as part of the study and 
entered in the the AE eCRF. Adverse events deemed to be not related to the procedure or 
device should only be captured in source. The following guidelines should be used in 
determining the relationship of an AE to a device, procedure, or other causality: 
 
Not related 
Relationship to the procedures or device can be excluded when: 
• 
The event is not a known side effect of the product category 
the device belongs to or of similar device and procedures; 
• 
The event has no temporal relationship with the use of the 
device or the procedures; 
• 
The event does not follow a known response pattern to the 
device (if the response pattern is previously known) and is 
biologically implausible; 
• 
The discontinuation of the device application or the reduction 
of the level activation/exposure (when clinically feasible) and 
reintroduction of its use (or increase of the level of 
activation/exposure), does not impact on the event; 
• 
The event involves a body-site or an organ not expected to 
be affected by the device or the procedure; 
• 
The 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); 
• 
Harms to the subject are not clearly due to use error; or 
• 
To establish the non-relatedness, not all the criteria listed 
above might be met at the same time, depending on the type 
of device/procedure and the 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. 

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Possible* 
The relationship with the use of the device is weak but cannot be 
ruled out completely. Alternative causes are also possible (e.g. an 
underlying or concurrent illness/condition and/or an effect of 
another device, drug, or treatment). Cases where relatedness 
cannot be assessed, or no information has been obtained should 
also be classified as possible. 
Probable* 
The relationship with the use of the device seems relevant and/or 
the event cannot reasonably be explained by another cause, but 
additional information may be obtained. 
Causal 
Relationship* 
The event is associated with the device or with procedures 
beyond reasonable doubt when: 
• 
The event is a known side effect of the product category the 
device belongs to or of similar device and procedure 
• 
The event has a temporal relationship with the device 
uses/application or procedures 
• 
The event involves a body-site or organ that 
o The device or procedures are applied to 
o The device or procedures have an effect on 
• 
The event follows a known response pattern to the medical 
device (if the response pattern is previously known) 
• 
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 event (when clinically 
feasible) 
• 
Other possible causes (e.g. an underlying or concurrent 
illness/clinical condition and/or an effect of another device, 
drug, or treatment) have been adequately ruled out 
• 
Harm to the subject is due to error in use 
• 
To establish the relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of 
device/procedure and the event. 
*Denotes “related” to the procedure or device and should be captured (AE) as part of the study. 

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13.2 Reporting Adverse Events 
All procedure-related and device-related AEs (non-serious) and all SAEs from the time of the 
first probe placement through study completion (Visit 14), or to the time of early withdrawal of 
the study, must be reported in the AE eCRF. The Investigator will evaluate the severity of the 
event and its relatedness to the registry device or procedure. 
The Investigator is required to report all applicable non-serious AEs to the Sponsor within 2 
weeks of becoming aware of the adverse event(s). All SAEs are to be reported as soon as 
possible, but no later than 72 hours after becoming aware of the event, regardless of relationship 
to the device or study procedure. 
The study site will report applicable AEs and all SAEs to the Sponsor by entering the event into 
the EDC system via the Adverse Event eCRF, which will trigger an automated email to the 
Sponsor. Additional information, including the Investigator’s assessment, may be added to the 
eCRF later. Any necessary medical management of the event will be recorded in the patient’s 
medical record/source document. If the Sponsor requires supporting documentation or other 
information, the Sponsor will contact the study site. 
Data related to AEs and SAEs will be collected until event resolution, until the event is 
considered stable, or until all attempts to determine the resolution of the event are exhausted. 
All AEs and SAEs that are unresolved at study completion (or early termination) will be recorded 
as ongoing at study end. 
In addition, the following information should be recorded: 
• 
Onset date 
• 
Resolution date or date of death 
• 
Action taken 
• 
Event status (ongoing at registry end or resolved) 
• 
Relationship of AE to the ablation device used in the registry 
• 
Relationship of AE to the registry procedure 
• 
Indication of seriousness. 
• 
Was AE anticipated or not (only for serious, device-related AEs) 
The report of an AE or SAE by a site does not constitute an admission that registry personnel 
or the user facility (hospital/clinic) caused or contributed to the event. The site is responsible 
for submitting AEs to the reviewing IRB/EC, per their IRB/EC procedures. 
For retrospectively enrolled patients, the site should review patient medical records (i.e. 
through chart review) to look for reportable AEs/SAEs. Collection of AE data and reporting 
requirements will be the same for retrospective events, however, Sponsor reporting timelines 
do not apply. 

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13.3 Product Complaints 
Product Complaint Definition 
A product complaint is defined as any written, electronic, or oral communication that alleges 
deficiencies related to the identity, labeling, quality, durability, reliability, safety, effectiveness, 
or performance of a device after it is released for distribution (21CFR 820.3 (b)). A product 
complaint may or may not be associated with an AE/SAE. 
Product complaints may include, but are not limited to: 
• 
Product contamination; 
• 
Defective components; 
• 
Poor packaging or product mix-up; 
• 
Device malfunction (the failure of a device to perform as intended for this registry); 
• 
Labeling concerns; 
• 
User errors. 
 
Reporting Product Complaints 
All product complaints related to devices in the procedure shall be documented throughout the 
registry study. 
The registry site must report product complaints related to a device manufactured by NeuWave 
Medical, Inc., in a timely manner after becoming aware of the event. When any representative 
of the Sponsor becomes aware of a product complaint, the Sponsor representative must notify 
the Sponsor’s Product Complaint Team with the least practical delay after becoming aware of 
the event through a Product Complaint Form to the following email address 
(Productcomplaint1@its.jnj.com) or by calling 1-877-ETHICON, Option 5. 
One copy of the processed form should be kept on-site, and the device should be retained. 
Sponsor representatives will organize collection of the device for evaluation, as needed. 
 
 
14.0 
DEVIATIONS FROM THE CLINICAL REGISTRY PLAN 
A protocol deviation is any noncompliance with the registry protocol, Good Clinical Practice, or 
protocol-specific requirements. A deviation (any activity conducted outside the parameters 
established by the registry protocol) can be identified from a number of sources. Potential 
sources include but are not limited to: a member of the Investigator’s staff, a Sponsor 
representative during monitoring visits, or a member of the data management or statistical 
groups when entering or analyzing data. Regardless of the source, it is crucial to document the 
deviation in the protocol deviation eCRF. The Investigator will report protocol deviations to the 
IRB/EC as required by the IRB/EC procedures. 

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Any deviation from the protocol or procedures should be recorded in the source documents. 
Assessments or visits that are not completed because they are not SOC at a site, or 
assessments that were not completed for retrospective patients, should not be considered 
protocol deviations. 
Steps to be taken to assure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate sites, the review of protocol procedures with the Investigator and 
associated personnel prior to the registry, and periodic monitoring visits by the Sponsor. The 
Sponsor will review eCRFs for accuracy and completeness during monitoring visits; any 
discrepancies will be resolved with the Investigator or designees, as appropriate. 
 
 
15.0 
REGISTRY PRODUCT 
All NEUWAVE Microwave Ablation Systems, the NEUWAVE Microwave Ablation System with 
Ablation Confirmation, and the NEUWAVE Ablation Probes used in the registry are legally 
marketed in the countries where they are used. The registry products should be used within 
their cleared indications as per the Instructions For Use. 
 
 
16.0 
CLINICAL MONITORING 
This registry will be monitored by the Sponsor to ensure the following: 
• 
The rights and well-being of the patients are protected. 
• 
Reported registry data is accurate, complete, and verifiable from source documents. 
• 
The conduct of the registry is in compliance with the currently approved 
protocol/amendment(s), applicable GCPs, and with applicable local regulatory 
requirements. 
Steps to be taken to assure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate sites, review of protocol procedures with the Investigator and 
associated personnel prior to the registry, and periodic monitoring visits by the Sponsor. The 
Sponsor will review eCRFs for accuracy and completeness during monitoring visits; any 
discrepancies will be resolved with the Investigator or designees, as appropriate. 
The extent and nature of monitoring will be predetermined and based on considerations such 
as the objective, design, complexity, and endpoints of the registry and mutually agreed to by 
the Sponsor and investigators. Monitors will comply with established written standard operating 
procedures as well as procedures (i.e., monitoring plan) specified by the Sponsor for monitoring 
this registry. These monitoring procedures are characterized in the Monitoring Plan for this 
registry. 

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17.0 
STATISTICAL METHODOLOGY 
17.1 Statistical and Analytical Plans 
The Sponsor Data Management and Biostatistics groups will be responsible for the analysis of 
data from this protocol. A comprehensive and detailed Statistical Analysis Plan (SAP) to 
supplement the statistical design and analysis described in this section will be finalized prior to 
the first analysis of data from this protocol. 
Categorical variables will be summarized descriptively by frequencies and associated 
percentages. Continuous variables will be summarized descriptively by number of patients, 
mean, standard deviation, median, minimum, and maximum. Confidence intervals will also be 
provided for procedure-related variables. 
17.2 Registry Design 
This is a multicenter, observational registry that follows patients for a total of up to 5 years from 
the date of the first liver ablation procedure with either the NEUWAVE Microwave Ablation 
System or the NEUWAVE Microwave Ablation System with Ablation Confirmation. 
This is an “umbrella registry,” which was included as an optional component in other 
NEUWAVE studies; hence, data from consenting patients who are or will be enrolled in other 
NEUWAVE soft tissue liver lesion ablation studies will be included in this registry. All other 
patients will be enrolled and followed prospectively, enrolled retrospectively with prospective, 
longitudinal follow up, or enrolled retrospectively with all retrospective follow up. 
17.3 Treatment Assignment 
This is a single-arm registry where all enrolled patients will be ablated using the NEUWAVE 
Microwave Ablation System as part of the site’s SOC treatment or per protocol for those 
patients who are also enrolled in other NEUWAVE studies. 
17.4 Interval Windows 
Interval windows are provided in the Schedule of Assessments, which appears at the end of 
the Protocol Summary. No additional windows are planned for analysis purposes. 
17.5 Primary Endpoint and Associated Hypotheses 
This protocol does not have a single primary endpoint and there are no associated hypotheses. 
Rather, there are several patient-level outcomes of interest that will be investigated through 
statistical modeling to estimate the relationship between these outcomes and various patient, 
provider, and ablation-specific parameters. These patient-level outcomes of interest include: 
technical success, technique efficacy, secondary efficacy rate, target lesion recurrence rate, 
recurrence-free survival, and overall survival. 

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17.6 Levels of Significance 
No levels of significance are specified as no specific hypotheses about any of the outcomes of 
interest are being formulated or tested. Significance levels relating to variable selection in a 
statistical regression model will be specified in the SAP. 
17.7 Analysis Sets 
All patients contributing data to the registry will be considered eligible for inclusion into planned 
analyses. Specific rules regarding a minimum or critical number of observed dependent and 
independent variables for inclusion into statistical modeling analyses will be specified in the 
SAP. 
17.8 Sample Size Justification 
This registry will be open to receiving data from all patients who are ablated with microwave 
ablation of soft tissue liver lesions using the NEUWAVE Microwave Ablation System. Given 
that the objective of the registry is to investigate the relationships that exist between the stated 
clinical outcomes, patient and provider parameters, and microwave ablation (MWA) time and 
power, no power analysis or sample size determination have been performed given the 
absence of a specific hypothesis to test. Rather, a statistical modeling exercise will occur at 
pre-specified intervals after sufficient data has been entered to support exploratory statistical 
modeling. The timing of these analyses will be defined in the SAP. Additional ad-hoc analyses 
will be conducted throughout the duration of the registry. 
17.9 Analyses to be Conducted 
Categorical variables will be summarized descriptively by frequencies and associated 
percentages. Continuous variables will be summarized descriptively by number of patients, 
mean, standard deviation, median, minimum, and maximum. Confidence intervals will also be 
provided for procedure-related variables. 
Disposition of Registry Patients 
Patient disposition will be summarized using counts and percentages. The number and 
percentage of patients completed and discontinued along with the specific reasons for 
discontinuation will be tabulated. 
Demographic and Baseline Characteristics 
Summary statistics will be provided for patient demographics and pre-operative ablation 
characteristics. 
Primary and Secondary Endpoint Analyses 
Regression analysis methodologies will be utilized to explore the relationship between 
dichotomous clinical outcomes (technical success, technique efficacy, and secondary efficacy 
rate) and ablation procedure, patient, and provider parameters. Time to event analyses will be 
used for target lesion recurrence, regional recurrence rate, recurrence-free survival, 
progression free survival, and overall survival. 

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Complete details regarding all analysis methodologies including approaches to handle multiple 
lesions per patient, variable selection techniques, data reduction techniques given the number 
of potential independent variables, as well as subgroup analyses of interest will be specified in 
the SAP. 
The number and percentage of patients achieving technical success will be summarized and a 
95% confidence interval will be provided. A similar summary will be provided for technique 
efficacy, as well as for the primary and secondary efficacy rates, as previously defined. 
Target lesion recurrence rates at each post-ablation scheduled visit will be estimated using the 
Kaplan-Meier method and 95% confidence intervals will be provided. A similar summary will 
be provided for the 5-year overall rate. Similar summaries will also be provided for regional 
recurrence rate, overall and progression-free survival rates for the entire observation period 
from the ablation procedure date through 5 years of follow-up. 
Scores from the EORTC QOL questionnaires and Numeric Pain Rating Scales will be 
summarized with methodology consistent to the recommendations of the specific survey. 
Additional endpoints will be summarized with descriptive statistics. 
Plans for Interim Analysis 
There are no plans for interim analyses with an intent to stop the registry early or to adapt the 
registry design or planned number of patients. 
Analysis of Safety 
From start of ablation procedure through the 5-year follow-up visit, procedure and device- 
related AEs, and all SAEs will be collected, and these will be summarized by system organ 
class and preferred term. Ninety-five percent confidence intervals may be provided for pre- 
specified adverse events of interest, which are: 
• Ascites (accumulation of fluid causing abdominal swelling) 
• Biloma/bile leak (buildup of bile within the abdomen)/bile leak) 
• Bile duct injury 
• Bleeding requiring transfusion, embolization (obstructing of blood vessel or organ to 
stop bleeding), or prolonged hospital stay 
• Intrahepatic hematoma 
• Pneumothorax and hemothorax 
• Organ injury other than the liver (such as gastrointestinal injury/perforation, 
diaphragmatic injuries/hernia) 
• Fever 
• General feeling of tiredness 
• Infection 

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• Liver dysfunction. 
• Liver abscess 
• Nausea 
• Pain 
• Pneumonia 
• Pleural effusion 
• Post ablation syndrome, which is your body’s response to the destroyed lesion. You 
may experience flu-like symptoms, including fever, decreased appetite, and general 
discomfort. This syndrome generally happens 3 to 5 days after the ablation 
procedure. 
• Skin burn 
• Thrombosis (local coagulation or clotting of the blood in the circulatory system, 
with/without tube drainage) 
• Tumor implantation 
 
 
Handling of Dropouts or Missing Data 
Given that this is a registry that will include both retrospective and prospective data, with some 
patients coming from other NeuWave clinical trials, missing data is expected for both the 
dependent and independent variables in the regression analyses described above. Specific 
rules regarding imputation of missing data (e.g. multiple imputation, minimum number of 
observed variables, sensitivity analyses) will be provided in the SAP. 
Multicenter Studies 
Analyses will be adjusted for center through the inclusion of the various provider-specific 
variables described above. 
Analysis of Subgroups 
Subgroup analyses will be performed for levels of the following variables: Location of lesion 
(near vessel >3mm, Dome, Subcapsular, Segment); Underlying disease (mild, moderate or 
severe cirrhosis; presence of fatty liver; post chemotherapy); Type of disease (CRLM, 
HCC, Cholangiocarcinoma, Other); ASA score; Child-Pugh score; Type of hospital; 
Experience of the ablationist; AC vs no AC; and gender. Additional subgroups of interest may 
be identified pending the distribution of various parameters at enrollment. Details regarding the 
analysis methodologies for these subgroups will be pre-specified in the SAP. 

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18.0 
ETHICS/PROTECTION OF HUMAN PATIENTS 
18.1 Institutional Review Board/Ethics Committee 
Participating investigators must obtain IRB or EC approval prior to execution of the protocol. 
Only IRBs/ECs that comply with governmental requirements may approve this registry. 
Prospective investigators must provide to an IRB/EC this protocol, ICF and/or waiver, , and if 
applicable, any protocol amendments or other written information provided to the patients. This 
includes information to be completed by participants or the Investigator and staff, such as 
survey instruments or questionnaires, and any proposed advertising or recruitment materials. 
The approving IRB/EC will be responsible for the initial and continuing review and approval of 
this clinical registry. The participating investigators will be required to promptly report to the 
IRB/EC as required by the IRB/EC’s policies. Additionally, investigators will be required to 
refrain from making any changes in the clinical registry plan without Sponsor and IRB/EC 
approval of an amended protocol, except where necessary to eliminate apparent immediate 
hazards to registry patients or others. 
18.2 Applicable Regulations 
This registry will be conducted in compliance with Good Clinical Practice and in accordance 
with the Declaration of Helsinki, as well as any other applicable local and country regulatory 
requirements. 
18.3 Patient Information and Consent 
Regulations concerning the protection of patients require that informed consent be obtained, 
or waiver approved by the IRB/EC where applicable, before a patient may participate in any 
clinical registry. For this registry, a patient must be consented or waiver approved by the 
IRB/EC before completing any registry specific procedures. Screening information that are part 
of SOC procedures may occur and be collected prior to consent, but the data may not be 
collected for registry purposes until the informed consent form (ICF) has been signed by the 
patient or waiver from the IRB/EC is received. A patient who signs the consent, or waiver is 
received, is considered enrolled. 
An IRB/EC approved informed consent or waiver, where applicable, must be sought from each 
patient and must be appropriately documented in the patient’s medical record. It is the 
Investigator’s responsibility to obtain written informed consent from prospective patients or 
retrospectives patients with prospective follow-up prior to registry-specific procedures.The 
Investigator may delegate this responsibility, if appropriately documented. 
19.0 
DATA HANDLING AND RECORD KEEPING 
19.1 Data Elements 
The following three categories of data will be captured in the registry database: (1) ablation 
procedure parameters, (2) patient parameters, and (3) healthcare provider parameters. The 
complete list of data parameters requested for this registry database are listed below. 

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1. 
Ablation procedure parameters: 
a) 
Procedure type: laparoscopic surgical; open surgical; percutaneous. 
b) 
Complete procedure duration from start of anesthesia administration (start time) to 
completion of the procedure (end time). 
c) 
Ablation duration for each individual ablation attempt (minutes and seconds). 
d) 
Ablation duration, defined as the time elapsed between first ablation probe puncture 
and removal of the last probe at the completion of the ablation. 
e) 
Type of anesthesia used during ablation procedure. 
f) 
Anatomical location of ablation. 
g) 
Liver stiffness near ablation site, if obtained prior by ultrasound or MRI. 
h) 
Smallest ablation margin, if available. Note: if less than 5mm margin, include reason 
(vessel, duct, location, bowel, other). 
i) 
Ablation Zone measurement, if available 
j) 
Use of hydrodissection during ablation procedure. 
k) 
Type of probe(s) (including serial number). 
l) 
Number of probes. 
m) Maximum probe temperature, per probe (°C). 
n) 
Power settings used per probe (Watts). 
o) 
Constant power vs ramp-up. 
p) 
Number of probe placement attempts per probe (to get the probe in position). 
q) 
Number of changes in probe placement throughout the ablation (after energy has 
been delivered). 
r) 
Location of probe placement relative to the target lesion (central, peripheral). 
s) 
Tract ablation (yes/no). 
t) 
If overlap of coagulation zones, provide overlap, if available. 
u) 
Needle navigation/placement guidance method used. 
v) 
Image fusion details, if applicable 
w) Identify if ablation procedure guidance software was used (i.e. for target identification, 
ablation monitoring, and/or ablation confirmation) 
• 
If NeuWave ablation confirmation software used, note use of the software, 
tissue contraction percentage, and the software version 
• 
If other software, note supplier/manufacturer 
x) 
If applicable, total number of CT and Xray scans used for the Ablation and total 
amount of radiation dose 
y) 
Imaging details (contrast, slice thickness if applicable). 
 
2. 
Patient parameters: 
a) 
Patient lesion details at baseline: 

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i. Type/origin of lesion: HCC, CRLM, CC, recurrent lesion (can be local recurrent or 
other intrahepatic recurrence), or metastatic lesion, if biopsy is performed. 
ii. Lesion size (measured in at least two dimensions), shape, and location (by liver 
segment). 
iii. Date of diagnosis of soft tissue liver lesion. 
iv. Lesion characteristics: stellate or smooth. 
v. Proximity to vasculature (specify name and distance to vasculature, if possible). 
vi. Proximity to other critical structures (specify, such as, bowel, stomach, skin, bile 
ducts, other). 
vii. Location of lesion: Superficial, exophytic, deep. 
i. 
Exophytic: lesion extends beyond the contour of the liver 
ii. 
Superficial: lesion that is within 10 mm of the capsule 
iii. 
Deep: lesion that is deeper than 10 mm of the capsule 
viii. Modality used for lesion measurements (CT, MRI, PET, US, and/or X-ray) 
b) 
Patient medical, surgical, and radiation histories 
i. Relevant medical history, in the opinion of the investigator 
ii. Pre-treatment embolization or other chemotherapy. 
iii. Relevant surgical history (any abdominal surgery or that is related to the soft- 
tissue lesion(s)). 
iv. Radiation history. 
v. Thermal ablation history. 
vi. Biliary manipulation history. 
vii. Other treatments for liver lesions. 
c) 
Family and genetic histories, as per SOC: 
i. CRLM family history. 
ii. HCC family history. 
iii. Any other known genetic and molecular diagnostics available. 
d) 
Abuse and exposure histories, if available: 
i. Alcohol history. 
ii. Asbestos history. 
iii. Hepatitis: B virus (HBV) / C virus (HCV), others and DNA level. 
iv. Smoking history; tobacco, marijuana, other. 
 
3. 
Healthcare provider parameters: 
a) Type of provider performing the ablation: abdominal imaging specialist, 
gastroenterologist, general surgeon, hepatologist, HPB surgeon, interventional 
radiologist, medical oncologist, surgical oncologist, ultrasonographer, other. 

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19.2 Source Documents 
Source documents are documents on which information regarding patients is first recorded, 
including printed, optical, or electronic documents. Investigator patient files or hospital records, 
generally, are the basis of source document information. This includes, but is not limited to, 
original patient files; certified copies of patient records; hospital/clinic records; original 
recordings /tracing; digital images from automated instruments (e.g., cameras); radiographs; 
photographic negatives; and records kept at the site, at the laboratories and at other 
departments involved in the clinical registry. 
Another type of source document is data from NeuWave Medical’s Call Home Database. 
NEUWAVE Microwave Ablation System has a functionality that electronically collects 
procedure data and information during the ablation procedure and is transmitted by the 
NEUWAVE Microwave Ablation System to NeuWave Medical, after the conclusion of each 
ablation procedure; this information is collectively called the “Call Home Database.” The 
procedure data includes, but not limited to, the following: date and time of procedure, 
anatomical location of ablations, number of ablations and power used for each ablation, type 
of probes used, and duration of procedure. Some of these relevant ablation procedure details 
will be provided to the site via a report generated from Call Home Database, if possible. The 
site will review the report and enter the procedure details into the registry’s clinical database. 
Reports generated from the Call Home Database must be retained by the Investigator as part 
of the patient’s permanent medical record. The report should be retained for review by the 
monitor. If a site is unable to receive the report generated from the Call Home Database, the 
relevant ablation procedure details should be manually recorded in the source documents from 
what is displayed on the NeuWave System monitor screen. 
Source documents must be retained by the Investigator as part of the patient’s permanent 
medical record. The information in the source documents is used to complete the eCRFs. All 
information captured on the eCRFs should be completely and accurately supported in source 
documentation. Any additional information relevant to the registry should be included in the 
source documents. In particular, any deviations from the registry protocol or procedures should 
be recorded in the source documents. The Investigator will retain originals of all source 
documents, patient consent form, and registry data. 

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19.7 Data Privacy 
The collection, use, and disclosure of all personal data, including patient health and medical 
information, are to be maintained in compliance with applicable personal data protection and 
security laws and regulations that govern protected health information and the informed 
consent given by each registry patient. When collecting and processing such personal data, 
appropriate measures are to be taken to maintain the confidentiality of patient health and 
medical information and to prevent access by unauthorized persons. 
 
 
20.0 
REGISTRY SUSPENSION OR TERMINATION 
The Sponsor may suspend or terminate the registry or one or more sites at any time. When this 
occurs, all patients at the site will be withdrawn and documented as early termination. Reasons 
for site or registry termination may include, but are not limited, to the following: 
• 
Administrative concerns (e.g., inadequate patient enrollment, investigator/institution 
non-compliance, change of business strategy, etc.). 
• 
Regulatory body mandates. 
The Investigator also has the right to terminate participation in the registry at any time (e.g., for 
safety or inability to enroll patients). Should termination of a site be necessary, the Sponsor will 
provide procedures for termination. 
 
 
21.0 
DATA AND PUBLICATION POLICIES 
Publication of the results of this registry will be governed by Johnson & Johnson publication 
policies, including current and applicable Medical Device Publication Policy. Any presentation, 
abstract, or manuscript will be made available for review by the Sponsor prior to submission. 
Licensing agreements or copyrights applying to tools, work products or intellectual property used 
during the registry should be observed and clearly displayed on registry documentation and 
publications, wherever appropriate. 
All manuscripts of data obtained from this clinical registry will be reviewed and approved by the 
Sponsor and each author prior to any submission. All authors must disclose financial or personal 
affiliations that could be considered a conflict of interest. 

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22.0 
SUPPLEMENTS 
 
22.1 Numeric Pain Rating Scale 
 
The Numeric Pain Rating Scale (NPRS) can be administered verbally (therefore also by 
telephone) or graphically for self-completion. As mentioned above, the respondent is asked to 
indicate the numeric value on the segmented scale that best describes their pain intensity. 
 

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22.2 Glossary 
 
 
Acronyms/ 
Abbreviations 
Terms 
2D 
2-Dimensional 
AE 
Adverse Event 
APTT 
Activated Partial Thromboplastin Time 
ASA 
American Society of Anesthesiologists 
BMI 
Body Mass Index 
CBC 
Complete Blood Count 
CC 
Cholangiocarcinoma 
CFR 
Code of Federal Regulations 
CRLM 
Colorectal Liver Metastases 
CT 
Computed Tomography 
DSMB 
Data Safety Monitoring Board 
EC 
Ethics Committee 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EORTC 
European Organization for Research and Treatment of Cancer 
EOS 
End of Study 
FeNo 
Fractional Exhaled Nitric Oxide 
GCP 
Good Clinical Practices 
GGT 
Gamma-Glutamyl Transpeptidase 
HCC 
Hepatocellular Carcinoma 
ICF 
Informed Consent Form 
IFU 
Instructions for Use 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
LOS 
Length of Hospital Stay 
MRCSI 
Member of the Royal College of Surgeons (Ireland) 
NPRS 
Numeric Pain Rating Scale 

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Acronyms/ 
Abbreviations 
Terms 
NSAIDs 
Non-Steroidal Anti-Inflammatory Drugs 
PAP 
Positive Airway Pressure 
PDM 
Power Distribution Module 
PET 
Positron Emission Tomography 
PI 
Principal Investigator 
PT 
Partial Prothrombin 
PTT 
Partial Prothrombin Time 
QOL 
Quality of Life 
SAE 
Serious Adverse Event 
SOC 
Standard-of-Care 
USV 
Unscheduled (visit) 

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23.0 
DOCUMENT FILING 
A copy of all approved versions of the Registry Protocol will be kept by the site, in the Investigator 
Site File and in the Sponsor Trial Master File. 

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24.0 
SCIENTIFIC REFERENCES 
 
1. Sherman R, Anderson S, Dal Pan G,et al. Real-World Evidence — What Is It and 
What Can It Tell Us? NEJM 375;23 December 8, 2016. 
2. Gliklich R, Dreyer N, Leavy M, eds. Registries for Evaluating Patient Outcomes: A 
User’s Guide. Third edition. Two volumes. (Prepared by the Outcome DEcIDE Center 
[Outcome Sciences, Inc., a Quintiles Company] Agency for Healthcare Research and 
Quality. April 2014. 
 
3. Aarson NK, Ahmedzai S, Bergman B, et al. The European Organization for Research 
and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international 
clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. 
 
4. Chie WC, Blazeby JM, Hsiao CF, et al. International cross-cultural field validation of an 
European Organization for Research and Treatment of Cancer questionnaire module 
for patients with primary liver cancer, the European Organization for Research and 
Treatment of Cancer quality-of-life questionnaire HCC18. Hepatology. 2012 Apr;55(4): 
1122-9. Epub 2012 Mar 1. 
5. Hjermstad MJ, Fayers PM, Haugen DF, et al. Studies Comparing Numerical Rating 
Scales,Verbal Rating Scales, and Visual Analogue Scales for Assessment of Pain 
Intensity in Adults: A Systematic Literature Review. Journal of Pain and Symptom 
Management 2011 June, 41(6)1073-1093.