A Single-Arm, Prospective, Multicenter Study to Evaluate the Effectiveness and Safety of the NeuWave Certus Microwave Ablation System in Chinese Patients With Primary or Secondary Tumors in the Lung
Phase: NA
Conditions: Cancer of the Lung
Sponsor: Ethicon, Inc.

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NEU_2020_02
A Single-Arm, Prospective, Multicenter Study to Evaluate the 
Effectiveness and Safety of the NeuWave Certus Microwave 
Ablation System in Chinese Patients with Primary or 
Secondary Tumors in the Lung 
Name of Investigational 
Medical Device
NeuWave Certus Microwave Ablation System and Accessories
Model Specification
See Appendix
Management Category of 
Investigational Medical Device
Class III medical device requiring clinical trial approval
Predicate Product in China Yes
No
Protocol Version Number
V2.0
Protocol Version Date
September 15, 2021
Clinical Trial Leading 
Institution
Beijing Hospital
Leading Investigator
Dr. Li, Xiaoguang
Sponsor
NeuWave Medical, Inc.
Agent
Johnson & Johnson Medical (Shanghai) Ltd.
This study protocol contains the confidential information for the use of clinical investigators only. This document 
remains the exclusive property of the Johnson & Johnson Medical. The undisclosed information herein should not be 
disclosed without the prior written approval of Johnson & Johnson Medical.

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Protocol Approval Form
Protocol Number:
NEU_2020_02
Protocol Title:
A Single-Arm, Prospective, Multicenter Study to Evaluate the 
Effectiveness and Safety of the NeuWave Certus Microwave 
Ablation System in Chinese Patients with Primary or Secondary 
Tumors in the Lung
Protocol Date:
September 15, 2021
Name
Signature
Date
Author
Qian, Yingjun
Approvals:
Title
Name
Signature
Date
Senor Director
Clinical Franchise Platform Lead
Patricia 
Schleckser
Senior Franchise Medical Director
Biosurgery and NeuWave
Richard
Kocharian
Clinical Research Director
Johnson & Johnson Medical 
(Shanghai) Ltd.
Liu, Fenghua
Medical Affairs Department Head
Johnson & Johnson Medical 
(Shanghai) Ltd.
Li, Vivian
BU Regulatory Affairs Lead
Johnson & Johnson Medical 
(Shanghai) Ltd.
Gu, Yi
Associate Director
Data Management and Biostatistics
Michael Schwiers
COMPLIANCE STATEMENT
This study will be conducted in compliance with the Declaration of Helsinki as well as all applicable 
local regulations.

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TABLE OF CONTENTS
LIST OF ABBREVIATIONS ............................................................................................................................ 6
SYNOPSIS............................................................................................................................................................ 8
1. 
SPONSOR INFORMATION ......................................................................................................... 22
2. 
LIST OF ALL THE CLINICAL TESTING FACILITIES AND INVESTIGATORS 
PARTICIPATING IN THE CLINICAL TRIAL .......................................................................................... 23
3. 
OBJECTIVE AND CONTENTS OF CLINICAL TRIAL ........................................................ 23
3.1. OBJECTIVE OF CLINICAL TRIAL.........................................................................................................................23
3.2. CONTENTS OF CLINICAL TRIAL ......................................................................................................................... 23
4. 
BACKGROUND INFORMATION OF CLINICAL TRIAL .................................................... 24
4.1. INTRODUCTION TO THE CONDITION .................................................................................................................. 24
4.1.1. Explanation for the Condition ..................................................................................... 24
4.1.2. Selection of Diagnosis and Treatment Method and Disease Prognosis ....................... 25 
4.2. APPLICATION OF INVESTIGATIONAL PRODUCT ................................................................................................ 26
4.3. PRODUCT REGISTRATION PROFILE AND REASON FOR CONDUCTING THE REGISTRATION CLINICAL 
TRIAL IN CHINA ............................................................................................................................................................ 27
5. 
FEATURES, STRUCTURAL COMPOSITION, OPERATION PRINCIPLE, 
MECHANISM OF ACTION, AND STUDY POPULATION ..................................................................... 27
5.1. 
FEATURES ........................................................................................................................................................ 27
5.1.1. 
Design Features of Investigational Product ........................................................... 27 
5.1.2. 
Material Features of Investigational Product ........................................................ 28 
5.2. 
STRUCTURAL COMPOSITION, OPERATION PRINCIPLE, MECHANISM OF ACTION ................................ 28
5.2.1. 
Composition of Investigational Product ................................................................ 29
5.2.2. 
Operation Principle and Mechanism of Action of Investigational Product ........... 30 
5.3. 
STUDY POPULATION ...................................................................................................................................... 31
6. 
PRODUCT INDICATIONS AND CONTRAINDICATIONS, PRECAUTIONS .................. 31
7. 
OVERALL DESIGN ....................................................................................................................... 32
7.1. TRIAL DESIGN ....................................................................................................................................................... 32
7.1.1. Trial Objective ............................................................................................................. 32
7.1.2. Trial Method Selection and Its Rationale .................................................................... 32 
7.1.3. Measures to Reduce and Avoid Bias ........................................................................... 33 
7.1.4. Investigational Medical Device ................................................................................... 33 
7.1.5. Selection of Subjects: .................................................................................................. 34
7.1.6. Efficacy Evaluation Method ........................................................................................ 38

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7.1.7. Exploratory Parameters Evaluation Method ............................................................... 40
7.1.8. Safety Evaluation Method ........................................................................................... 41 
7.2. TRIAL FLOW .......................................................................................................................................................... 42
7.2.1. Trial Flow Chart .......................................................................................................... 42
7.2.2. Specification for Device Use....................................................................................... 42
7.2.3. Study Procedure .......................................................................................................... 44
7.3. MONITORING PLAN..............................................................................................................................................53
8. 
STATISTICAL CONSIDERATIONS ........................................................................................... 54
8.1. STATISTICAL DESIGN, METHOD AND ANALYSIS PROCEDURE ....................................................................... 54
8.2. CALCULATION OF SAMPLE SIZE.........................................................................................................................57
8.2.1. Total Sample Size ........................................................................................................ 57
8.2.2. Number of Clinical Trials Subjects for Each Disease and Reasons for Determination
............................................................................................................................................... 57
8.2.3. Significance Level and Power of Clinical Trial .......................................................... 58
8.2.4. Expected Dropout Rate ............................................................................................... 58
8.3. ACCEPTANCE/NONACCEPTANCE CRITERIA OF CLINICAL TRIAL RESULTS ................................................. 58
8.4. CRITERIA AND REASON FOR TERMINATING THE TRIAL BASED ON THE STATISTICAL RESULTS .............. 58
8.5. STATISTICAL METHOD OF ALL DATA, TOGETHER WITH THE HANDLING METHOD OF MISSING, UNUSED 
AND ERROR DATA (INCLUDING TERMINATION AND WITHDRAWAL HALFWAY) AND UNREASONABLE DATA
 ........................................................................................................................................................................................ 58
8.6. PROCEDURES FOR REPORTING DEVIATIONS FROM THE ORIGINAL STATISTICAL PLAN ............................ 59
8.7. SELECTION CRITERIA AND RATIONALE FOR SUBJECTS INCLUDED IN THE ANALYSIS ............................... 59
8.7.1. Full Analysis Set ......................................................................................................... 59 
8.7.2. Per-Protocol Set .......................................................................................................... 59 
8.7.3. Safety Set .................................................................................................................... 59 
9. 
DATA MANAGEMENT ................................................................................................................. 59
10.
FEASIBILITY ANALYSIS ............................................................................................................ 60
10.1. ANALYSIS ON THE POSSIBILITY OF SUCCESS ................................................................................................. 60
10.2. FEASIBILITY ANALYSIS OF FAILURE ................................................................................................................ 60
11. 
QUALITY CONTROL OF CLINICAL TRIAL ......................................................................... 61
12.
ETHICAL ISSUES AND INFORMED CONSENT OF CLINICAL TRIAL ........................ 61
12.1. ETHICAL CONSIDERATIONS.............................................................................................................................. 61
12.2. REVIEW AND APPROVAL OF TRIAL PROTOCOL .............................................................................................. 62
12.3. PROCESS OF INFORMED CONSENT AND TEXT OF INFORMED CONSENT FORM ........................................ 62
12.3.1. Process of Informed Consent .................................................................................... 62 
12.3.2. Text of Informed Consent Form ................................................................................ 62 
13.
DEVICE MANAGEMENT ............................................................................................................ 62

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13.1. PACKAGING AND LABELING OF STUDY DEVICE........................................................................................... 63
13.2. SHIPPING OF STUDY DEVICE............................................................................................................................63
13.3. MANAGEMENT OF STUDY DEVICE .................................................................................................................. 63
13.4. RETURN AND DESTRUCTION OF STUDY DEVICE ........................................................................................... 64
14.
REGULATIONS OF ADVERSE EVENT AND DEVICE COMPLAINT REPORTING ... 64
14.1. ADVERSE EVENTS .............................................................................................................................................. 64
14.2. SERIOUS ADVERSE EVENT ...............................................................................................................................67
14.3. DEVICE COMPLAINTS........................................................................................................................................ 68
14.4. DEVICE DEFICIENCIES ....................................................................................................................................... 68
14.5. REPORTING PROCEDURE, CONTACT PERSON INFORMATION ......................................................................68
15.
REGULATIONS ON CLINICAL TRIAL PROTOCOL DEVIATIONS AND CLINICAL 
TRIAL PROTOCOL AMENDMENT ........................................................................................................... 69
16.
DIRECT ACCESS TO SOURCE DATA AND DOCUMENTS ................................................ 70
17.
FINANCES AND INSURANCE .................................................................................................... 71
18.
CONTENTS TO BE COVERED IN THE CLINICAL TRIAL PROTOCOL ...................... 71
19.
PRINCIPLES OF CONFIDENTIALITY .................................................................................... 71
20.
CONVENTION ON PUBLICATION OF TRIAL RESULTS .................................................. 72
21.
RESPONSIBILITIES UNDERTAKEN BY DIFFERENT PARTIES ..................................... 72
21.1. RESPONSIBILITIES OF THE SPONSOR ............................................................................................................... 72
21.2. RESPONSIBILITIES OF CLINICAL TRIAL INSTITUTION AND INVESTIGATOR ............................................... 73
21.3. RESPONSIBILITIES OF OTHER INTERESTED PARTIES .................................................................................... 74
STATEMENT OF INVESTIGATOR ............................................................................................................. 75
APPENDIX 1: STUDY DEVICES CODE LIST .......................................................................................... 76
APPENDIX 2: REFERENCES ....................................................................................................................... 77
 

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LIST OF ABBREVIATIONS
Abbreviations
Description of Abbreviations
2D
Two Dimensional
3D
Three Dimensional
ALT
Alanine Aminotransferase
AST
Aspartate Aminotransferase
APTT
Activated Partial Thromboplastin Time
AE
Adverse Event
CHU
Complaint Handling Unit
CT
Computed Tomography
CRF/e-CRF
Case Report Form / Electronic Case Report Form
EC
Ethics Committee
ECOG
Eastern Cooperative Oncology Group
EDC
Electronic Data Capture
EORTC QLQ
European Organization for Research and Treatment of Cancer 
Quality of Life Questionnaire
FAS
Full Analysis Set
FDA
Food and Drug Administration
GCP
Good Clinical Practices
ICF
Informed Consent Form
IFU
Instructions for Use
INR
International Normalized Ratio
IRB
Institutional Review Board
IRC
Independent Review Committee
ITT
Intention to Treat
MW
Microwave
NSAID
Nonsteroidal Anti-inflammatory Drug
NMPA
National Medical Products Administration
NPRS
Numeric Pain Rating Scale
NSCLC
Non-Small Cell Lung Cancer
OS
Overall Survival
PP
Per Protocol
PI
Principle Investigator
PDM
Power Distribution Module
PLT
Platelet Count
PT
Prothrombin Time
QOL
Quality of Life Questionnaire
RF
Radiofrequency

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SAE
Serious Adverse Event
SAP
Statistical Analysis Plan
SIR
Society of Interventional Radiology
SCLC
Small Cell Lung Cancer
SOC
Standard of Care
SOP
Standard Operation Procedure
US
United States
USV
Unscheduled Visit

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SYNOPSIS
Study Title
A Single-Arm, Prospective, Multicenter Study to Evaluate 
the Effectiveness and Safety of the NeuWave Certus 
Microwave Ablation System in Chinese Patients with 
Primary or Secondary Tumors in the Lung 
Protocol No.
NEU_2020_02
Sponsor
NeuWave Medical, Inc. 
Study Objectives
To evaluate the effectiveness and safety of the NeuWave 
Certus Microwave Ablation System and Accessories in the 
percutaneous microwave ablation of primary or secondary 
lung tumor.
Study Devices
NeuWave Certus Microwave Ablation System and Probes
Study Design
This study is a single-arm, prospective, multicenter clinical 
trial with a performance goal (PG).
The study population includes patients with non-small cell 
lung cancer (NSCLC) or oligometastatic lung tumor who plan 
to receive percutaneous microwave ablation. Individuals who 
have lung tumor(s) meeting the eligibility criteria of the study 
and sign the Informed Consent Form will be enrolled into this
study.
Each enrolled patient will have his or her eligible lung 
tumor(s) ablated using the NeuWave Certus Microwave 
Ablation System (in conjunction with the NeuWave Certus 
Microwave Ablation Probes) in a single surgery. Subjects
will be followed at 1, 3, 6, and 12 months after the initial 
microwave ablation procedure to evaluate the effectiveness 
and safety of percutaneous microwave ablation with the study 
device.

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To provide study sites with an opportunity to get equal 
experience in the use of the Certus system, each study site 
will have 2 subjects treated as part of a run-in phase. These 
subjects will only be included in the safety analysis set.
Sample Size
N=120 plus run in subjects (each site will enroll 2 run-in 
subjects)
Study Population
Adult patients with NSCLC or oligometastatic lung tumor(s)
Study Duration
Enrollment:
Approximately 18 months
Follow-Up: 
1 year
Procedures
Description
All the NSCLC and oligometastatic lung tumor microwave 
ablation procedures of this study will be performed 
percutaneously by doctors who are experienced in lung tumor 
ablation in the study site using the NeuWave Certus Ablation 
System (in conjunction with NeuWave Certus Microwave 
Ablation Probes). During the ablation, subjects will be under 
anesthesia as per the institution’s standard of care (SOC). CT 
scan will be used to guide the probe to the tumor, confirm 
accurate placement of the probe prior to emitting the 
microwaves and confirm final ablation zone.
Primary Endpoint and 
Follow-up Interval
Technical Efficacy Rate: Percentage of tumors that are 
completely covered by the ablation zone with no sign of 
pathological enhancement according to the lung contract-
enhanced CT assessment at Visit 3 (30 days ± 7 days after the 
initial ablation procedure).
Secondary Endpoints 
and Follow-up
Interval
Secondary Effectiveness Endpoints:
Technical Success Rate: Percentage of tumors that 
achieve A0 or A1 ablation classification determinations 
(i.e., complete tumor ablation with a surrounding margin) 

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in the lung CT immediately following the initial ablation 
procedure.
A0 Ablation Rate: Percentage of tumors that achieve A0 
ablation (i.e., the ablation zone covers the tumor 
completely and has a margin of at least 5mm for 
secondary lung tumors and at least 10mm for primary 
lung tumors) in the lung CT immediately following the 
initial ablation procedure.
Re-Ablation Technical Success Rate: Percentage of 
tumors that achieve Technical Success in the lung CT 
immediately following the repeat ablation with the study 
device during the study.
Local Tumor Progression: Local tumor progression and 
time to local tumor progression of any original-ablated 
tumor(s). 
Progression-Free Survival:  Length of the time the 
patient is still alive after the original ablation procedure 
and with no evidence of any tumor progression (local, 
regional, or distant).
Overall Survival: Length of time that the patient is still 
alive after the original ablation procedure within the 
study duration.
Safety Endpoints:
All AEs from the start of any ablation procedure (from 
the probe puncture on skin) to 30 days post-ablation or 
early discontinuation .
All SAEs from the start of ablation procedure through the 
end of the study or early discontinuation.
All device-related AEs, procedure-related AEs, device-
related SAEs, procedure-related SAEs from the start of 
ablation procedure through the end of the study or early 
discontinuation.

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Exploratory Endpoints
Patient Report Outcomes:
Ablation-Procedure Related Pain: Compare the 1 day 
post-ablation, 3 day post-ablation, 1 month post-ablation 
versus pre-ablation patient-reported pain levels using the 
Numeric Pain Rating Scale.
Quality of Life: Compare the patient’s 1 month post-
ablation, 6 months post-ablation, and 12 months post-
ablation to the pre-ablation Quality of Life scores using 
EORTC QLQ-C30 and Lung-specific QLQ-LC13.
ECOG
Performance Status: Patient functionality as 
measured by distribution of Eastern Cooperative Oncology 
Group (ECOG) classification scores over time.
Ablation Procedure Related Indicators: Number and types 
of probes used, number of ablation cycles, ablation power and 
time.
Length of Hospital Stay: The duration from the patient’s 
completion of ablation procedure to discharge.
Re-Admission Rate: Percentage of unplanned hospital 
admission or re-admission due to an adverse event occurring 
within 30 days after any ablation procedure using the study 
device (i.e. the original ablation or a repeat ablation).
Inclusion Criteria
Subjects will be included if ALL of the following inclusion 
criteria are met:
1.
Signed the informed consent form and willing to 
fulfill the study-related assessments and procedure 
schedule.
2.
ineligible for/decline surgery and who plan to receive 
microwave ablation therapy.
3.
ECOG performance status score of 0-2.
4.
Patients 
with 
stages 
IA1-IA2
NSCLC 
with 

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documented results from a biopsy or patients with
clinically diagnosed oligometastatic lung tumor(s).
5.
Tumor(s) to be ablated in a single surgery should be 
a maximum of one NSCLC tumor or a maximum of 
three ipsilateral oligometastatic lung tumors. 
6.
Tumor(s) to be ablated in a single surgery should be 
2cm, locate in the outer two-thirds of a lung, not 
closer than 1cm from the hilum of lung, great vessels, 
principal bronchus, trachea or esophagus, and not 
contiguous with the pleura.
Exclusion Criteria 
Subjects will be excluded if ANY of the following 
exclusion criteria is met:
1.
Pregnant or breast-feeding.
2.
Patients with implantable pacemakers or other 
electronic implants. 
3.
Oligometastatic tumors patients whose primary 
lesion cannot be controlled or have widely 
metastases, in the opinion of the investigator and/or 
treating oncologist.
4.
Any planned concurrent procedure at the time of 
ablation.
5.
Planned treatment for other tumors in the same side 
lung during the study period.
6.
With a skin infection or ulceration at the site to be 
punctured by probe(s).
7.
Clinical or imaging findings consistent with an 
active pulmonary infection.
8.
Patients with severe pulmonary fibrosis in the area 
intended 
to 
ablate, 
especially 
drug-induced 
pulmonary fibrosis.
9.
Patients with prior radiotherapy in the area intended 

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to ablate.
10. Patients with uncontrolled malignant pleural 
effusion at the lung side with tumor to ablate.
11. Tumors where the anticipated zone of ablation 
would encompass significant (in the opinion of the 
treating physician) emphysematous or bullous 
disease.
12. The investigator anticipates that the ablation zone of 
the multiple tumor(s) to be ablated may have 
overlapping ablation zones.
13. Patients who have received lung ablation or surgical 
resection therapy within 30 days prior to the ablation 
procedure under study and those who plan to receive 
lung tumor ablation or surgical resection therapy or 
radiation therapy on the ablated lung side before 
completing 
the 
primary 
efficacy 
endpoint 
assessment approximately 30 days after the ablation 
procedure.
14. Patients who received systemic therapy such as 
chemotherapy, 
targeted 
drug 
therapy, 
or 
immunotherapy within 7 days prior to the ablation 
procedure under study, and patients who had a 
systemic treatment plan such as chemotherapy, 
targeted drug therapy, immunotherapy, etc. before 
completing 
the 
primary 
efficacy 
endpoint 
assessment approximately 30 days after the ablation 
procedure.
15. Patients with uncorrectable coagulopathy based on 
investigator judgment.
16. Patients with a platelet count
50 × 109/L.
17. Patients 
who 
cannot 
discontinue 
antiplatelet 
medication (e.g., aspirin, clopidogrel, prasugrel, 
ticagrelor) at least 5 days before the ablation 
procedure through 24 hours post-procedure.

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18. Patients who cannot discontinue anticoagulant 
medication (e.g., rivaroxaban, apixaban, dabigatran, 
edoxaban) at least 3 days before the ablation 
procedure through 24 hours post-procedure.
19. Patients who cannot discontinue warfarin before at 
least 5 days before the ablation procedure of the 
study or have an INR > 1.5. 
20. As judged by the investigator, the patient has 
hypertension that cannot be effectively controlled by 
pharmacological treatments.
21. Severe hepatic, renal, cardiac, pulmonary or cerebral 
insufficiency, severe anemia, dehydration, and 
severe nutrition and metabolism disorders, which 
cannot be corrected or improved within a short term; 
or 
serious 
systemic 
infection; 
or 
severe 
neuromuscular diseases.
22. Expected survival less than 6 months.
23. Participation in any other interventional clinical 
study within 30 days before screening.
24. Physical or psychological condition which would 
impair study participation.
25. Patient is judged unsuitable for study participation 
by the investigator for any other reason.
Intra-Ablation Exclusion Criteria:
26. Before ablation probe puncture on the skin, patient 
is judged unsuitable for study participation due to 
intolerance to anesthesia.
27. Before ablation probe puncture on the skin, patient 
is judged unsuitable for study participation due to 
presenting any other condition.
Safety Assessments
From the time of signing the informed consent form until 
approximately 30 days (Visit 3) after ablation (including 

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primary and repeat ablation) or early discontinuation, all 
adverse events will be recorded. During this period, all
adverse events from the start of ablation (i.e., probe puncture 
on the skin) will be reported.
After approximately 30 days (Visit 3) post ablation, adverse 
events considered by the investigator as related to the study 
device or/and study procedures and all serious adverse events 
will be recorded and reported till the end of the study or early 
discontinuation.
Statistical Analysis
Sample Size Calculation:
A systematic review and meta-analysis was performed and 
resulted in selecting a performance goal (PG) of 80%. A 
sample size of 120 subjects is necessary to achieve at least 
80% power for demonstrating that the Technical Efficacy rate 
of the NeuWave Certus Microwave Ablation System is > 
80% when the expected performance is 90%, and a one-sided 
significance level of 0.025 is used with the Normal 
Approximation to the Binomial distribution, with adjustment 
for 10% dropout. Each site will enroll 2 subjects first in the 
run-in phase besides the 120 subjects. In view of the lack of 
available clinical data for evaluating the performance of the 
study product in percutaneous lung tumor ablation procedure, 
the sample size will be re-estimated adopting a self-adaptive 
method after approximately 50% of the initial planned sample 
size are enrolled.
Statistical analysis of study endpoints:
The number and percentage of tumors achieving Technical 
Efficacy will be summarized and corresponding 95% 
confidence intervals will be estimated. If the lower limit of 
the 95% CI of the Technical Efficacy Rate is higher than the 
predefined PG value, primary endpoint success will be 
concluded.
The Technical Success Rate, A0 Ablation Rate, Re-Ablation 
Technical Success Rate will be summarized in a similar way. 

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The Local Tumor Progression, Progression-Free Survival, 
and Overall Survival will be calculated using the Kaplan-
Meier method, and corresponding 95% confidence intervals 
will be provided.
The number and percentage of subjects experiencing any 
adverse event (AE) and serious adverse event (SAE) will be 
summarized at the preferred term level of MedDRA. Study 
device-related AEs, ablation procedure-related AEs, device-
related SAEs, and ablation procedure-related SAEs will be 
summarized in a similar way. The incidence of specified AEs 
of interest will be summarized and reported.  
In addition, descriptive statistics of all other endpoints 
defined in the protocol will be provided.
Three analyses are planned. The first analysis will occur after 
50% of the target enrolled subjects complete the Visit 3,
aiming to inspect the assumptions used for calculation of 
sample size and determine if the sample size should be 
increased. The second analysis will occur after all enrolled 
subjects complete the 1-month visit, aiming to evaluate the 
Technical Efficacy Rate, peri-procedural endpoints, and 
safety in the period from the ablation procedure to 1 month 
post-procedure, and if the primary endpoint success is 
deemed, the study report will be submitted to the National 
Medical 
Products 
Administration 
(NMPA)
for 
the 
registration application of lung ablation indication. The third 
analysis will occur after all subjects complete the study.

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TABLE 1: SCHEDULE OF ACTIVITIES
Visit number 
Visit 1 
Visit 2A 
Visit 2B 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
USV25 
Visits 
Screening Ablation Discharge Follow-up Follow-up Follow-up 
Follow-up 
Interval Window 
Within 30 
d prior to 
ablation 
Ablation 
Day 
Post-
ablation 
30 days 
(±7 d) 
3 months 
(±14 d) 
6 months 
(±30 d) 
12 months 
(±30 d) 
Informed consent 
X 
 
 
 
 
 
 
 
Assess Inclusion / Exclusion Criteria 
X 
X1 
 
 
 
 
 
 
Collection of demographic information and 
body height, body weight 
X 
 
 
 
 
 
 
 
Blood or urine pregnancy test 2
X
Laboratory tests 3 
X 
 
 
 
 
 
 
 
Medical/surgical history/radiation history 4
X
ECOG performance status score5 
X 
 
X 
X 
X 
X
X 
 
Biopsy 
X6,7 
 
 
 
 
 
 
 
Contrast-enhanced CT of the lungs 
X8 
 
 
X9 
X9 
X9
X9 
 
Plain CT scan or X-ray of the lungs
X10
X11
 
Pre-procedure classification of lung 
tumor(s) to be ablated 12
X 
 
 
 
 
 
Pre-procedure assessment of lung tumor 13
X
X
Recording ablation procedure details 14 
 
X 
 
 
 
 
 
 
Numeric Pain Rating Scale 
 
X15 
X15 
X 
 
 
 
 
QOL Quality of Life Questionnaires 16 
X 
 
 
X 
 
X
X 
 
Length of stay 17
X
Re-admission assessment 18
X

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Visit number 
Visit 1 
Visit 2A 
Visit 2B 
Visit 3 
Visit 4 
Visit 5 
Visit 6 
USV25 
Visits 
Screening Ablation Discharge Follow-up Follow-up Follow-up 
Follow-up 
Interval Window 
Within 30 
d prior to 
ablation 
Ablation 
Day 
Post-
ablation 
30 days 
(±7 d) 
3 months 
(±14 d) 
6 months 
(±30 d) 
12 months 
(±30 d) 
Technical Success evaluation (investigator 
and IRC) 19 
 
X 
 
 
 
 
 
 
Technical Efficacy evaluation (investigator 
and IRC) 20 
 
 
 
X 
 
 
 
 
Local Tumor Progression evaluation 
(investigator and IRC) 21
 
 
 
 
X 
X
X 
 
Progression-Free Survival evaluation 21
X
X
X
X
AEs/SAEs 22 
X 
X 
X 
X 
X 
X
X 
X 
Concomitant meds23
X
X
X
X
X
X
X
X
Concomitant procedures 24 
X 
X 
X 
X 
X 
X
X 
X 
 
 
 
 
 
Notes:
1. On the day of ablation and before the ablation procedure is performed, the inclusion and exclusion criteria will be reviewed 
again to make sure all subjects continue to meet all criteria.
2. The blood or urine pregnancy test must be performed within 7 days prior to ablation (Visit 2A); otherwise the test must be 
repeated and available prior to ablation. Applicable to women of childbearing potential only.
3. All laboratory tests must be performed within 7 days prior to ablation (Visit 2A), otherwise the test(s) must be repeated 
and available prior to ablation. Laboratory tests include complete blood count (including differential count) and coagulation 
test (APTT, PT, and INR).

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4. The relevant medical/surgical/radiation history should at least include previous diagnosis of systemic tumors and 
pathological results (if any), history of other non-tumor lung diseases, history of chronic diseases, history of lung and/or 
oncologic-related mediation/surgery/procedure/radiation history and smoking status.
5. ECOG performance status score.
6. If the investigator assesses a patient’s lung tumor(s) to be ablated as primary, the patient can be enrolled only if the lesion 
to be ablated is biopsy-proven as NSCLC before the ablation.
7. The investigator should not perform concurrent biopsy on tumors during the ablation procedure. Biopsy results should be 
collected before the ablation procedure.
8. Subjects must receive at least one contrast-enhanced CT scan of the lungs in the study site within 30 days prior to ablation
(Visit 2A).
9. Lung contrast-enhanced CT scan will be performed at Visits 3-6 to follow up the lungs, and these CT results will be used 
to evaluate the Technical Efficacy and lung tumor progression profile.
10. During the ablation procedure, lung CT will be used to guide the microwave ablation probe to the lung tumor at a minimum 
of 3-4 time points: (1) Before probe insertion; (2) Before ablation: use CT to confirm the probe is in the expected position 
at the moment before ablation. If not in the expected position, reposition the probe and perform another scan. The doctor 
should repeat this process until the probe is placed in the expected position; (3) During ablation (optional); (4) After ablation: 
After completion of the ablation, use CT to confirm the ablation procedure has been completed and assess how the tumor 
is covered by the ablation zone.
11. As clinically necessary, the investigator can schedule a lung X-ray and/or lung CT scan as needed post-procedure within 
visit 2B for a patient to assess the occurrence of post-ablation lung complications. This is optional based on investigator’s 
determination.
12. The investigator should classify the lung tumor(s) to be ablated before the ablation procedure: (1) Stage 1A1-1A2 NSCLC:
Staging assessment should be based on images within 6 weeks before the ablation. The images should minimally include: 
"Chest CT + head MRI or CT + neck and supraclavicular lymph node ultrasound or CT + upper abdominal ultrasound or 
CT + bone scan" as recommended by 2019 edition of Chinese Medical Association Guidelines for Clinical Diagnosis and 
Treatment of Lung Cancer; "PET/CT from skull base to mid-thigh" can also be used (if available by SOC); "Mediastinal 
staging" is nice to have (if available by SOC). (2) Oligometastatic lung tumor: Images required should minimally cover 

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the primary lesion, abdomen and chest; brain MRI or CT is nice to have if investigator considers the patient with suspected 
brain metastases (if available by SOC). Besides, investigator should also assess if the tumor(s) to be ablated is a GGO 
(classification: pure GGO, partial-solid GGO, pure solid tumor).
13. During screening and enrollment, the investigator should identify the lung tumor(s) to be ablated through the pre-procedure 
lung CT imaging, assess and document the baseline profile of the lung tumor(s), including the number, size, location of the 
tumor(s) to be ablated, and the number, size and location of the other intrapulmonary tumors not to be ablated in the same 
study surgery. The size of the tumor(s) to be ablated must be measured with three-dimensional (3D) imaging in the lung 
window. For lung tumors not to be ablated in the same surgery, only need measuring size on 2D imaging together with the 
location and number. On the day of ablation, the investigator must re-assess the baseline profile of the lung tumor(s) based 
on the lung CT scan performed before the ablation procedure to make sure that all tumors to be ablated still meet the entry 
criteria.
14. The ablation procedure details must be recorded, including: date and time of procedure, mode of anesthesia, guidance 
method used, anatomical location of ablated tumors, number and types of probes used, number of ablation cycles, ablation 
power and time. For re-ablation procedures performed using the study device during the course of the study, the above 
ablation procedure details should also be recorded.
15. Pain assessment at the Visit 2A should be conducted before the ablation, and at the Visit 2B it should be conducted at 1
day and 3 days post ablation.
16. The QOL questionnaires include EORTC QLQ-C30 and lung-specific QLQ-LC13. 
17. Length of stay (LOS): The duration from completion of ablation to discharge.
18. Any unplanned hospitalization in any hospital for any reason within 30 days post-ablation will be recorded, and the 
investigator will assess the reason for re-admission and record it in the study database.
19. Evaluation of Technical Success: Both the investigators and IRC will measure and record the post-procedure maximum 
and minimum diameters of ablation zone, and minimum ablation margin on CT taken approximately 10 minutes after the 
ablation and evaluate the Technical Success or not based on the measurements.
20. Evaluation of Technical Efficacy: The assessment should be based on contrast enhanced CT performed in visit 3 and both 
investigators and IRC’s evaluations will be recorded.
21. (1) Evaluation of Local Tumor Progression: Contrast-enhanced CT scans during follow up visits will be used to evaluate 

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local malignant tumor lesion(s) at the ablation site. Both investigators’ and IRC’s evaluations will be recorded. (2) 
Evaluation of Progression-free survival: It will be based on investigator and/or the subject’s treating oncologist. If there is 
a progression, the study physician should specify if the progression is of the original target tumor, a new lung malignant 
tumor or a distant metastasis.
22. From the time of signing the informed consent form until approximately 30 days (Visit 3) after ablation (including primary 
and repeat ablation) or early discontinuation, all adverse events should be recorded. After approximately 30 days (Visit 3) 
post ablation, adverse events considered by the investigator as related to the study device or/and study procedures and all 
serious adverse events will be recorded through the end of the study or early discontinuation.
23. All relevant prior concomitant medications used within 30 days prior to Visit 1 and all relevant concomitant medications 
used throughout the study period will be recorded.
24. All concomitant procedures that are performed from 30 days before Visit 1 to the entire study period will be recorded with 
procedure name, time, location and purpose (including but not limited to paracentesis, radiotherapy, ablation therapy, 
surgical resection therapy, etc.).
25. The reason for unscheduled visit will be recorded, as well as all SAEs and AEs (if applicable), all relevant concomitant 
medications and all concomitant procedure, or any other study assessments, per SOC.

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1. SPONSOR INFORMATION
Name and Address of Sponsor
NeuWave Medical, Inc.
3529 Anderson Street 
Madison, Wisconsin, 53704 
USA
Sponsor’s Contact Information  
Richard Kocharian, MD, PhD 
Senior Medical Director, Biosurgery & NeuWave Johnson & Johnson
E-mail: rkochar1@its.jnj.com
Related Qualification Documents of Sponsor
Related qualification documents of Sponsor include: ISO 13485 etc., see relevant appendix.
Name, Address, Contact and Related Qualification Documents of Agent:
Johnson & Johnson Medical (Shanghai) Ltd.
Section C, Floor 1,2,3, No. 439 
Futexi Road, China (Shanghai) Free Trade Zone
E-mail: DL-JNJCNMP-China_MD_SAE_Reporting@ITS.JNJ.com
Tel: +86(021)3337 7968
Address: Building A, Xinyan Mansion, No. 65 
Guiqing Road, Xuhui District, Shanghai, China.
Relevant qualification documents of the agent include: business license etc., see relevant appendix.

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2. LIST OF ALL THE CLINICAL TESTING FACILITIES AND 
INVESTIGATORS PARTICIPATING IN THE CLINICAL TRIAL
See relevant appendix
3. OBJECTIVE AND CONTENTS OF CLINICAL TRIAL
3.1. Objective of Clinical Trial
The primary objective of this study is to evaluate the efficacy and safety of NeuWave Certus 
Microwave Ablation System and accessories for percutaneous microwave ablation of non-small 
cell lung cancer and oligometastatic lung tumor.
3.2. Contents of Clinical Trial
This study employs single-arm, prospective and multi-center design with single-arm performance 
goal comparing study device performance indexes with the predetermined performance goal, in 
order to evaluate study device efficacy and safety. Approximately 120 plus run-in subjects (each 
site will enroll 2 run-in subjects) of Chinese patients with non-small cell lung cancer or 
oligometastatic lung tumor scheduled for microwave ablation will be recruited. After the informed 
consent is signed, lung cancer patients according to the inclusion and exclusion criteria will be 
included in this study. All qualified subjects at the study sites will receive the same procedure: 
microwave ablation using only the NeuWave Certus Microwave Ablation System and accessories.
Subjects in this study will come to their study site for the ablation procedure. After the ablation 
procedure, the patient will be observed according to medical routine, and afterwards may return 
home. If the Study Doctor decides it is warranted for patient safety, the patient will remain in the 
hospital longer. All subjects will be required to return to their study site for at least 4 follow-up 
visits over a period of 12 months to assess the efficacy and safety of ablation.
Computerized tomography (CT) is used to evaluate the efficacy to verify whether patient’s lung 
tumor is completely ablated. CT scan will be carried out approximately 10 minutes after the ablation 
to assess Technical Success Rate and A0 Ablation Rate. Enhanced CT scan will be completed within 
30 days (±7 days) after the ablation to evaluate Technical Efficacy Rate. During the subsequent 
visits in Months 3, 6, and 12 after the ablation, subjects will receive at least one enhanced CT scan 
each time at the study site to observe whether there are imaging manifestations of tumor progression 
inside the ablation zone and at its margin. These enhanced CT scans will serve as the basis for 
determining the Local Tumor Progression. Progression-Free Survival including local, regional, or 
distant progression will also be determined according to the study physician and/or the patient’s 
treating oncologist. Another valuable endpoint during the 12-month follow-up period will be 
overall survival.
Within 30 days after the ablation (initial or repeated), all adverse events (AE) and serious adverse 
events (SAE) experienced by the patient will be evaluated; from 30 days after the ablation to the 

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ending of this study, SAE and study device/procedure-related AE determined by investigators will 
be evaluated.
Device efficacy evaluation is based on the hypothesis test of Technical Efficacy at visit 3 and the 
predetermined performance goal (PG). This efficacy result together with peri-procedural endpoints
and the safety evaluation result within 30 days after the ablation will be submitted to National 
Medical Products Administration (NMPA) for the application of lung ablation indication.
4. BACKGROUND INFORMATION OF CLINICAL TRIAL
4.1. Introduction to the Condition
4.1.1. Explanation for the Condition
Lung cancer is the most common type of cancer in the world, its morbidity and mortality rank the 
first among all malignant tumors, there are approximately 1,800,000 new cases and 1,600,000 
deaths each year1. In China, lung cancer also ranks the first among all malignancies in terms of 
morbidity and mortality, the new cases account for about 1/5 of all malignant tumors, there are 
about 780,000 new cases of lung cancer annually with an incidence of 57.26/100,000. Every year, 
the death toll of lung cancer is approximately 631,000 and the mortality rate is 45.87/100,0002. The 
incidence of lung cancer is higher in men than in women, and the risk of disease onset increases 
with age.
Based on cell types, primary lung cancer is divided into two major categories, namely non-small 
cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Among which, NSCLC has three 
main subtypes, namely squamous cell carcinoma, adenocarcinoma and large cell carcinoma, 
accounting for about 80% of all primary lung cancers, when compared with SCLC, its metastasis 
and spreading occur relatively late due to slower growth and division of the cancer cells3. The most 
important cause of primary lung cancer is smoking, because benzopyrene, nitrosamines, nicotine 
and other compounds in the smoke all have carcinogenic effects. When compared with non-
smokers, the risk for developing lung cancer is 4-10 times higher in smokers, and the smoking 
amount has an apparent dose-effect relationship with lung cancer4. Other causes of disease include 
air pollution (e.g., benzopyrene, arsenious oxide and radioactive substances that are released from 
indoor cooking fume and present in serious outdoor air pollution), occupational exposure (e.g., 
asbestos, arsenic, chromium, nickel, Ionizing radiation), and previous chronic lung infections (e.g., 
tuberculosis, bronchiectasis)5. In addition, genetic factors also play an important role in the onset 
of lung cancer, multi-step accumulation of genetic changes is considered to be related to all 
histological types of lung cancer4,6.
Secondary lung cancer refers to a malignant tumor at any site that has metastasized to the lungs 
through various metastatic routes, including blood dissemination, lymph node metastasis or direct 
invasion from adjacent organs, among which blood metastasis is the most common route. Lungs 
are the organ with the highest incidence of systemically metastatic tumors, the main reason is that 

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the lungs not only have a dual blood supply of pulmonary artery and bronchial artery but also are 
the only way that the systemic circulation must pass. In the meantime, the pulmonary circulation is 
a low-pressure system, the slow blood flow makes tumor cells easy to stagnate7. In the autopsy of 
all malignancy-related deaths, approximately 30% have lung metastases8. Primary cancers outside 
the lungs that most commonly cause lung metastases are breast cancer (16.92%), followed by 
colorectal cancer (15.86%), thyroid cancer (7.68%), liver cancer (7.48%), lymphoma (6.61%), 
kidney cancer (6.39%), esophageal cancers (6.085%), and uterine cancers (5.41%). Among 
secondary lung cancers, 80%-90% are multiple, and 10%-20% are solitary.
4.1.2. Selection of Diagnosis and Treatment Method and Disease Prognosis
The treatment of primary lung cancer includes surgical resection, radiotherapy, chemotherapy, 
thermal ablation or a combination of these methods. Among them, SCLC is usually inoperable and 
cannot be treated with local methods, because this type of lung cancer has already metastasized at 
the time of diagnosis. For advanced NSCLC, a systemic comprehensive treatment strategy is 
generally selected. For early stage NSCLC, surgical operation is the standard treatment method and 
can obtain the best prognosis. Following operation, the 5-year survival rate is 60%-80% for stage I 
NSCLC, and 40%-50% for stage II NSCLC9. Although earlier stage NSCLC benefits the most from 
surgical resection, about 1/3 of lung cancer patients cannot tolerate resection due to poor lung 
function, complications and other reasons10. For patients with primary lung cancer who cannot 
tolerate surgical operations, thermal ablation therapy has been recommended as one of the 
alternative treatments for lung cancer by various regional guidelines and consensus for the 
diagnosis and treatment of lung cancer11,12. Besides, thermal ablation therapy has also been proven 
to be effective in treating secondary lung cancer13,14.
In 2017, Chinese experts published an expert consensus on thermal ablation of primary and 
secondary lung cancers. In this consensus, thermal ablation is recommended as a curative method 
for the treatment of small primary lung cancers and small intrapulmonary metastases with good 
prognosis as shown by the biological characteristics (e.g., sarcoma, kidney cancer, colorectal cancer, 
breast cancer, melanoma and hepatocellular carcinoma) in patients who cannot tolerate surgical 
operations. In addition, it can also be combined with traditional radiotherapy and chemotherapy in 
patients with advanced large lung cancers to minimize tumor burden, relieve symptoms caused by 
tumors, and improve patient’s Quality of Life12.
In terms of the clinical results of thermal ablation therapy for primary lung cancers, two large
multicenter, prospective and observational studies in patients with stage IA NSCLC found that the 
results of thermal ablation in clinically inoperable patients are similar to the results reported in 
previous stereotactic radiotherapy, the OS of thermal ablation therapy was ~86% in 1 year and ~69%
in 2 years15,16. Two large national cancer database studies found no significant difference in OS 
between thermal ablation and stereotactic radiotherapy for early NSCLC17,18. In advanced NSCLC, 
thermal ablation is proven to be an effective treatment for local recurrence after radiotherapy. 

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Therefore, thermal ablation is considered as a palliative treatment option for advanced NSCLC12,19.
There are increasingly more literatures on the clinical results of thermal ablation for the treatment 
of secondary lung cancers, especially lung metastasis from colorectal cancer, but it is mainly based 
on observational studies. A large systematic review included 8 observational studies involving a 
total of 903 patients with colorectal cancer lung metastases. The 1-year, 3-year, and 5-year survival 
was 89%, 44%, and 19.9%, respectively, while the tumor-free survival was 60.5%, 14.4% and 7% 
respectively20. Another prospective observational study found that, for small secondary lung cancer, 
repeated thermal ablation can achieve similar survival benefits as surgical resection. This study 
included 566 patients with a total of 1037 secondary lung cancers, through repeated thermal 
ablation therapy and control of lung cancers in this population during the follow-up period, the 
median OS was 62 months, the 5-year survival was 51.5%, and the 4-year local treatment efficacy 
was 89%21.
Previous study reports on thermal ablation of lung cancer mainly focused on radiofrequency 
ablation, the number of studies on microwave ablation of lung cancer was relatively small. From 
the perspective of technical principles, however, microwave ablation has unique advantages besides 
the benefits of radiofrequency ablation: the operation time is shorter, the "heat sink effect" is 
reduced, it is less affected by the impedance, and no grounding device is needed22. As shown by 
two currently published comparative meta-analyses of microwave ablation versus radiofrequency 
ablation, both had similar effects in local tumor control, but the meta-analysis pointed out that the 
level of evidence based on the original research was low, the amount of data was insufficient for 
sub-group analysis to evaluate whether microwave ablation had a greater advantage in tumors of 
specific size or location23,24. Some research has already found better local tumor control for lung 
cancer in microwave ablation than in radiofrequency ablation25. With wider application of 
microwave ablation technology in the future, the availability of more high-level evidence data is 
expected to help evaluate the respective advantages of microwave ablation and radiofrequency 
ablation in different types of lung cancers.
4.2. Application of Investigational Product
Brace et al26 first reported the clinical efficacy and safety of investigational product Certus 
Microwave Ablation System and accessories for lung cancer ablation. Five patients received 
percutaneous microwave ablation to treat lung cancer and were followed up for 18 months, all 
ablation procedures were technically successful without local tumor recurrence or serious 
complications during follow up.
Kurilova et al27 reported the results of percutaneous microwave ablation for the treatment of 0.3-
3.2 cm colorectal cancer lung metastases, the median follow-up time was 25.6 months. Among the 
90 lung cancer lesions of a total of 50 patients, Certus Microwave Ablation System and accessories 
was used in 91% of the lesions. The total Technical Success rate was 99%, the Technical Efficacy
was 90% for the first treatment and 92% for the second treatment. During the follow-up period, 10% 

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of the tumors showed local progression, and the median OS was 58.6 months. The incidence of 
complications requiring intervention in hospital was 10%.
4.3. Product Registration Profile and Reason for Conducting the Registration Clinical 
Trial in China
The Certus Microwave Ablation System and Accessories have been cleared by the United States 
(US, country of origin) Food and Drug Administration (FDA) and has been in clinical use since 
2011 in the United States. The most common applications by clinicians have been the ablation of 
liver, lung, and kidney lesions. In addition, it is also used for the ablation of bone tumors.
Certus Microwave Ablation System and accessories have been approved by National Medical 
Products Administration (NMPA) and can be used for ablation of liver tumors from January 8th,
2020. However, there is no data on the use of this device for lung tissue ablation in the Chinese 
population. Therefore, this clinical study aims to support the registration of this device for lung 
cancer ablation indication in China.
5. FEATURES, STRUCTURAL COMPOSITION, OPERATION PRINCIPLE, 
MECHANISM OF ACTION, AND STUDY POPULATION
5.1.Features
5.1.1. Design Features of Investigational Product
This investigational product consists of Certus Microwave Ablation System equipped with software 
version 3.0.X, and NeuWave Certus PR, NeuWave Certus LK and NeuWave Certus LN microwave 
ablation probes. Several accessories are designed to allow mechanical interfacing of the power 
distribution module (PDM) with CT (computed tomography) from different vendors. These 
accessories are convenient to use without affecting the clinical functions of this system, therefore, 
they will not be described in detail.
Certus Microwave Ablation System uses a single 2.45GHz signal generator and 3 independent 
power amplifiers, each of which can generate up to 140W of power. Under ablation mode, the 
maximum output power is 65W when a single PR probe is connected, and 140W when a single LK 
or LN probe is connected, the power output time range is 1-10 minutes per transmission.
The PDM of Certus Microwave Ablation System is designed to minimize the user's setup time, 
improve the safety of operators and patients, and improve energy release efficiency at the same 
time. With the support of PDM interface, the users can connect with power source, electrical signal 
and cooling line of Certus energy release accessories in just one step. In percutaneous applications, 
PDM can be directly mounted on CT bed so that it can move with the CT bed during imaging. The 
probe and cable will also move synchronously with the patient, this can greatly reduce the risk of 
patient injuries due to accidental movement of the probe and cable. In open surgery applications, 
PDM can be directly mounted on Certus mainframe or on the operating table. In addition, PDM 

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uses wider and highly efficient cables to connect with the power amplifier. Since a wider cable can 
increase energy transfer efficiency, it is able to transfer more energy to the energy release accessory.
Certus Microwave Ablation System uses CO2 cooling system to ensure that non-radiation part of 
the probe does not exceed the temperature requirements, while all other microwave ablation 
systems use sterile water for cooling purpose, but there is no difference between risks related to 
this air cooling system and inherent risks of water-cooled cryoablation systems widely accepted in 
clinical practice. Thus, the Certus system does not introduce new hazards.
The ablation probes include 3 general types, namely Certus LK, LN and PR. Certus LK and LN 
probes are specifically used to achieve higher energy transfer efficiency in the tissues in order to 
cover a larger ablation area. Certus LK probe can be used in lung ablation. Certus LN probe is 
specially designed for lung tissue properties and limited to the use in lung tissues to optimize energy 
transfer efficiency of the probe in lung tissues. Certus PR probe is specifically designed to limit the 
length of ablation, for example, when a small ablation zone is needed, it can realize the ablation 
effect by quickly wrapping the antenna and limiting the anterior ablation length. When compared 
with other Certus probes, Certus PR probe can not only provide doctors with a smaller ablation 
area but also limit necrosis of the anterior distal tissues.
5.1.2. Material Features of Investigational Product
Material properties of disposable microwave ablation probes of this investigational product
Code 
No.
Component
Material properties
1
Ablation probe
Titanium (except for PR ablation probe); titanium, aluminum 
coating (PR ablation probe)
2
Radiation area
Zirconia, FEP heat shrink tubing (whole body, except for 
antenna)
3
Tissue loc zone
Stainless steel, FEP heat shrink tubing (whole body, except for 
antenna)
4
Insertion depth mark
Stainless steel, FEP heat shrink tubing (whole body, except for 
antenna)
5
Cauterize stop mark
Stainless steel, FEP heat shrink tubing (whole body, except for 
antenna)
6
Ablation probe shaft
Stainless steel, FEP heat shrink tubing (whole body, except for 
antenna)
7
Handle, LED light
ABS resin
8
Protective sheath
Polypropylene
5.2.Structural Composition, Operation Principle, Mechanism of Action

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5.2.1. Composition of Investigational Product
This investigational product consists of Certus Microwave Ablation System and microwave 
ablation probes (Certus PR, Certus LK and Certus LN) made by NeuWave Medical. The system 
consists of a generator, an energy module PDM (probe interface unit, connected to ablation probe 
of the system), a temperature measurement system, a cooling system using CO2 cylinder (the 
cylinder is not included in the registration device), software and CT brackets.
The Certus microwave ablation probe consists of a handle (with LED indicator), coaxial connector, 
cable, ablation probe shaft, microwave radiation ablation antenna tip, 3 temperature sensors and a 
CO2 circulation loop.
Schematic diagrams of the system and ablation probe product are as follows:
NeuWave Certus Microwave Ablation System
Schematic diagram of Certus Microwave Ablation Probes and components (Taking PR probe for 
example)

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Note: 1-cannula, 2-radiation point, 3-Tissue-loc area, 4-insertion depth mark, 5-cautertize stop mark, 6-
shaft axis, 7-handle/LED, 8-protective sleeve.
5.2.2. Operation Principle and Mechanism of Action of Investigational Product
In this investigational product, the mainframe of Certus Microwave Ablation System generates 
2450MHz microwave energy through microwave source, power amplifiers and DC module. 
Microwave energy is transmitted to the ablation probe through connected cable, and then delivered 
to the tumor site waiting for treatment through the ablation probe. Under the action of microwave 
magnetic field, water, protein and other polar molecules in tumor tissues vibrate in high speed to 
cause collision and friction between these molecules. As a result, a high temperature up to 60°C-
150°C is generated within a short time, leading to coagulative necrosis of the cells and subsequent 
necrosis of tumor tissues. This system is controlled by an easy-to-use touch screen user interface. 
Each power amplifier can generate up to 140W of microwave. Generator power is limited by the 
selected probe type. Up to 3 microwave ablation probes can be connected each time to receive 
energy transmission. If Certus system is malfunctioning, the system will automatically stop 
emitting microwave energy. The Certus Microwave Ablation System and Accessories are general 
purpose thermal ablation tools used by physicians to ablate soft tissue lesions in a wide variety of 
tissue and disease states (including lung tumors) in the United States.
The PDM is designed to improve system utility by reducing device complexity and minimizing 
wiring from the probe to the generator. In addition, PDM also helps use wider and lower loss cables 
between microwave generator and PDM. Wider cables in combination with PDM can safely deliver 
more energy to the ablation probe without incurring risks due to heated probe cable or handle.
The principle of CO2 cooling system is to deliver high-pressure CO2 to gas circulation loop within 
the ablation probe. When the pressure drops rapidly, the resulted Joule-Thomson effect will cool 

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the ablation probe. The system uses two CO2 cylinders to supply gas to the cooling system. When 
the gas cylinder becomes empty, the system will automatically switch to another gas cylinder and 
notify the user to replace empty cylinder. CO2 temperature and pressure can be monitored and 
automatically adjusted by the system to maintain CO2 cooling effect. This cooling system can 
ensure that non-radiation parts of the probe will not exceed the temperature requirement. In addition, 
a Tissue-loc effect can be formed to help adhere ablation probe to the tissues during pre-ablation 
imaging period and initial ablation stage, thereby reducing displacement risk of the ablation probe 
placed in tissues.
Microwave ablation probe is a sterile device, and each probe is for one-time use only for patients. 
The probe adopts a three-dimensional antenna design, the principle is to let a coaxial unipolar 
antenna pass through a hollow needle. The probe constitutes a three-dimensional structure, and the 
antenna is located besides the unipolar base-the distance is about 1/4 of the wavelength. This 
position improves antenna efficiency and reduces microwave field reflux of the coaxial outer 
conductor. Subsequently, more energy can accumulate within the tissues.
5.3.Study Population
This study will enroll at least 120 plus run-in subjects (each site will enroll 2 run-in subjects) of 
Chinese patients with NSCLC or oligometastatic lung tumor who are scheduled to be hospitalized 
for microwave ablation. For each patient, tumor(s) to be ablated in a single procedure should be a 
maximum of one ipsilateral biopsy proven NSCLC tumor with documented results or a maximum 
of three ipsilateral oligometastatic lung tumors with a clinical diagnosis. Each tumor to be ablated 
should be 
2cm and locates in outer two-thirds of a lung.
6. PRODUCT INDICATIONS AND CONTRAINDICATIONS, PRECAUTIONS
[Indications]
The Certus Microwave Ablation System and Accessories are intended to ablate/coagulate soft 
tissues. The Certus Microwave Ablation System and Accessories are general purpose thermal 
ablation tools used by physicians to ablate soft tissue lesions in a wide variety of tissue and disease 
states. The most common applications by clinicians have been the ablation of liver, kidney and lung 
lesions. Additional, but less common uses have been the ablation of soft tissue lesions in bone and 
nerve ablation.
[Contraindications]
The Certus Microwave Ablation System and Accessories are contraindicated for:
-
Cardiac operation
-
Pregnant patients, potential risks to patient and/or fetus have not been established.
-
Patients with implantable pacemakers or other electronic implants. Implanted electronic 
devices may be adversely affected by MW power.

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-
Central nervous system ablation
[Precautions]
All hazards associated with the use of the Certus system have been identified and appropriately 
mitigated. Design considerations were taken to reduce the risks associated with existing MW 
ablation systems, including improved system usability and cable management.
-
Probe temperatures are highly dependent on tissue variables such as perfusion and 
vasculature. Probe temperatures are likely to vary from procedure to procedure based on 
these tissue variables. These temperature variations do not, by themselves, indicate a 
malfunctioning probe or system.
-
Electrosurgical/electrocautery devices may interfere with the Certus system and cause 
system errors. Ensure that all Certus probes are removed from the patient prior to using 
electrosurgical/electrocautery devices.
-
Use only Certus Ablation Probes from NeuWave Medical with the Certus Ablation System. 
Probes from other manufacturers may cause patient injury or make the product function 
improperly.
-
The Certus system uses a CO2 cooling system where all other MW systems use sterile 
water, but the risks associated with this cooling system do not differ from the risks inherent 
in cryogenic ablation systems, also widely accepted in clinical use. Thus, the Certus 
system does not introduce new hazards.
-
This product should only be used by clinicians and staff properly trained in the use of the 
technology and its associated warnings and cautions.
-
Refer to the Certus Microwave Ablation System and Accessories accompanying 
documents for a complete and comprehensive list of Warnings and Cautions.
7. OVERALL DESIGN
7.1. Trial Design
7.1.1. Trial Objective
The primary objective of this study is to evaluate the effectiveness and safety of the NeuWave 
Certus Microwave Ablation System and Accessories in the percutaneous microwave ablation of 
NSCLC or oligometastatic lung tumor.
7.1.2. Trial Method Selection and Its Rationale
This is a prospective multicenter study with single-arm performance goal. The prospective study 
design can reduce bias and provides better data accuracy without any needs for recall. A single-arm 
design with performance goal is adopted. Due to the lack of published objective performance 
criteria (OPC), the performance goal (PG) is constructed as the target value. The statistical 
considerations are to calculate point estimate of the primary study endpoint and its corresponding 

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95% confidence interval. This 95% confidence interval will be compared with clinically significant 
PG predefined in the protocol to determine whether this investigational product has reached the 
minimum standards recognized in the professional field. Based on the scientific hypothesis that the 
primary endpoint is superior to PG, and the permissible type I and type II errors, the 
correspondingly required sample size will be estimated to ensure statistical significance of the 
results.
7.1.3. Measures to Reduce and Avoid Bias
This study adopts a prospective design to avoid possible bias of retrospective study. The 
Independent Review Committee (IRC) will be set up for the determination of key endpoints in 
order to standardize and unify the evaluation methods, and to avoid potential bias caused by 
surgeon's judgment.
This study collects data on objective indexes, and all relevant study data will be recorded in the 
original medical records for inspection and verification during the monitoring process. All 
investigators will receive proper training to ensure that they are familiar with this study device 
before their study sites are initiated, and to ensure scientific attitude of the study personnel. In 
addition, each study site will set a run-in period to include the first 2 subjects treated at this site, 
but these subjects will be included in the safety set only. This is intended to reduce operational bias 
due to learning curve.
The investigator should have more communication with the subjects to improve subject compliance. 
This will help reduce the informational bias.
7.1.4. Investigational Medical Device
Study Device Composition 1
Certus Microwave Ablation 
System
Study Device Composition 2
Certus microwave ablation probe
Figure
Entering 
global market 
(year)
Global: 2011
Global: 2011

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Study Device Composition 1
Certus Microwave Ablation 
System
Study Device Composition 2
Certus microwave ablation probe
Indications
Certus Microwave Ablation 
System and accessories are 
applicable for soft tissue 
ablation (coagulation) in 
percutaneous, open surgery 
and laparoscopic surgery.
Certus disposable microwave ablation probe is a 
dedicated accessory of Certus Microwave Ablation 
System, and applicable for soft tissue ablation 
(coagulation) in percutaneous, open surgery and 
laparoscopic surgery.
Components
It consists of a generator, a 
PDM (probe interface unit, 
connected to ablation antenna 
of the system), a temperature 
measurement system, a 
cooling system using CO2 gas 
cylinder (the cylinder is not 
included in the registration 
device), software and CT 
brackets.
It consists of a handle (with LED indicator), coaxial 
connector, cable, ablation probe shaft, microwave 
radiation tip, 3 temperature sensors, and a CO2
circulation loop.
Dimension
Width: 23" (58.4 cm) 
Depth: 28" (71.1 cm) 
Height (including display): 
52" (132 cm) (minimum), 59" 
(150 cm) (maximum) 
Weight: ~250 pounds (113 kg)
Certus PR and Certus LK models use 17 gauge and 
15-gauge probes.
Certus LN model uses a 17-gauge probe.
All models of probes have 15 cm and 20 cm in 
length.
Material
NA
Ablation probe
Titanium (except for PR 
ablation probe); titanium, 
aluminum coating (PR 
ablation probe)
Ablation probe shaft, 
radiation zone, tissue 
loc area, insertion 
depth mark, cauterize
stop mark
Zirconia, FEP heat shrink 
tubing (whole body, except 
for antenna)
Handle, LED light
ABS resin
Protective sheath
Polypropylene
7.1.5. Selection of Subjects:

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1) Inclusion criteria
Subjects will be included if ALL of the following inclusion criteria are met:
1.
Signed the informed consent form and willing to fulfill the study-related assessments and 
procedure schedule.
2.
Lung tumor patients 
18 years of age who are ineligible for/decline surgery and who 
plan to receive microwave ablation therapy.
3.
ECOG performance status score of 0-2.
4.
Patients with stages IA1-IA2 NSCLC with documented results from a biopsy or patients 
with clinically diagnosed oligometastatic lung tumor.
5.
Tumor(s) to be ablated in a single surgery should be a maximum of one NSCLC tumor or 
a maximum of three ipsilateral oligometastatic lung tumors. 
6.
Tumor(s) to be ablated in a single surgery should be 
2cm, locate in the outer two-
thirds of a lung, not closer than 1cm from the hilum of lung, great vessels, principal 
bronchus, trachea or esophagus, and not contiguous with the pleura.
2) Exclusion Criteria
Subjects who meet ANY of the following exclusion criteria will be excluded:
1.
Pregnant or breast-feeding.
2.
Patients with implantable pacemakers or other electronic implants. 
3.
Oligometastatic tumors patients whose primary lesion cannot be controlled or have 
widely metastases, in the opinion of the investigator and/or treating oncologist.
4.
Any planned concurrent procedure at the time of ablation.
5.
Planned treatment for other tumors in the same side lung during the study period.
6.
With a skin infection or ulceration at the site to be punctured by probe(s).
7.
Clinical or imaging findings consistent with an active pulmonary infection.
8.
Patients with severe pulmonary fibrosis in the area intended to ablate, especially drug-
induced pulmonary fibrosis.
9.
Patients with prior radiotherapy in the area intended to ablate.
10. Patients with uncontrolled malignant pleural effusion at the lung side with tumor to ablate.
11. Tumors where the anticipated zone of ablation would encompass significant (in the 
opinion of the treating physician) emphysematous or bullous disease.
12. The investigator anticipates that the ablation zone of the multiple tumor(s) to be ablated 

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may have overlapping ablation zones.
13. Patients who have received lung ablation or surgical resection therapy within 30 days 
prior to the ablation procedure under study and those who plan to receive lung tumor 
ablation or surgical resection therapy or radiation therapy on the ablated lung side before 
completing the primary efficacy endpoint assessment approximately 30 days after the 
ablation procedure.
14. Patients who received systemic therapy such as chemotherapy, targeted drug therapy, or 
immunotherapy within 7 days prior to the ablation procedure under study, and patients 
who had a systemic treatment plan such as chemotherapy, targeted drug therapy, 
immunotherapy, etc. before completing the primary efficacy endpoint assessment 
approximately 30 days after the ablation procedure.
15. Patients with uncorrectable coagulopathy based on investigator judgment.
16.
9/L.
17. Patients who cannot discontinue antiplatelet medication (e.g., aspirin, clopidogrel, 
prasugrel, ticagrelor) at least 5 days before the ablation procedure through 24 hours post-
procedure.
18. Patients who cannot discontinue anticoagulant medication (e.g., rivaroxaban, apixaban, 
dabigatran, edoxaban) at least 3 days before the ablation procedure through 24 hours
post-procedure.
19. Patients who cannot discontinue warfarin before at least 5 days before the ablation 
procedure of the study or have an INR > 1.5. 
20. As judged by the investigator, the patient has hypertension that cannot be effectively 
controlled by pharmacological treatments.
21. Severe hepatic, renal, cardiac, pulmonary or cerebral insufficiency, severe anemia, 
dehydration, and severe nutrition and metabolism disorders, which cannot be corrected 
or improved within a short term; or serious systemic infection; or severe neuromuscular 
diseases.
22. Expected survival less than 6 months.
23. Participation in any other interventional clinical study within 30 days before screening.
24. Physical or psychological condition which would impair study participation.
25. Patient is judged unsuitable for study participation by the investigator for any other reason.

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Intra-Ablation Exclusion Criteria:
26. Before ablation probe puncture on the skin, patient is judged unsuitable for study 
participation due to intolerance to anesthesia.
27. Before ablation probe puncture on the skin, patient is judged unsuitable for study
participation due to presenting any other condition.
3) Criteria of and procedure of Study Discontinuation
The criteria for Subject’s Discontinuation from Study include, but are not limited to: 
1. Subject withdraws the informed consent: Subject decides to withdraw from the study. This 
decision must be an "independent decision" and should be recorded in the subject's study files; 
2. Investigator's decision: According to reasonable medical determination, the investigator can 
decide that allowing the subject to withdraw from this study serves the subject's best interests
(including subject’s discontinuation from the study due to the procedure being stopped before 
the ablation began);
3. Adverse events (AE)/serious adverse events (SAE): AE/SAE may not cause the subject to 
terminate this study. If the investigator decides to terminate a subject from the study, this subject 
must be followed up, until the AE/SAE is resolved or until the stable clinical endpoint is reached
or until the event is adequately explained.;
4. Subject died;
5. Lost to follow-up: all subjects should provide corresponding contact information and agree to 
participate in all planned clinical follow-ups. If the subject cannot return to complete the 
required clinical visit, then 3 telephone contacts should be attempted and ask the subject to 
return for the scheduled clinical visit. Each contact attempt should be recorded in the original 
medical record. If the subject does not respond to any of the 3 phone calls, the investigator must 
send the subject a registered letter or an express mail (EMS) that can record the sending and 
receiving information. If the subject does not respond to the registered letter or EMS, and no 
further contact is made, this subject should be regarded as having missed the scheduled visit. If 
the above contact attempts still fail in 1 month after the ending of last scheduled visit, then this 
subject will be regarded as lost to follow-up; at this time, the electronic case report form (e-CRF) 
at the end of study must be filled in;
6. The sponsor discontinues the study; 
7. The health authorities request study termination.
Procedure for subject’s discontinuation from the trial: 
If the subject discontinues the study, the reasons for termination will be documented in the source 
document and site files and submitted via the eCRF.
For a subject that discontinues the study due to procedure stop before ablation power emitting and 

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after probe puncture on the skin, there will be a new subject enrolled as a replacement. No 
replacement plan for other discontinued subjects.
Criteria of Sponsor’s Discontinuation of the Trial:
Sponsor has the rights to temporarily suspend/discontinue or prematurely terminate studies of a 
single site, multiple sites or all sites for reasons including but not limited to: safety issues, ethical 
issues, administrative issues, inaccurate or incomplete data records, non-compliance, the quality or 
quantity of recruited subjects is not satisfactory.
Flow of Sponsor’s Discontinuation of the Trial:
If the sponsor decides to suspend or terminate the clinical trial, it shall notify the medical device 
clinical trial management departments of all the clinical trial institutions according to regulatory 
requirements and provide reasons in writing. The departments shall promptly notify corresponding 
investigators and ethics committees. Suspended clinical trials shall not be resumed without the 
approval of the ethics committees.
4) Time of enrollment
Subjects are considered as being enrolled when they have completed the followings:
•
Completion of the informed consent process;
•
The investigator determines that the subject has met all the inclusion criteria without 
meeting any exclusion criteria.
Before the informed consent is signed, no study-related operating procedures can be implemented.
5) Expected overall duration of clinical trial and reasons for determination
The expected overall duration is approximately 40 months, including ethics committee meeting, 
agreement signing, subject enrollment and follow-up, data management, statistical analysis, writing 
final clinical report, etc.
6) Expected duration of participation of each subject
According to the Schedule of Activities specified in the protocol, the duration of each subject’s 
participation in the study will be 13 months (about 1 month for Screening and 12 months for follow-
up). The follow-up schedule will be based on the original ablation procedure date. A re-ablation for 
any reason will not change or extend the follow-up visit schedule.
7) Number of subjects required for clinical trial
This study plans to enroll 120 subjects plus run-in subjects (each site will enroll 2 run-in subjects) .
Because this is a single-arm study, there will be no randomization of subjects. See Section 8 
"Sample size calculation" for this sample size selection basis
7.1.6. Efficacy Evaluation Method

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1) Description of efficacy parameters
The primary efficacy endpoint: 
Technical Efficacy Rate, defined as the percentage of tumor that is completely covered by the 
ablation area without signs of pathological enhancement as assessed by lung enhanced CT at 
Visit 3 (i.e., 30 days±7 days after the first ablation).
Secondary efficacy endpoints: Including Technical Success Rate, A0 Ablation Rate, Re-ablation 
Technical Success Rate, Local Tumor Progression, Progression-Free Survival, and Overall Survival.
The respective definitions are as follows:
1.
Technical Success Rate: Percentage of tumors that achieve A0 or A1 ablation (i.e., the 
ablation zone covers the tumor completely and has a surrounding margin) in the lung CT 
immediately following the initial ablation procedure.
2.
A0 Ablation Rate: Percentage of tumors that achieve A0 ablation (i.e., the ablation zone 
covers the tumor completely and has a margin of at least 5 mm for secondary lung tumors 
and at least 10 mm for primary lung tumors) in the lung CT immediately following the 
initial ablation procedure.
3.
Re-Ablation Technical Success Rate: Percentage of tumors that achieve Technical 
Success in the lung CT immediately following the repeat ablation with the study device
during the study.
4.
Local Tumor Progression: Local tumor progression and time to local tumor progression 
of any original-ablated tumor(s). 
5.
Progression-Free Survival:  Length of the time the patient is still alive after the original 
ablation procedure and with no evidence of any tumor progression (Local, regional, or 
distant).
6.
Overall Survival: Length of time that the patient is still alive after the original ablation
procedure within the study duration.
2) Selection of method and time to evaluate, record and analyze the efficacy 
parameters
For efficacy parameters including Technical Efficacy, Technical Success, A0 Ablation, Re-Ablation 
Technical Success and Local Tumor Progression, IRC will be used to evaluate the CT images in 
order to achieve standardization and consistency defined in the protocol and to reduce biases in 
surgeon's judgment. Investigator’s evaluation results will also be recorded. Both results will be 
recorded in the e-CRF. The composition of IRC and endpoint definition details will be described 
thoroughly in a separate imaging chapter, which will be finalized before the first patient is enrolled. 
Primary statistical analysis and hypothesis testing for the primary effectiveness endpoint will be
based on IRC’s evaluation results.

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For effectiveness endpoints Progression-Free Survival and Overall Survival, they will be based on
reports by study physician and/or subject’s treating oncologist. The evaluation results will be 
recorded in the e-CRF and reported in the final clinical study report.
Primary efficacy endpoint: 
o
Technical Efficacy Rate will be determined according to lung enhanced CT at Visit 
3 (30 days±7 days after surgery).
Secondary efficacy endpoints:
o
Technical Success Rate, A0 Ablation Rate, and Re-ablation Technical Success Rate:
determined according to the maximum diameter, minimum diameter and minimal 
ablative margin of the ablated lesions as measured by lung CT approximately 10 
minutes after ablation.
o
Local Tumor Progression: determined by lung enhanced CT after initial ablation.
o
Progression-Free Survival will be determined by study physician and/ or be reported 
by the patient’s oncologist after initial ablation.
o
Overall Survival will be determined based on investigator recorded ablation time and 
death time.
See Section 8 for analytical methods of the above endpoints.
7.1.7. Exploratory Parameters Evaluation Method
1
Description of exploratory parameters
Exploratory parameters include:
1. Patient-reported outcomes:
Ablation-Procedure Related Pain: Compare the 1 day, 3 days, 1-month post-ablation versus 
pre-ablation patient-reported pain levels using the Numeric Pain Rating Scale.
Quality of Life: Compare the patient’s 1 month post-ablation, 6 months post-ablation, 12 
months post-ablation to the pre-ablation Quality of Life scores using EORTC QLQ-C30 
and Lung-specific QLQ-LC13.
2. ECOG Performance Status: Patient functionality as measured by distribution of Eastern 
Cooperative Oncology Group (ECOG) classification scores over time.
3. Ablation Procedure Related Indicators: Number and types of probes used, number of ablation 
cycles, ablation power and time.
4. Length of hospital stay: The duration from the patient’s completion of ablation procedure to 
discharge.
5. Re-Admission Rate: Percentage of subjects with unplanned hospital admission or re-admission
due to adverse event occurring within 30 days after any ablation procedure using the study device

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(i.e. the original ablation or a repeat ablation).
2
Selection of method and time to evaluate, record, and analyze the exploratory 
parameters
Ablation Procedure-Related Pain and Quality of Life will be based on patient report digital pain 
rating scale results at Visits 2B, and 3 and EORTC QLQ-C30 and lung-specific QLQ-LC13 at Visits 
3, 5, and 6. The results will be recorded in the e-CRF.
The following exploratory endpoints evaluated by investigators will be recorded in the e-CRF:
ECOG Performance Status is based on performance score at Visit 1, Visit 2B, Visit 3-6.
Ablation Procedure Related Indicators are based on investigator's assessment of the 
ablation procedures at Visit 2A or any other Visits using study device for re-ablation.
Length of Hospital Stay is based on ablation and discharge time recorded by the 
investigator during Visit 2A and Visit 2B.
Re-Admission Rate is based on the investigator recorded readmissions.
See Section 8 for analytical methods of the exploratory parameters.
7.1.8. Safety Evaluation Method
1) Description of safety parameters
Safety parameters include:
All AEs from the start of any ablation procedure (from the probe puncture on skin) to 30 days 
post-ablation or early discontinuation.
All SAEs from the start of ablation procedure through the end of the study or early 
discontinuation. 
All device-related AEs, procedure-related AEs, device-related SAEs and procedure-related 
SAEs from the start of ablation procedure through the end of the study or early 
discontinuation. 
The incidence of the prespecified AEs below will also be summarized and reported:
1. Pneumothorax (all and those requiring chest tube drainage)
2. Hemorrhage (all and those requiring treatment)
3. Post-ablation syndrome
4. Chest wall pain
5. Pleural effusion (all and those requiring chest tube drainage)
6. Pneumonia
7. Lung or chest abscess
8. Other infections
9. Bronchopleural fistula

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2) Selection of method and time to evaluate, record, and analyze the safety 
parameters
From the time of signing the informed consent form until approximately 30 days (Visit 3) after 
ablation (including primary and repeat ablation) or early discontinuation, all adverse events will be 
recorded. During this period, all adverse events from the start of ablation (i.e., probe puncture on 
the skin) will be reported.
After approximately 30 days (Visit 3) post ablation, adverse events considered by the investigator 
as related to the study device or/and study procedures and all serious adverse events will be 
recorded and reported till the end of the study or early discontinuation.
For subjects who stop ablation and withdraw from the study without ablation power emission while 
the needle has punctured the skin during the ablation procedure, the subject will be followed up for 
safety events up to 30 days after the procedure. If the discontinued subject reports a serious adverse 
event, the subject will be followed until event resolution, stabilization, or until the event is 
adequately explained.
The safety parameters will be recorded on the e-CRF according to the investigator’s record, medical 
record, and all other related source documents collected at each follow-up visit.
See Section 8 for safety endpoint analysis methods.
7.2. Trial Flow
7.2.1. Trial Flow Chart
Refer to Table 1: Schedule of Activities, which may be found at the end of the Protocol Synopsis.
7.2.2. Specification for Device Use
According to Instructions For Use (IFU) and technical manual of the product, the requirements for 
the use of study product are as follows:
Indications/scope of application
Study Product: Certus Microwave Ablation System and Accessories, intended to ablate/coagulate 
soft tissues. The Certus Microwave Ablation System and Accessories are general purpose thermal 
ablation tools used by physicians to ablate soft tissue lesions in a wide variety of tissue and disease 
states. The most common applications by clinicians have been the ablation of liver, kidney and lung 
lesions. Additional, but less common uses have been the ablation of soft tissue lesions in bone and 
nerve ablation.
Recommended operation mode
Physicians who are experienced with tumor ablation will do all ablations percutaneously using only 
the NeuWave Certus Ablation System. During the ablation, subjects will be under an anesthesia as 
per the institution’s SOC. In this study, microwave ablation is a minimally invasive procedure that 
uses electromagnetic waves to generate tissue necrosis in the lung tissues. Using CT scan guidance, 

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a probe is inserted percutaneously into the lesion.
The ablation will be performed with a single high-powered, gas-cooled, multiple antenna-capable 
MW system (NeuWave Medical’s Certus Ablation System and Accessories) with single-probe 
antenna for single tumor, according to the IFU and the performing physician’s clinical judgment. 
Electromagnetic waves are delivered to the tissue, producing frictional heating to generate tissue 
necrosis at > 60°C. Duration of the ablation and power application will be determined by the 
performing physician based on manufacturer guidelines, with adjustment for tumor size, proximity
to vulnerable structures, and real-time intraprocedural monitoring. Single or multiple ablation 
sessions may be done in one procedure.
The Certus Ablation System rests on a cart that contains the MW power amplifiers and cooling 
system. The user interface for the Certus Ablation System is a system display to access all controls 
and settings. When ready to begin the procedure, the display will be used to select the organ
locations in which probes will be inserted during the procedure.
Target ablation involves placing a probe into a substantial target and then ablating for up to several 
minutes until the target tissue is necrotic. This can be done by percutaneous surgery. In Ablation 
Mode, power delivery times can be set from 1 to 10 minutes per delivery. The efficiency at which 
different types of soft tissue receive MW energy differ based on the electrical properties of the 
tissue. For lung tissue ablation, the investigator should select the probe type based on the size, 
location, etc. of the tumor and the patient ’ s underlying condition, and use the device for ablation 
in the study according to the Instructions for Use (IFU).
Ablation time and power will also be controlled via the system display, which has buttons to control 
for Time and Power. Pressing the buttons next to the Time box adds or subtracts from the Target 
Time in 1-minute increments. The buttons next to the Power box add or subtract from the Power in 
5-Watt increments.
Each connected probe must successfully pass a functional test before Tissu-Loc, Ablate, or 
Cauterize buttons are activated. The functional test must be conducted and passed before a probe 
may be used for ablation or surgical functions. Once a probe passes test, the functional controls 
become active.
Pressing the Ablation Tissu-Loc button starts the CO2 cooling system to cool the Tissu- Loc zone 
in the probe to between 0 and -15°C. Once the Tissu-Loc Zone temperature reaches -5°C, the button 
turns gray, a green check mark appears on the button, and the button text reads ‘Stop Tissu-Loc’.
The Probe Temperature is displayed below the probe image. A green highlighted outline appears 
around the Time box to indicate that power is being delivered. The Time display begins to count 
down from the target Time or count up to the target Time. An audible tone sounds continuously to 
indicate that power is being delivered. If more than one probe is delivering power, the audible tone 
changes pitch.
When the Stop Ablate button or Stop All Ablation Bar is pressed, energy delivery is stopped, and 

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the Ablation Time is displayed below the Time Box. This indicates the total time that power has 
been delivered via that probe. The probe temperature remains on the display.
A cauterizing feature is available to cauterize the insertion track when removing the probe from the 
patient. This feature is to cauterize the insertion track only. It should not be used to ablate or 
cauterize target tissue. Only one probe can be used in Cauterize mode at a time. No other probes 
may be delivering energy when cauterizing with a probe.
After the probe is removed from the patient, the Certus Ablation System cart may be wheeled to 
the side to allow the doctor to clean and bandage the probe insertion site.
Warnings and precautions
All hazards associated with the use of the Certus have been identified and appropriately mitigated. 
Design considerations were taken to reduce the risks associated with existing MW ablation systems, 
including improved system usability and cable management.
Important: Probe temperatures are highly dependent on tissue variables such as perfusion and 
vasculature. Probe temperatures are likely to vary from procedure to procedure based on these tissue 
variables. These temperature variations do not, by themselves, indicate a malfunctioning probe or 
system.
Electrosurgical/electrocautery devices may interfere with the Certus system and cause system errors. 
Ensure that all Certus probes are removed from the patient prior to using electrosurgical/electrocautery 
devices.
Use only Certus Ablation Probes from NeuWave Medical with the Certus Ablation System. Probes from 
other manufacturers may cause patient injury or fail to function properly.
The Certus system uses a CO2 cooling system where all other MW systems use sterile water, but the 
risks associated with this cooling system do not differ from the risks inherent in cryogenic ablation 
systems, also widely accepted in clinical use. Thus, the Certus system does not introduce new hazards 
or intended uses.
This product should only be used by clinicians and staff properly trained in the use of the technology 
and its associated warnings and cautions.
Refer to the Certus Microwave Ablation System and Accessories accompanying documents for a 
complete and comprehensive list of Warnings and Cautions.
7.2.3. Study Procedure
1) Visit 1 - Baseline/Screening Visit
The following screening procedures should be performed before the study procedure, and all 
screening procedures should be completed within 30 days before ablation:

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The patient must be given ample time to review and sign the ICF.
Collect demographic information (year and month of birth, sex, race, ethnicity), body 
height and body weight.
Blood or urine pregnancy test shall be performed for women of childbearing potential and
should be performed within 7 days prior to the ablation; otherwise the test must be 
repeated and available prior to ablation. 
Laboratory tests: including complete blood count (including differential count), 
coagulation test (APTT, PT and INR) should be performed within 7 days prior to the 
ablation; otherwise the test must be repeated and available prior to ablation.
Collection of relevant medical/surgical/radiation history
at least include previous 
diagnosis of systemic tumors and pathological results (if any), history of other non-tumor 
lung 
diseases, 
history 
of 
chronic 
diseases, 
history 
of 
oncologic-related 
mediation/surgery/procedure/radiation history and smoking status.
ECOG performance status score.
Subjects must receive at least one contrast-enhanced CT scan of the lungs in the study 
site within 30 days prior to ablation (Visit 2A).
The investigator should record the baseline information of all lung tumors observed on 
the pulmonary enhanced CT before ablation, including: 
-
The number, location, size of the tumor to be ablated. The size of the tumor to be 
ablated must be measured using three-dimensional (3D) imaging on the lung window. 
-
Whether the tumor to be ablated has been examined by biopsy before ablation, and 
the biopsy time and results should be recorded.
-
The number, location and size of other non-ablated tumors in the lung. For tumors
not to be ablated, only need measuring size on 2D imaging.
The investigator shall classify and determine the tumors to be ablated according to 
preoperative lung CT images as follows:
-   Classify the lung tumors to be ablated into:
Stage 1A1-1A2 NSCLC; 
Oligometastatic lung tumor;
o
NSCLC should be diagnosed based on biopsy results. NSCLC staging 
assessment should be based on images within 6 weeks before the ablation. The 
images requirements are
-
Minimally include: “Chest CT + head MRI or CT + neck and 
supraclavicular lymph node ultrasound or CT + upper abdominal 
ultrasound or CT + bone scan” as recommended by the 2019 edition 

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of Chinese Medical Association Guidelines for Clinical Diagnosis and 
Treatment of Lung Cancer; 
-
Acceptable if available by SOC: “PET/CT from skull base to mid-
thigh”;
-
Nice to have if available by SOC: “Mediastinal staging”.
o
The images requirements for oligometastatic lung tumor diagnosis are
-
Minimally cover the primary lesion, abdomen and chest; 
-
Nice to have if available by SOC: brain MRI or CT if the investigator 
considers the patient having suspected brain metastases.
-
The determination of whether the lung tumor to be ablated is GGO will be made by 
the investigator and classified as: pure GGO, partial solid GGO, and pure solid tumor.
Quality of Life assessment: including EORTC QLQ-C30 and lung-specific QLQ-LC13.
All relevant prior medications taken within 30 days of visit 1will be recorded, including 
blood-thinning/anticoagulants, chemotherapy/targeted therapy/immunotherapy and other 
anti-neoplastic agents, steroids, anti-inflammatory drugs, NSAIDs, antibiotics, and drugs 
used to treat relevant medical history.
For all anti-tumor agents used prior to ablation, the pre-ablation withdrawal time should 
also be recorded.
The name, time, location and purpose of all concomitant procedures within 30 days before 
visit 1 (including but not limited to puncture, radiotherapy, ablation therapy, surgical 
resection, etc.) will be recorded.
Review inclusion/exclusion criteria and determine whether the patient meets the 
participation criteria.
Record AEs and SAEs from signing the ICF.
Pre-Ablation Screening
Subjects will be consented prior to any actual study-specific screening procedures being conducted. 
Subjects will be considered enrolled into the study upon satisfaction of the following criteria:
•
Completion of the informed consent process and signing the Informed Consent Form 
(ICF).
•
Verification of the eligibility criteria by the Principal Investigator (PI) and/or authorized 
investigators. The verification must be conducted by the PI and/or authorized investigators 
prior to performing any study-related procedure or completing any form associated with this 
study.
Pre-Ablation Screening Failures

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Subjects who have signed the informed consent form but are not included in the study after pre 
ablation screening will be considered screening failures. For subjects who are deemed as screening 
failure during the pre-ablation screening, only the following data will be recorded on the eCRF:
•
Informed consent date.
•
Demographic information (age, race, gender, and ethnicity).
•
Reason for screening failure.
2) Visit 2 - Ablation (till discharge)
The ablation procedure (Visit 2A), followed by post ablation observation and discharge (Visit 2B)
1)
Visit 2A- Ablation
The study is performed using the NeuWave Certus microwave ablation system in combination with 
the NeuWave Certus microwave ablation probe by a physician experienced in tumor ablation at the 
study site during the same procedure. During the ablation, subjects will be under an anesthesia as 
per the institution’s SOC.
The inclusion and exclusion criteria should be confirmed again to ensure that the patient 
continued to meet all criteria. Otherwise the patient will be a screen failure case. 
Pain assessment (prior to ablation): using the Numeric Pain Rating Scale (NPRS).
On the day of ablation, the size of tumor to be ablated should be measured and recorded 
(3D) according to the CT image on that day again.
CT-guided ablation procedure: during the ablation procedure, the microwave ablation 
probe is guided to the lung tumor by the lung CT guide, and CT will be used at least at 3 
time points: 
(1) Before probe insertion: before inserting the probe into the tumor, the tumor to be 
ablated and surrounding structures are confirmed by CT. The investigator should record 
whether there are important normal anatomical structures or pathological structural 
changes around the tumor that affect the ablation range or/and safety, and if any, measure 
the shortest distance from this structure to the ablated tumor. 
(2) Before ablation: immediately prior to ablation, confirm that the probe is in the desired 
location using CT. If not in the expected position, reposition the probe and perform 
another scan. The physician should repeat the ablation process until the intended location 
is reached;
(3) During ablation: Using CT to monitor the ablation probe and adjust the ablation time 
and power (this is an optional CT);
(4) Post-ablation: After the ablation is completed, confirm the ablation procedure is 
completed using CT taken approximately 10 minutes after the ablation is completed and 

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determine whether the ablation lesion covers the tumor. If the ablation margin is not 
sufficient (i.e. Did not reach at least 5mm of safety margin for oligometastatic lung tumor
or at least 1cm safety margin for NSCLC), the study physician should repeat the ablation 
to achieve an adequate ablation margin if the situation permits.
Record ablation procedure details, including but not limited to the following:
o
Procedure date and time
o
Mode of anesthesia
o
Guidance method used
o
Anatomic location of ablated tumor
o
Number of ablation cycles
o
Ablation power and time
Device count: all probe types and amounts.
Intra-ablation Screening: For patients who meet the intra ablation exclusion criteria, they 
will be considered an intra-ablation screening failure, and will record:
o
Informed consent date
o
Demographic information (age, race, gender, and ethnicity)
o
Reason for screening failure
Intra-ablation Stopping Criteria and Procedure:
o
During the ablation procedure, if the investigator should stop the procedure after 
probe puncture but before any microwave power emission to the subject’s lung tumor,
due to adverse events like severe bleeding/pneumothorax, or due to any other
presenting conditions, the patient will be withdrawn from the study, recording the 
reason, and receive a follow-up period of 30 days after the procedure from the safety 
evaluation perspective. If the withdrawn subject reports a SAE, the subject will be 
followed until resolution of the event, a stable endpoint is reached, or until the event 
is appropriately explained.
o
For subjects with multiple tumors identified to be ablated during screening, if not all
of the identified tumors receive ablation, the reason(s) for not ablating any of the 
identified tumors will be recorded. The subject will not be withdrawn from study. 
Further treatment on the non-ablated tumors will be based on sites’ SOC (i.e., not 
using the study devices).
The tumors that have been identified to be ablated during screening and receive ablation 
power during the initial ablation procedure will be regarded as “Target Tumor(s)”. Only 
the “Target Tumor(s)” will undergo tumor level effectiveness evaluations (i.e., Technical 

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Success, Technical Efficacy, and Local Tumor Progression).
The investigator should measure and record the maximum diameter and minimum 
diameter of each ablation lesion, as well as the minimum ablation margin (i.e., the 
distance from the edge of ablation lesion to the tumor edge).
Document the investigator's classification for tumor ablation result evaluation:
A0 = Completed ablation procedure protocol with the ablation zone fully covering 
the tumor with an adequate safety margin (i.e., minimum safety margin of at least 
5mm for secondary lung tumors and at least 10mm for primary lung tumors) as
assessed by approximately 10 minutes post-ablation lung CT
A1= Completed ablation procedure protocol with the ablation zone fully covering 
the tumor but with insufficient safety margin (i.e., minimum safety margin less than 
5mm for secondary lung tumors or less than 10mm for primary lung tumors) as
assessed by approximately 10 minutes post-ablation lung CT
A2= Failure to complete the ablation procedure according to the ablation plan, and 
the ablation zone does not completely cover the tumor as assessed by approximately 
10 minutes post-ablation lung CT
NOTE: While Technical Success will be defined as either an A0 or A1 ablation, the goal 
is to achieve A0 ablation, and this will be a pre-specified secondary analysis. For all A1 
and A2 ablation classifications, the investigator will document the reason(s) why a margin 
of 5mm for secondary lung cancer or a margin of 1cm for NSCLC was not attainable on 
the applicable eCRF.
NOTE: If ablation procedure could not be completed after microwave power has started 
emitting, this case will be regarded as A2 ablation. 
All AEs and SAEs.
Relevant 
concomitant 
medication: 
including 
blood 
thinning/anticoagulants,
antineoplastic agents such as chemotherapy/ targeted therapy/ immunotherapy, steroids, 
anti-inflammatories, NSAIDs, antibiotics and medications used to treat relevant medical 
history and adverse events. There is no need to record the anesthetics used during the 

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ablation procedure.
Concomitant procedure: the name, time, site and purpose of the concomitant procedure
(NOTE: There should be no planned concomitant procedure at the time of the ablation
according to exclusion criteria).
The basic tumor information(not include assessment results of investigator) will be jointly provided 
with the CTs to IRC, which includes enhanced CT before ablation, CT before probe insertion, CT 
before ablation, CT during ablation (optional) and CT after ablation, for ablation size measurement, 
ablation margin measurement, determination of immediate ablation results (A0, A1, A2), and 
determination of Technical Success Rate, A0 Ablation Rate.
2)
Visit 2B
The following data will be collected after ablation till discharge:
ECOG performance status score at day 1 after the ablation.
Pain assessment: using the Numeric Pain Rating Scale (NPRS) at day 1 and day 3 after 
the ablation, this can be done by phone as needed.
As clinically necessary, the study doctor can schedule a lung X-ray and/or lung CT scan 
as needed as an optional imaging test (e.g. at 1-3 days post-procedure) for a patient to 
assess the occurrence of post-ablation lung complications.
Length of stay (LOS): the time from ablation completion to discharge is recorded.
Relevant 
concomitant 
medication: 
including 
blood 
thinning/anticoagulants, 
antineoplastic agents such as chemotherapy/ targeted therapy/ immunotherapy, steroids, 
anti-inflammatories, NSAIDs, antibiotics and medications used to treat relevant medical 
history and adverse events. 
Concomitant procedure: the name, time, site and purpose of the concomitant operation 
(including but not limited to puncture, radiotherapy, ablation therapy and surgical 
resection).
All AEs and SAEs.
NOTE: Between post-ablation and Visit 3, if the investigator considers it in the best interest of the 
patient to restart systemic therapy before completing the primary efficacy endpoint assessment 
approximately 30 days after the initial ablation, the investigator should contact the Sponsor medical 
monitor for discussion.
3) Visit 3
One month following the ablation procedure (30 days ± 7 days post procedure), subjects will return 
to the study site for the following evaluations:
ECOG performance status score.

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Pain assessment: using numeric pain rating scale, this can be done by phone as needed.
Quality of Life assessments: the QOL questionnaires include the EORTC QLQ-C30 and 
the lung-specific QLQ-LC13.
Enhanced CT scan of the lung.
Document the investigator's determination of Technical Efficacy evaluation.
Submit the CT images to the IRC for determination of Technical Efficacy evaluation.
Progression at other site to be evaluated by a study physician or may be reported by a 
patient’s primary treating oncologist. If there is a progression, the study physician should 
specify if the progression is a new lung malignant tumor, or a distant metastasis.
Any unplanned hospitalization in any hospital for any reason within 30 days post-ablation 
will be recorded, and the investigator will assess the reason for re-admission and record it 
in the study database.
Relevant concomitant medication: including blood thinning/anticoagulants, antineoplastic 
agents
such as chemotherapy/ targeted therapy/ immunotherapy, steroids, anti-
inflammatories, NSAIDs, antibiotics and medications used to treat relevant medical history 
and adverse events. 
Concomitant procedure: the name, time, site and purpose of the concomitant procedure 
(including but not limited to puncture, radiotherapy, ablation therapy and surgical 
resection).
All AEs and SAEs.
Note: Within the study, re-ablations on the initially ablated target tumor(s) should not be performed 
before the Visit 3 assessment for Technical Efficacy has been completed. If investigators assess it 
is medically indicated/necessary to re-ablate before the Visit 3 Technical Efficacy assessment, the 
re-ablated tumor’s Technical Efficacy assessment will be counted as failure. The re-ablation will 
not change or extend the subject’s follow-up schedule.
4) Visit 4 to visit 6 (end of study)
Visit 4 will occur at 3 months (± 14 days), Visit 5 will occur at 6 months (± 1 month), and Visit 6 
will occur at 12 months (± 1 month) after surgery during which subjects will return to the study site 
for the following assessments:
ECOG performance status score.
Quality of Life questionnaire: the QOL questionnaires include the EORTC QLQ-C30 and 
the lung-specific QLQ-LC13 (Visits 5 and 6 only).
Enhanced CT scan of the lung.
Document the investigator's determination of Local Tumor Progression.

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Submit the CT images to the IRC for determination of whether Local Tumor Progression has 
occurred or not.
Progression at other site to be evaluated by a study physician or may be reported by a patient’s 
primary treating oncologist. If there is a progression, the study physician should specify if the 
progression is a new lung malignant tumor, or a distant metastasis.
Relevant 
concomitant 
medication: 
including 
antineoplastic 
agents 
such 
as 
chemotherapy/targeted therapy/immunotherapy and drugs related to the recorded adverse 
events.
Concomitant procedure: the name, time, site and purpose of the concomitant operation 
(including but not limited to puncture, radiotherapy, ablation therapy and surgical 
resection).
All AEs considered by the investigator as related to the study device or/and study 
procedures and all SAEs.
5) Unscheduled Visits
The following data will be collected at all unscheduled visits:
Reason for the unscheduled visit.
Relevant 
concomitant 
medication: 
Including 
antineoplastic 
agents 
such 
as 
chemotherapy/targeted therapy/immunotherapy and drugs related to the recorded adverse 
events.
Concomitant procedure: the name, time, site and purpose of the concomitant operation 
(including but not limited to puncture, radiotherapy, ablation therapy and surgical 
resection).
All AEs and SAEs.
Any other study assessments, per SOC.
Notes: Re-ablations on the target tumor(s) in the study should only be conducted after finishing 
Visit 3 evaluation.
Re-ablations using the microwave ablation system and ablation probe provided in this study can 
only be performed when there is local progression of lung tumor after initial ablation, or residual 
tumor or insufficient margin during initial ablation of tumor (if considered medically indicated/
necessary by the investigator so as to obtain sufficient ablation margin of tumor). The study device
provided by this study cannot be used for the ablation of other lesion foci.
For each re-ablation using the study device within this study, the following information will be 
captured:
Reason for the re-ablation.

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Record ablation procedure details, including but not limited to the following:
o
Procedure date and time
o
Mode of anesthesia
o
Guidance method used
o
Anatomic location of ablated tumor
o
Number of ablation cycles
o
Ablation power and time
Device count: all probe types and amounts.
Document the investigator's re-ablation result evaluation.
Submit the CT to IRC for re-ablation result evaluation.
All AEs and SAEs.
7.3. Monitoring Plan
This study is conducted in compliance with Good Clinical Practice for Medical Devices and 
relevant international laws, regulations and guidelines, such as ISO 14155.
The sponsor shall undertake monitoring responsibility for the clinical trial, select qualified monitors 
to perform relevant duties, and make sure:
1.
The rights and well-being of the subjects are protected; 
2.
Reported study data is accurate, complete, and verifiable from source documents;
3.
The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), applicable GCPs for medical devices, and applicable regulatory 
requirements. 
Steps to be taken to ensure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate study centers, review of protocol procedures with the Investigator and 
associated personnel prior to the study, and periodic monitoring visits by the Sponsor. The Sponsor 
will verify the authenticity, accuracy, completeness and legibility of the source documents and 
source data as well as the completeness of each subject’s source documents, and review the eCRFs 
for accuracy and completeness during on-site monitoring visits and after their return to the Sponsor; 
any discrepancies will be resolved with the Investigator or designees, as appropriate. The data will 
be entered into the clinical study database and verified for accuracy.
The extent and nature of monitoring will be predetermined and based on considerations such as the 
objective, design, complexity, and endpoints of the study 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 study.

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This study may be subject to inspection by the sponsor or inspection by health authorities. The 
investigator shall agree to and cooperate with the Sponsor or its designated representative and 
regulatory authorities in on-site review and inspection of all study-related documents and subject 
records. By signing the signature page for this protocol, the investigator agrees to allow the sponsor 
or its designated representative and regulatory authorities to monitor all project-related study 
documents on site.
See the attached monitoring plan for details.
8. STATISTICAL CONSIDERATIONS
8.1. Statistical Design, Method and Analysis Procedure
This study is a single-arm, prospective, multi-center clinical study with performance goals.
Categorical variables will be summarized descriptively by frequencies and associated percentages. 
Continuous variables will be summarized descriptively by number of subjects, mean, standard 
deviation, median, quartile, minimum, and maximum. 
All endpoint analyses at the tumor level will be conducted on “Target Tumors” (i.e. tumors 
identified to be ablated during screening and receive ablation power during the initial ablation 
procedure).
The data analysis plan will be documented in detail in the Statistical Analysis Plan (SAP).
Primary Effectiveness Endpoint-Technical Efficacy Rate
The analysis of the primary effectiveness endpoint is to demonstrate the technical effectiveness of 
the NeuWave Certus microwave ablation system and accessories in the ablation of Chinese patients 
with NSCLC or secondary lung cancer. This endpoint will be based on the scan obtained at Visit 3 
and will count as successes when tumors with completely covered ablation zone without 
pathological enhancement as assessed by enhanced CT scan at Visit 3 (i.e., 30 days ± 7 days after 
the first ablation procedure). Additionally, if an initial ablated tumor had re-ablation before the Visit 
3 Technical Efficacy assessment, the re-ablated tumor will be considered a failure. 
The primary endpoint will be assessed based on an independent review committee (IRC)’s
evaluation results using the following methods:
The hypothesis test for Technical Efficacy Rate is null hypothesis (H0)
P0 (80%) vs. alternative 
hypothesis (H1): P > 80%. Wherein, P represents the true technical efficiency for the NeuWave 
Certus Microwave Ablation System and 80% is the Performance Goal (PG). If the lower limit of 
the 95% CI of the Technical Efficacy rate based on the Normal Approximation to the Binomial 
distribution (Z-test that uses S(P0) to estimate the standard deviation) is higher than the predefined 
PG value, primary endpoint success is considered.
PG is determined based on the results of the meta-analysis on the existing literature of similar 
techniques. The Technical Efficacy rate at 1 month after microwave ablation was extracted from 

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existing literature, and then the point estimate and corresponding 95% confidence interval were 
estimated by meta-analysis using random effects. The meta-analysis results showed that, prior 
studies based on a variety of populations have a mean Technical Efficacy rate of 87% (95%CI: 
79%-92%) after MWA of lung cancer at 1 month. Considering that PG is the minimum threshold 
of the acceptable performance, new product-related study curve, clinically significant Technical 
Efficacy rate, and lower limit of the above 95% confidence interval, the PG of the study is set as 
80%. The primary analysis of Technical Efficacy will be performed at the Target Tumor level and
at the subject level on the Full Analysis Set. For multi-target-tumor subjects, the largest Target 
Tumor, determined by the maximum three dimensions of each target tumor, will be used for the 
subject-level analysis. This will be repeated for the Per Protocol Set.
An additional analysis will be conducted based on the investigators evaluation of Technical 
Efficacy Rate.
Secondary endpoints:
1.
The number and percentage of tumors with Technical Success Rate, A0 Ablation Rate,
and Re-ablation Technical Success Rate will be summarized and 95% confidence interval 
will be estimated based on the Normal Approximation to the Binomial distribution.
Technical Success Rate and A0 Ablation Rate will be based on ablation zone tumor 
coverage and the ablation margin achieved after the first ablation and prior to any 
repeat ablations. 
Re-Ablation Technical Success Rate will be based on ablation zone tumor coverage 
and ablation margin achieved after re-ablation.
2.
Local Tumor Progression will be estimated using Kaplan-Meier method and 95% 
confidence interval will be provided.
3.
Progression-Free Survival and Overall Survival will be estimated based on patient level 
using Kaplan-Meier method and 95% confidence interval will be provided.
4.
The summary description of pain scores, ECOG scores and Quality of Life scores will be 
reported based on patient level according to the standard recommended method.
5.
The length of stay as well as the number and percentage of readmissions will be described 
based on the patient level, and the reasons for readmission will be counted and percentage 
will be calculated.
6.
Ablation Procedure Related Indicators will be reported descriptively.
7.
The number and percentage of subjects who complete and do not complete the study and 
the specific reasons for not completing the study will be counted and calculated based on 
the patient level.
Note: Primary and secondary efficacy endpoints related to efficacy that are assessed by both the 
study physician (i.e., PI) and Independent Central Imaging Committee (IRC) as described in 

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Section 7.1, including Technical Efficacy Rate, Technical Success Rate, A0 Ablation Rate, Re-
ablation Technical Success Rate, and Local Tumor Progression will be recorded.
Safety endpoints:
The safety endpoints will be summarized in the safety set, where the safety data of subjects in 
the run-in period can be summarized separately from the rest of subjects. The number and 
percentage of subjects experiencing any adverse event (AE) and serious adverse event (SAE) will 
be summarized at the preferred term level of MedDRA. The severity of AEs and SAEs will be 
summarized. The AEs and SAEs will also be summarized according to the Society of Interventional 
Radiology (SIR) classification. Study device-related AEs, ablation procedure-related AEs, all SAEs, 
device-related SAEs, and ablation procedure-related SAEs will be summarized in a similar way. 
Besides, the incidence of the predefined AEs below will also be summarized and reported:
1.
Pneumothorax (all and those requiring chest tube drainage)
2.
Hemorrhages (all and those requiring treatment)
3.
Post-ablation syndrome
4.
Chest wall pain
5.
Pleural Effusion (all and those requiring chest tube drainage)
6.
Pneumonia
7.
Pulmonary or pleural abscess
8.
Other infections
9.
Bronchopleural fistula
Three analyses in total are planned.
1.
The first analysis will occur after 50% of the target enrolled subjects complete the 1-
month visit, aiming to inspect the assumption used for calculation of sample size and 
determine if the sample size should be increased. In view of the lack of available clinical 
data for evaluating the performance of the study product in percutaneous lung tumor 
ablation procedure, the sample size will be re-estimated adopting a self-adaptive method 
after approximately 50% of the initial planned sample size are enrolled. The sample size 
will be re-estimated based on the assessment of conditional power, so as to increase the 
sample size to the predefined maximum value of 200 subjects or more or maintain the 
originally planned sample size of 120 subjects plus run-in subjects (each site will enroll 
2 run-in subjects). Enrollment in the trial will continue while this interim analysis is being 
conducted. Complete details of the methodology will be provided in the SAP. 
2.
The second analysis will occur after all enrolled subjects finish the 1-month visit, aiming 
to evaluate the Technical Efficacy, periprocedural endpoints and safety of lung tumor 
ablation, and if the primary endpoint success is deemed, the study report will be submitted 

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to NMPA for the registration application of lung ablation indication.
3.
The third analysis will occur after all subjects complete the study.
8.2. Calculation of Sample Size
8.2.1. Total Sample Size
It plans to enroll 120 subjects plus run-in subjects (each site will enroll 2 run-in subjects) in this 
clinical study. The sample size calculation is justified as follows:
The study sample size is determined by hypothesis testing for the comparison of the primary 
endpoint versus the performance goal (PG). PG is determined based on the results of the meta-
analysis on the existing literature of similar techniques. The Technical Efficacy rate at 1 month after 
microwave ablation was extracted from existing literature, and then the point estimate and 
corresponding 95% confidence interval were estimated by meta-analysis using random effects. The 
meta-analysis results showed that, prior studies based on a variety of hypotheses have a mean 
Technical Efficacy rate of 87% (95%CI 79%-92%) at 1 month. Considering that PG is the minimum 
threshold of the acceptable performance, new product-related study learning curve, clinically 
significant Technical Efficacy rate, and lower limit of the above 95% confidence interval, the PG 
of the study is set as 80%.
The Technical Efficacy
P0 (80%) vs. H1: P > 
80%, where P is the actual Technical Efficacy rate of the NeuWave Certus Microwave Ablation 
System. A sample size of 120 subjects is necessary to achieve at least 80% power for demonstrating 
that the Technical Efficacy rate of the NeuWave Certus Microwave Ablation System is > 80% when 
the expected performance is 90% and a one-sided significance level of 0.025 is used with the 
Normal Approximation to the Binomial distribution (Z-test that uses S(P0) to estimate the standard 
deviation), with adjustment for up to 10% dropout. Besides, each site will enroll 2 subjects first in 
the run-in phase. So the total sample size will be 120 subjects plus run-in subjects (each site will 
enroll 2 run-in subjects).
In addition, given the lack of available clinical data for the evaluation of the performance of the 
investigational product in pulmonary tumor ablation procedures, an adaptive approach will be used 
to re-estimate the sample size after enrolling approximately 50% of the originally planned sample 
size. The sample size will be re-estimated based on the assessment of conditional power, so as to 
increase the sample size (the predefined maximum value is 200 subjects) or maintain the originally 
planned sample size of 120 subjects plus run-in subjects(each site will enroll 2 run-in subjects).
8.2.2. Number of Clinical Trials Subjects for Each Disease and Reasons for 
Determination
Each site should at least enroll 2 run-in subjects. No disease type (NSCLC or oligometastatic lung 
tumor) requirement for the run-in phase subjects. Of the 120 non run in sample, the number of cases 
for each disease type is limited at up to 75% (i.e. in the 120 non run in sample, up to 90 subjects

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could be NSCLC or oligometastatic lung tumor).
8.2.3. Significance Level and Power of Clinical Trial
In this study, the statistical power is set as 80% for the sample size calculation of primary 
effectiveness endpoint test, and the significance level of hypothesis test is set as one-sided 0.025. 
8.2.4. Expected Dropout Rate
The expected drop-out rate for this clinical study is 10% at Visit 3.
8.3. Acceptance/Nonacceptance Criteria of Clinical Trial Results
If the lower limit of the 95% confidence interval of the technical response rate of the primary 
endpoint in this study is greater than the pre-specified PG of 80%, the null hypothesis is rejected 
and the alternative hypothesis is accepted, and the clinical trial succeeded.
80% of the pre-set PG, it is considered that the clinical trial failed.
8.4. Criteria and Reason for Terminating the Trial Based on the Statistical Results
There is no planned termination of the trial due to statistical reasons.
8.5. Statistical Method of All Data, together with the Handling Method of Missing, 
Unused and Error Data (including Termination and Withdrawal Halfway) and 
Unreasonable Data
All effectiveness endpoint analyses will be performed only on subjects undergoing ablation with 
the NeuWave Microwave Ablation System and observed data will be analyzed. 
1) In the primary analysis of the primary effectiveness endpoint:
A new subject will be recruited to replace any subject who discontinues the ablation procedure 
after the ablation probe punctures the skin and before the microwave energy is released.
If an initial ablated tumor had re-ablation before the Visit 3 Technical Efficacy assessment, the 
re-ablated tumor will be considered as failure. 
Other subjects with missing parameters or other early discontinuations will not have data 
imputation.
2) A sensitivity analyses will also be performed for the primary effectiveness endpoint after missing 
data are imputed according to the following methods:
A new subject will be recruited to replace any subject who discontinues the ablation procedure 
after the ablation needle punctures the skin and before the microwave energy is released.
If an initial ablated tumor had re-ablation before the Visit 3 Technical Efficacy assessment, the 
re-ablated tumor will be considered as failure.
As a conservative surrogate endpoint, if the subject does not have Visit 3, then chest enhanced 

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CT at Visit 4 will be sent to the IRC for local tumor progression assessment, and if local tumor 
progression occurs, the primary effectiveness endpoint at Visit 3 will be imputed as a failure.
If there is no local tumor progression at Visit 4, the primary effectiveness endpoint at Visit 3 
will be imputed as successful. If a subject does not have both Visit 3 and Visit 4, the subject 
will be excluded from the analysis of the primary effectiveness endpoint.
For secondary endpoint missing value, there will be no imputation. The handling methods for 
missing values and outliers are detailed in the Statistical Analysis Plan (SAP).
8.6. Procedures for Reporting Deviations from the Original Statistical Plan
Any major changes to the SAP should be described and justified in an amendment to the SAP and/or 
in the final report.
8.7. Selection Criteria and Rationale for Subjects Included in the Analysis
All subjects who met the inclusion and exclusion criteria are considered to meet the recruitment 
requirements.
The primary analysis of safety and effectiveness endpoints will be performed on the Full Analysis 
Set. Primary Effectiveness endpoint analyses will be repeated for the Per Protocol Set. The Safety 
Set will only be used for summarization of safety endpoints. Safety and effectiveness data collected 
on patients participating in the run-in phase may be summarized separately from the remaining 
patients. 
Subgroup analysis will be conducted as needed and will be described in the SAP.
The analysis sets in this study are defined as follows: 
8.7.1. Full Analysis Set
The full analysis set (FAS) set is defined as all patients that are included in the study, do not enter 
the run-in period and received ablation power.
8.7.2. Per-Protocol Set
The per protocol (PP) set is defined as patients in the full analysis (FAS) set without major protocol 
deviations that have great impact on the primary effectiveness endpoint.
8.7.3. Safety Set
Safety set (SAF) includes all subjects who provide informed consent and have microwave ablation 
attempted with the NeuWave system and includes the run-in phase patients.
9. DATA MANAGEMENT
The individual patient data collected during the period of this trial will be recorded in the 
corresponding study database. The captured data will be reviewed by the data management team 
and other applicable Sponsor study team members. Any unexpected or missing data points will 
generate a query for the site to assess and resolve. Sponsor provided monitors will be available for 

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questions and follow-up with the sites, as needed.
When all subjects complete all follow-up evaluations and the corresponding data is entered, this 
study will be closed. Data analysis will be performed following database lock.
10. FEASIBILITY ANALYSIS
10.1. Analysis on the Possibility of Success
Pre-clinical and clinical data has shown that MW ablation is safe and effective in small lung tumors 
with low complication rates, high rates of Technical Success, low rates of Local Tumor Progression.
In terms of clinical results of thermal ablation therapy for primary lung cancer, the OS of thermal 
ablation therapy is approximately 86% at 1 year and 69% at 2 years15,16. Regarding the use of 
thermal ablation for the treatment of secondary lung cancer, a prospective observational study 
found that for small secondary lung cancers, reuse of thermal ablation resulted in a survival benefit 
similar to surgical resection. This includes 566 patients with a total of 1037 secondary lung tumors. 
By controlling the lung tumors with repeated thermal ablation during the follow-up period, the OS 
of this population is 62 months, the 5-year survival rate is 51.5%, and the 4-year local treatment 
effectiveness is 89%21.
The Certus Microwave Ablation System and Accessories have been cleared by the United States 
(US) Food and Drug Administration (FDA) and has been in clinical use since 2011 in the United 
States. The growing popularity of the Certus Microwave Ablation System in lung cancer ablation 
therapy result from its low risks of complications and high effectiveness in ablating lesions of the 
lung. The published clinical data on Certus lung ablation is limited. But from previous data, there 
is a high likelihood of meeting the protocol Technical Efficacy goal and previous major 
complications rate was low, which is unlikely to cause discontinuing of the study due to safety 
concerns.
The study device is provided free of charge and does not increase the burden on subjects, so the 
recruiting and screening of subjects will not be fairly difficult. Patients need to return to their study 
site for continued follow-up, a total of 4 times, lasting for 1 year, which is in line with the frequency 
of clinical routine visits after lung cancer ablation. So it will not be too difficult to obtain the results 
of the visits required for the study.
10.2. Feasibility analysis of Failure
As mentioned earlier, although the investigational product is a mature ablation product for lung 
tumors, the amount of relevant clinical literature published is small, and there may be some 
unidentified problems, resulting in some unanticipated problems in this study.
Because this study limits the inclusion and exclusion criteria for the included lung cancer lesions, 
there is a risk that 120 patients could not be completed within the planned time of the study.
In addition, the study requires that subjects return to the hospital for visits at 4 follow-up points 
within 1 year after the completion of ablation and discharge, which may cause some subjects to be 

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lost to follow-up. Although with full informed consent, this situation may not be completely 
avoided. The total sample size has considered a 10% drop-out rate at postoperative 1 month.
11. QUALITY CONTROL OF CLINICAL TRIAL
During the clinical study, the sponsor and investigators shall fulfill their respective responsibilities 
in accordance with the Good Clinical Practice for Medical Devices (No. 25) and applicable Chinese 
and international regulations, and strictly follow the clinical trial protocol to ensure the quality of 
clinical trials.
The sponsor should, in accordance with the requirements of the clinical trial protocol, organize the 
training on the clinical trial protocol and the use and maintenance of the investigational product for 
all the investigators participating in the trial to ensure the consistency in the implementation of the 
clinical trial protocol and the use of the investigational product.
During the implementation of the study, the sponsor is responsible for monitoring each phase of 
the clinical trial. The clinical research associate designated by the sponsor or the designated 
representative should follow the relevant SOP and clinical trial protocol formulated by the sponsor 
to monitor the clinical trial so as to ensure that the data are complete, accurate, true and reliable.
In order to ensure the quality of the study, the sponsor may entrust a qualified quality control or 
auditor to audit the clinical trial as needed. After receiving the notice, the investigator shall allow 
the auditor to view the original data and documents related to the study.
When administration departments send the inspection personnel to carry out the inspection, the 
clinical trial institution and Investigator should cooperate and immediately notify the Sponsor.
12. ETHICAL ISSUES AND INFORMED CONSENT OF CLINICAL TRIAL
12.1. Ethical Considerations
Comply with Chinese laws and regulations, Helsinki Declaration and other international consensus 
to protect the rights, safety and health of subjects, including:
1)
Ensure that the subjects are fully informed and agree to voluntarily participate in this 
study;
2)
Respect and protect the privacy of the subjects, and keep confidential the information that 
may identify the subjects;
3)
The production of investigational medical devices shall meet the relevant requirements 
of the applicable medical device quality management system; the use of test medical 
devices and control products shall comply with the requirements of instructions, schemes 
and relevant operating guidelines;
4)
Select qualified clinical sites and investigators;
5)
The subject has the right to withdraw from the study at any time and for any reason 
without prejudice to the future medical care provided to them by the physician or the 

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institution;
6)
Protocol and amendments, ICF and amendments and other applicable documents related 
to the study should not be implemented before obtaining the written approval from the 
Ethics Committee.
12.2. Review and Approval of Trial Protocol
The trial protocol should be internally approved and filed according to the company’s SOP prior to 
submitting to the external agency (including but not limited to the government regulatory agencies, 
Ethics Committee).
The clinical trial protocol should not be implemented until the written approval is obtained from 
the Ethics Committee according to the relevant requirements of laws and regulations.
12.3. Process of Informed Consent and Text of Informed Consent Form
12.3.1. Process of Informed Consent
The informed consent of all potential patients must be obtained prior to performing any study 
tests/procedures that are not SOC. Once the investigator determines that the patients are suitable 
for participating in this study, the investigator must explain the background of the study presented 
and the benefits and risks of surgery and study to the patients and answer the questions raised by 
patients. Only the patient who signs the informed consent form that is approved by the EC prior to 
participating in the study is eligible to participate in this study.
Each patient (or legally authorized representative) must sign and date the informed consent form 
that is approved by the EC (and other documents as per local regulations) prior to implementing 
any study-related items or operations not belonging to the SOC and after the nature of this study is 
fully explained.
The process of obtaining the written informed consent needs to prove that the subjects volunteer to 
participate in this study. All aspects of this study must be clarified to the subjects prior to signing 
the informed consent form. The process of obtaining the informed consent must be clearly 
documented by the investigator and/or designated person in the original clinical trial documents of 
subjects. The investigator has responsibilities to ensure the process of obtaining the informed 
consent is implemented according to the Good Clinical Practice for Medical Device Trials and 
related regulations, such as ISO 14155, the Declaration of Helsinki.
12.3.2. Text of Informed Consent Form
See the attached ICF.
13. DEVICE MANAGEMENT
In this study, the sponsor will supply all study products. All devices clearly labeled as "For Study 
Only" on the packaging must be stored according to the product labeling and IFU conditions. It is 
the responsibility of the Principal Investigator to ensure that devices are stored correctly at the sites.

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The Principal Investigator or responsible person designated by the Principal Investigator must 
account for all study devices throughout and, at the end of, the clinical study. During the entire 
course of the study, the study ablation probes must be stored in a locked or secure access location. 
An inventory record must be maintained of all devices received, used or returned during the clinical 
trial. Details of the product code and lot numbers must be documented in the CRF as well as the 
patient’s hospital notes. The Principal Investigator must allow the Monitor access to the secure 
facility where the study devices are stored during the clinical trial to check inventory. At the end of 
the clinical trial all machine and all unused probes must be returned to Johnson & Johnson Medical 
(Shanghai) Ltd. with the appropriate study device return form.
13.1. Packaging and Labeling of Study Device
All study devices provided by the sponsor in this study will be prepared, packaged, and labeled 
under the responsibility of qualified personnel or sponsor's designee in accordance with the 
company's SOPs, Good Manufacturing Practice (GMP) guidelines, and applicable local 
laws/regulations.
Each device is labeled in accordance with regulatory agency guidelines, GMPs, local laws and 
regulations, and company SOPs to identify investigational product for clinical trial use only. 
13.2. Shipping of Study Device
The sponsor or sponsor's designee will ship the device to the study site under the device shipping 
conditions specified in the device's instructions.
13.3. Management of Study Device
The sponsor will be responsible for supplying qualified study products to the site. Each site will
designate study personnel to be responsible for the management of the study device. During the 
entire course of the study, the study ablation probes must be stored in a locked or secure access 
location. The investigator should ensure that all investigational medical devices are only used for 
the subjects of the clinical trial. Details of the product code and lot numbers must be documented 
in the CRF as well as the patient’s hospital record.
Records related to the receipt, distribution, use, recovery and disposal of investigational products 
shall be maintained in accordance with GCP requirements. Upon receipt of the investigational 
product at the site, the investigational product must be reconciled and packaged in the correct 
quantity and under the appropriate shipping conditions. During the study, a designated person will 
be responsible for recording and counting the use of the study product.
The Principal Investigator must allow the Monitor access to the secure facility where the study 
devices are stored during the clinical trial to check inventory. The responsible monitor will review 
the investigational device accountability as applicable. At the end of the clinical trial all machine 
and all unused study devices must be returned to Johnson & Johnson Medical (Shanghai) Ltd. with 
the appropriate study device return form.

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13.4. Return and Destruction of Study Device 
All machine, unused, opened, unused, damaged, mislabeled, or malfunctioning study devices will 
be returned to the Sponsor's designated address. Complete the appropriate form to properly return 
the device to the sponsor's specified address.
14. REGULATIONS OF ADVERSE EVENT AND DEVICE COMPLAINT 
REPORTING
14.1. Adverse events
An adverse event refers to any detrimental medical events in the course of a clinical trial, whether 
or not related to the investigational medical device.
From the time of signing the informed consent form until approximately 30 days (Visit 3) after 
ablation (including primary and repeat ablation) or early discontinuation, all adverse events will be 
recorded. During this period, all adverse events from the start of ablation (i.e., probe puncture on 
the skin) will be reported.
After approximately 30 days (Visit 3) post ablation, adverse events considered by the investigator 
as related to the study device or/and study procedures and all serious adverse events will be 
recorded and reported till the end of the study or early discontinuation.
The investigator will determine whether AEs have occurred and determine the relationship of these 
events to the study device or ablation procedure at each evaluation for subjects enrolled in the 
clinical study. 
All AEs must be recorded in the original records and entered in the e-CRF. All AEs need to be 
recorded in the Electronic Data Capture (EDC) system (also called study database) within 2 weeks 
of site awareness.
The following guideline should be used to determine the severity of each AE:
AE severity grading criteria:
Mild
Awareness of sign or symptom that does not interfere with the subject’s usual 
activity or is transient, resolved without treatment and with no sequelae
Moderate
Interferes, but does not hinder, the subject’s usual activity and may require 
treatment
Severe
Symptoms causing severe discomfort, substantial impact on subject's usual 
activities, treatment or intervention required
The AEs should be classified according to the SIR classifications:
Category
Definitions
Mild complications

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A
No intervention, no adverse consequences
B
Nominal treatment, no adverse consequences; including stay for observation
Severe complications
C
Treatment required, short-term hospitalization (< 48 hours)
D
Severe treatment required, increased need for care level, prolonged 
hospitalization (> 48 hours)
E
Permanent adverse sequelae
F
Dead
It is the investigator’s responsibility to assess the relationship between all AEs and the study 
procedure. The following guidelines should be used in determining the relationship of an AE to a 
device, study procedure, or other causality:
Not Related:
Relationship to the procedure 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

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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.
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 
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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.
14.2. Serious Adverse Event
It is the investigator’s responsibility to determine the “seriousness” of an AE using the protocol 
defined terms below. All SAEs need to be recorded in the Electronic Data Capture (EDC) system 
(also called study database) within 24 hours of site awareness. An SAE is an AE that results in one 
or more of the following for this study: 
•
Resulted in death: An AE that resulted in the patient’s death. 
•
Life-threatening illness or injury: The patient is at imminent risk of dying at the time of 
the AE. 
•
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. Note: If a patient has prolonged 
hospitalization due to having an additional ablative procedure and with no other adverse 
event, this should not be considered an SAE. 
•
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. 
•
A persistent or significant disability or incapacity. 
Notes: 
1. Progression of the disease under investigation should not be reported as an SAE. 
2. “Death” should not be reported as an SAE. The cause of death, however, should be reported 
as an SAE, except for progressive disease. 
3. Planned hospitalization for a pre-existing condition, but without serious deterioration in 

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health, is not considered a serious adverse event. 
4. A procedure required by the protocol is not considered an SAE unless the patient experiences 
a serious deterioration in health or hospitalization is prolonged. 
14.3. Device Complaints
A device complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a 
product after it is released for distribution. Any device complaint must be notified to the monitor 
by the study site and tracked and reported according to the procedures specified by the sponsor. 
The monitor will track and report in time according to the methods specified by the sponsor and 
Chinese regulations and return relevant products (as required) to the quality department of 
JJMS/Johnson & Johnson Medical (China) Ltd. (JJMC) according to the sponsor's requirements.
14.4. Device Deficiencies
Device defects refer to unreasonable risks that may endanger human health and life safety during 
medical use in the process of clinical trials, such as label errors, quality issues, and malfunction. 
For equipment defects that may result in SAE, the sponsor shall report to the food and drug 
regulatory authority for registration and the health and family planning department at the same 
level within 5 working days after the knowledge. Meanwhile, it shall notify other clinical trial 
institutions and investigators participating in the trial and promptly advise the ethics committees of 
relevant clinical trial institutions via its medical device clinical trial management department. The 
investigator should record all AEs occurring and device deficiencies found in the process of clinical 
trial, work with the Sponsor to analyze the causes of the events, generate the written analysis report, 
present the comments on the continuation, discontinuation or termination of the trial, and report to 
the Ethics Committee by the administrative department for clinical trial of medical device of 
clinical trial institution for review.  
14.5. Reporting Procedure, Contact Person Information
The investigator should provide the sufficient treatment for any AE of any subjects, including the 
laboratory detection value with clinical significance whether or not it is related to this study. 
From signing the ICF, all AEs related to the patient’s participation in this study should be followed 
up until the event is resolved, or if the event causes the permanent damage, it should be followed 
up until the event is stable and the clinical outcome is determined. If the event is not resolved or 
stable at the end of study, the medical monitor in this clinical study will decide whether it is 
necessary to collect further follow-up information.
All AEs and SAEs that occur within the period from Visit 2A (day of ablation) to Visit 3 (about one 
month after ablation) will be reported; from Visit 3 to through the end of the study, all SAEs, and 
AEs assessed as related to the study device/ablation procedure by the investigator will be reported. 
All AEs should be followed up, until the AE is resolved, stable or the study is completed. 

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The investigator should record the nature, severity, treatment and outcome of an SAE, and 
determine whether it is related to the study device or ablation procedure. The investigator will report 
all AEs to the Sponsor via the study database EDC. 
The investigator must submit any SAEs that occurred in the study and the device deficiencies that 
may cause an SAE, to the Sponsor and National Medical Products Administration (NMPA) (or 
designated person) immediately after being informed of the event. If required by the Sponsor, the 
further information should be provided. 
The investigator and Sponsor should report the SAEs which occurred in the study, and the device 
deficiencies that may cause an SAE, to the regulatory authorities at every level according to the 
requirements of laws and regulations. 
For all SAEs and device deficiencies that may cause SAEs, the Sponsor should report to the Food 
and Drug Administration where the clinical study was filed and the competent department of health 
and Family Planning Commission within 5 workdays after awareness. The Sponsor should also 
inform other clinical trial institutions/sites and investigators that participate in the trial and inform 
the Ethics Committees by their medical device clinical trial management departments in a timely 
manner. 
The study device with a device complaint should be returned to the Sponsor according to the 
instructions given in Section 13 of this study protocol. Once a device complaint is found, the site 
should inform the Sponsor as soon as possible, and report the device related information on the 
relevant CRF. 
Refer to Section 14.3 for details of the device complaint report process. The contacts to report SAEs 
and device complaints are as follows: 
Adverse events 
China AE reporting:
China_CT_Safety@its.jnj.com
Global AE reporting:
ETHMedAlerts@its.jnj.com 
Medical device complaints 
Local CHU reporting: ChinaCustomerQuality-CS@its.jnj.com 
Global CHU reporting: Productcomplaint1@its.jnj.com
15. REGULATIONS ON CLINICAL TRIAL PROTOCOL DEVIATIONS AND 
CLINICAL TRIAL PROTOCOL AMENDMENT
Study protocol deviation refers to a case where the requirements of the Clinical Trial Protocol are 
not followed intentionally or unintentionally. 
All protocol deviations should be reported to the sponsor as protocol deviations, and all protocol 
deviations should be reported in the protocol deviation form and monitoring report, including the 
date and reason of protocol deviation. The investigator should also report the protocol deviation to 

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the hospital's medical device clinical trial management department according to the hospital's 
procedures and regulations, and report to EC through the department. 
If a protocol amendment occurs, the Sponsor or designated person should submit a summary of 
changes of the study protocol to the Investigator, regulatory authority, and the Ethics Committee, 
etc. according to the relevant laws and regulations. All significant amendments must be approved 
by the EC and regulatory authorities (if required) prior to implementation of any changes to study 
procedures. 
An amendment is regarded substantial when they are likely to have a significant impact on: 
• The safety or physical or mental integrity of the subjects; 
• Scientific value of trial; 
• Conduct or management of the trial; 
• Quality or safety of investigational medical device specified in the trial.
16. DIRECT ACCESS TO SOURCE DATA AND DOCUMENTS
Source data refers to the original records of clinical findings, observations and other activities 
during clinical trials, as well as all information in their approved copies, which can be used for 
clinical trial redesign and evaluation. A source document is a printed, paper or electronic file 
containing source data, among others.
The investigator should maintain and retain information in the subject's medical records and other 
study-related documents (source documents). The Investigator should allow the monitors and 
auditors/inspectors to review the following information, including but not limited to:
Confirm the medical history/physical condition of the study subject who meets the 
inclusion criteria of the study protocol before participating in this study;
Medical record documenting the informed consent process;
Description of operation of investigational product;
All inspection results and follow-up;
Dated and signed inspection printouts or reports;
Description of AE and follow-up of AE (event description, severity, onset date, duration, 
correlation with the study device, study procedures, outcome and treatment of AE, 
concomitant medication/procedure when AE occurs);
Description of the device defects
Conditions of study subjects when they complete the study or withdraw from the study.
Appropriate source documents must be available for reviewing during the monitoring visit. The 
Sponsor expects that the study coordinator and/or investigator will also be available for questions 
during monitoring visits.

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17. FINANCES AND INSURANCE
See the relevant study contract and insurance documents.
18. CONTENTS TO BE COVERED IN THE CLINICAL TRIAL PROTOCOL
According to regulatory requirements, the clinical trial report will include the following contents:
The clinical trial report shall be consistent with the protocol, mainly including:
1)
General Information;
2)
SYNOPSIS;
3)
Introduction;
4)
Objective of Clinical Trial
5)
Clinical Trial Method;
6)
Contents of Clinical Trial;
7)
General Data of Clinical Trial;
8)
Diagnosis and treatment methods of investigational medical devices;
9)
Statistical analysis methods and evaluation methods adopted;
10)
Clinical Evaluation Criteria;
11)
The organizational structure of clinical trial;
12)
Ethical description;
13)
Results of the clinical trial;
14)
Adverse events found in clinical trial and corresponding treatment;
15)
Analysis and discussion of clinical trial results, especially indications, scope of application, 
contraindications and precautions;
16)
Clinical trial conclusion;
17)
Problems in existence and suggestions for improvement;
18)
List of study personnel;
19)
Other Situations to be Explained;
20)
Clinical trial summary of each sub-site.
19. PRINCIPLES OF CONFIDENTIALITY
The personal data of subjects participating in the trial shall be kept confidential. However, the 
Ethics Committee, the sponsor, the health regulatory authorities and their authorized 
representatives may review the personal data of subjects participating in the trial according to the 
specified procedures.

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Subject confidentiality will be maintained throughout the clinical study in a way that ensures the 
information can always be tracked back to the source data. For this purpose, a unique subject 
identification code (site number and subject number) will be used to identify all data reported for 
each subject. So long as the data is kept strictly confidential and that the privacy of the subject is 
ensured to be protected, the data related to this study may be available to third parties (for example, 
under the audit of regulatory authority).
20. CONVENTION ON PUBLICATION OF TRIAL RESULTS
At the end of the study, a multicenter clinical trial manuscript will be prepared and 
published in a reputable scientific journal as needed. The publication of the principal results 
from any single-site experience within the study is not allowed until the preparation and 
publication of the multi-center trial results. Exceptions, such as pre-specified and non-pre-
specified analyses of other endpoints, or such secondary analyses and proposed additional 
investigational studies, require prior approval by the sponsor. For purposes of timely 
abstract presentation and publication, secondary publications will be delegated to the 
appropriate principal authors, and final analyses and manuscript review for all multi-center 
trial data will require the approval of the sponsor.
21. RESPONSIBILITIES UNDERTAKEN BY DIFFERENT PARTIES
21.1. Responsibilities of the Sponsor
1) The Sponsor is responsible for the initiation, application, organization and monitoring of clinical 
trial. 
2) The Sponsor is responsible for the organization to establish and modify the investigator’s 
brochure, clinical trial protocol, informed consent form, Case Report Form, relevant standard 
operating procedure and other relevant documents, carry out the training required for the clinical 
trial, and provide these documents to the investigators before the study starts. 
3) The Sponsor should select the qualified trial institution and investigators. 
4) The Sponsor should sign a written agreement with the clinical trial institution and the investigator 
regarding the clinical trial. 
5) The Sponsor should provide qualified study product according to the regulatory requirements. 
The Sponsor should be responsible for the safety of investigational medical device in the clinical 
trial. The AE, SAE, and the device complaint that may cause an SAE should be collected and 
reported in accordance with the provisions. 
6) The Sponsor should inform the regulatory authority at every level when the Sponsor decides to 
suspend or terminate the clinical trial or at the end of the study. 
7) The Sponsor should ensure the investigator conducts the study strictly in compliance with the 
clinical trial protocol, corrects the protocol deviations in a timely way, and reserves the rights to 

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report, to the regulatory authority, any of issues related to this. 
8) The Sponsor should bear the treatment cost and relevant economic compensation for the clinical 
trial-related injury or death of subjects, except for damages due to the fault of medical institution 
and medical staff in the diagnosis and treatment. 
9) The Sponsor should select qualified monitors for monitoring and organizing any inspections, as 
appropriate.
21.2. Responsibilities of Clinical Trial Institution and Investigator
1) The clinical trial institution should evaluate the relevant resources according to the features of 
investigational medical device prior to the clinical trial, to decide whether to participate in this 
clinical trial. 
2) The clinical trial institution should properly keep the records and documents of clinical trial 
according to the agreement with the Sponsor. 
3) Make sure that the investigators responsible for the clinical trial have the qualification in
accordance with the requirements of related laws and regulations. 
4) The administrative department of the clinical trial institution conducting the medical device 
clinical trial should cooperate with the Sponsor to apply to the Ethics Committee and submit the 
relevant documents prior to the clinical trial according to requirements.
5) The investigator should ensure that the relevant workers participating in the trial have the enough 
resources and proper training and keep the training related documents. 
6) The investigator should ensure to use the investigational medical device only for the subjects of 
this clinical trial. 
7) The investigator may not charge subjects any fees for participating in the study. 
8) The investigator should strictly follow the clinical trial protocol, with the exception of emergency 
circumstances when the patient faces the direct risk and needs immediate clinical measures, which 
can be reported later in a written form. 
9) The investigator is responsible for recruiting the subjects, communicating with the patient or its 
legal representative before signing the informed consent. 
10) The investigator should protect the rights, safety and health of the subjects.
11) In case of an AE occurring in the clinical trial, the investigator should protect the safety of the 
subjects and timely report the event to the regulatory authority.
12) The investigator should record all AEs occurring and device deficiencies found in the process 
of clinical trial, work with the Sponsor to analyze the causes of the events, generate the written 
analysis report, present the comments on the continuation, discontinuation or termination of the 
trial, and report to the Ethics Committee by the administrative department for clinical trial of 

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medical device of clinical trial institution for review. 
13) The investigator should make sure that the clinical trial data is accurately, completely, clearly 
and timely recorded in the Case Report Form. 
14) The clinical trial institution and investigator should make sure that the data, documents and 
records generated in the clinical trial are timely, true, accurate, clear, and attributable. 
15) The clinical trial institution and investigator should accept and cooperate with the monitoring 
and audit of the Sponsor, the supervision of the Ethics Committee, and the inspection of the Food 
and Drug Administration, competent department of health and family planning, etc., and provide 
all required records related to the trial. 
16) If the clinical trial needs to be suspended or terminated, the subjects should be informed 
accordingly. It should be ensured that the subjects receive the proper care and follow-up. The 
clinical trial institution and investigator should also report this in accordance with the regulations 
and provide a detailed written explanation. The relevant report should be submitted to the local 
Food and Drug Administration at the provincial, autonomous regional and municipal level, if 
necessary. 
17) The clinical trial institution and investigator reserve the rights to report to the regulatory 
authority at every level when the Sponsor violates relevant laws and regulations.
18) The investigator should complete all records and reports at the end of clinical trial. The 
investigator should also ensure that the received investigational medical devices are properly 
handled and recorded according to the requirements.
21.3. Responsibilities of Other Interested Parties 
See the study related contract, which is available as a separate attachment. 

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STATEMENT OF INVESTIGATOR
I agree to:
1.
Conduct this clinical trial in strict accordance with the requirements of the 
Declaration of Helsinki, China's current laws and regulations and trial protocol.
2.
Record all required data correctly in the study EDC database and input, review, 
and approve the clinical trial report on schedule.
3.
Use the investigational medical device only for this clinical trial, accurately and 
completely record the investigational medical device receipt and use condition 
during the clinical trial and keep these records for review.
4.
Allow the monitor and inspectors authorized and dispatched by the Sponsor and 
regulatory authority to monitor, inspect and audit this clinical trial.
5.
Strictly implement the terms in the clinical trial contract/protocol signed by all 
parties.
I have read thoroughly the clinical trial protocol, including the above statements, and I 
agree to all the above contents
Comments of Sponsor  
Signature (stamp) 
               Day  Month  Year
Comments of investigator
Signature
               Day  Month  Year 
Comments of clinical trial institution of medical device    
               
Signature (stamp) 
                Day  Month  Year  

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APPENDIX 1: STUDY DEVICES CODE LIST
Investigation Product
Model
Description
NWC2CN1N
NeuWave CertusTM Microwave Ablation System
CTBKT1
CT Bed Rail PDM Mounting Bracket, Standard (Applicable to GE, 
Philips)
CTBKT2
CT Bed Rail PDM Mounting Bracket, D68 X W585 Standard 
(Applicable to Siemens)
CTBKT3
CT Bed Rail PDM Mounting Bracket, D48 X W656 Standard 
(Applicable to Toshiba)
CTBKT4
CT Bed Rail PDM Mounting Bracket, D88 X W645 (Siemens Alt)
CTBKT5
CT Bed Rail Mount, Flat
LN15CN
NEUWAVE CERTUS LN Probe 15CM 17ga
LN20CN
NEUWAVE CERTUS LN Probe 20CM 17ga
LK15CN
NEUWAVE CERTUS LK Probe 15CM 17ga
LK20CN
NEUWAVE CERTUS LK Probe 20CM 17ga
LK15XTCN
NEUWAVE CERTUS LK XT Probe 15CM 15ga
LK20XTCN
NEUWAVE CERTUS LK XT Probe 20CM 15ga
PR15CN
NEUWAVE CERTUS PR Probe 15CM 17ga
PR20CN
NEUWAVE CERTUS PR Probe 20CM 17ga
PR15XTCN
NEUWAVE CERTUS PR XT Probe 15CM 15ga
PR20XTCN
NEUWAVE CERTUS PR XT Probe 20CM 15ga
NOTE: These are collectively described as "study devices.”

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