A Single-Arm, Prospective, Multicenter Study to Evaluate the Safety and Effectiveness of the NeuWave Certus Microwave Ablation System in Chinese Patients With Hepatocellular Carcinoma
Phase: NA
Conditions: Liver Tumor, Hepatocellular Carcinoma
Sponsor: Ethicon, Inc.



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TABLE OF CONTENTS 
SYNOPSIS ................................................................................................................ 6 
GLOSSARY............................................................................................................. 16 
1. SPONSOR INFORMATION.............................................................................. 18 
2. LIST OF CLINICAL TRIAL INSTITUTIONS AND INVESTIGATORS ........... 19 
3. OBJECTIVE AND CONTENTS OF CLINICAL TRIAL ................................... 20 
3.1. Objective of Clinical Trial ....................................................................... 20 
3.2. Contents of Clinical Trial........................................................................ 20 
4. BACKGROUND INFORMATION OF CLINICAL TRIAL ................................ 20 
4.1. Introduction to the Condition ................................................................. 20 
4.1.1. Explanation for the Condition ................................................... 20 
4.1.2. Therapeutic Option and Prognosis ...................................... 22 
4.2. Application of Investigational Product ................................................... 23 
4.3. Product Registration and Reason for Clinical Trial Registration in 
China....................................................................................................... 23 
5. FEATURES, STRUCTURAL COMPOSITION, OPERATION PRINCIPLE, 
MECHANISM OF ACTION, AND STUDY POPULATION ................................... 24 
5.1. Features.................................................................................................. 24 
5.1.1. Design Features of Study Product ........................................... 24 
5.2. Study Population .................................................................................... 24 
6. INDICATIONS AND CONTRAINDICATIONS, PRECAUTIONS ................... 24 
6.1. Indications .............................................................................................. 24 
6.2. Contraindications ................................................................................... 25 
6.3. Precautions............................................................................................. 25 
7. OVERALL DESIGN........................................................................................... 26 
7.1. Trial Design ............................................................................................ 26 
7.1.1. Trial Objective ........................................................................... 26 
7.1.2. Trial Endpoints .......................................................................... 26 
7.1.3. Trial Method Selection and Its Rationale ................................. 27 
7.1.4. Measures to Reduce and Avoid Bias....................................... 27 
7.1.5. Selection of Patients ................................................................. 28 
1) 
Inclusion criteria ........................................................................ 28 
2) 
Exclusion criteria ....................................................................... 28 
7.1.6. Efficacy Evaluation Method ...................................................... 31 
7.1.7. Safety Evaluation Method......................................................... 31 
7.2. Study Process ........................................................................................ 32 
7.2.1. Study Flowchart ........................................................................ 32 
7.2.2. Procedure Description .............................................................. 32 
7.2.3. Standard Operating Procedures of Medical Device................ 33 

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7.2.4.
Study Procedures...................................................................... 36
7.3. Monitoring Plan ...................................................................................... 40 
8. STATISTICAL CONSIDERATIONS ................................................................ 40 
8.1. Statistical Design, Method and Analysis Procedure ............................ 40 
8.2. Calculation of Sample Size.................................................................... 42 
8.2.1. Total Sample Size ..................................................................... 42 
8.2.2. Minimum and Maximum Number of Patients in Each Clinical 
Trial Institution and Reasons for Determination................................... 42
8.3. Expected Dropout Rate ......................................................................... 42 
8.4. Criterion of Acceptability/Unacceptability of Clinical Trial Result ........ 42 
8.5. Criteria and Reason for Terminating the Trial based on the Statistical 
Results .................................................................................................... 43 
8.6. Statistical Method of All Data, together with the Handling Method of 
Missing, Unused and Error Data (including Termination and 
Withdrawal Halfway) and Unreasonable Data...................................... 43 
8.7. Reporting Procedure of Deviation from Original Statistical Plan ......... 43 
8.8. Selection Criteria and Reason of Patients Included in the Analysis ... 43 
9. DATA MANAGEMENT ..................................................................................... 43 
10. FEASIBILITY ANALYSIS ................................................................................. 43 
10.1. Likelihood Analysis of Success ............................................................. 43 
10.2. Likelihood Analysis of Failure ................................................................ 44 
11. DEVICE MANAGEMENT.................................................................................. 44 
13. CLINICAL TRIAL ETHICAL ISSUES AND INFORMED CONSENT............. 45 
13.1. Ethical Concerns .................................................................................... 45 
13.2. Approval of Trial Protocol ...................................................................... 46 
13.3. Process of Informed Consent and Text of Informed Consent Form ... 46 
13.3.1. Process of Informed Consent ................................................... 46 
13.3.2. Text of Informed Consent Form ............................................... 47 
14. REGULATIONS OF ADVERSE EVENT AND DEVICE COMPLAINT 
REPORTING ........................................................................................................... 47 
14.1. Adverse event ........................................................................................ 47 
14.2. Serious Adverse Event .......................................................................... 49 
14.3. Device Complaints ................................................................................. 50 
14.4. Reporting Procedure, Contact Information ........................................... 51 
15. DEVIATION FROM CLINICAL TRIAL PROTOCOL AND REGULATIONS 
FOR CLINICAL TRIAL PROTOCOL AMENDMENT ........................................... 53 
16. DIRECT ACCESS TO SOURCE DATA AND DOCUMENT........................... 53 
17. FINANCES AND INSURANCE ........................................................................ 54 
18. CONFIDENTIALITY .......................................................................................... 54 

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19. AGREEMENT ON THE PUBLICATION OF TRIAL RESULTS ..................... 55 
20. RESPONSIBILITIES THAT EACH PARTY SHOULD BEAR ........................ 55 
20.1. Responsibilities of the Sponsor ............................................................. 55 
20.2. Responsibilities of Clinical Trial Institution and Investigator ................ 56 
20.3. Responsibilities of other interested parties ........................................... 57 
Statement of Investigator..................................................................................... 58 
Appendix 1: STUDY DEVICES CODE LIST ........................................................ 59 
Appendix 2: REFERENCES ................................................................................. 60 
 
 

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While repeat ablations for a recurrence may be conducted at any 
point during the study duration, repeat ablations to correct an 
ablative margin may only be performed within the first 30 days of the 
original ablation (by Visit 3).   

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coagulation dysfunction (bleeding tendency, prothrombin 
time [PT] was greater than normal control for 3~5 seconds, 
platelet count [PLT] was less than 50x109/L, and the 
international normalized ratio [INR] was greater than 1.5). 
8. Patient with renal failure and on renal dialysis. 
9. Scheduled concurrent procedure other than MW ablation in 
the liver. 
10. Pregnant or breast feeding. 
11. Physical or psychological condition which would impair study 
participation. 
12. Participation in any other interventional clinical study within 1 
month before screening and concurrently during the study. 
13. The patient is judged unsuitable for study participation by the 
investigator for any other reason. 
Study Duration 
Planned 
recruitment period: approximately 
8 
months for 
137 patients at 4 participating sites. 
 
Follow-up period: 36 months. 
Safety 
Patients will be assessed for all AEs and SAEs for 30 days after any 
ablation procedure (original or additional); after 30 days post an 
ablation procedure through the end of the study, only SAEs will be 
reported. 
Statistical 
Methods 
Categorical variables will 
be summarized descriptively by 
frequencies and associated percentages. Continuous variables will 
be summarized descriptively by number of patients, mean, standard 
deviation, median, minimum, and maximum. Confidence intervals 
will also be provided for procedure-related variables. 
 
The number and percentage of tumors achieving Technical Success 
will be summarized and a 95% confidence interval will be estimated.
Technical Success will be evaluated based on the margin achieved 
after the first ablation and prior to any repeat ablations within the first 
7 days.  
 
A similar summary will be provided for Technical Efficacy. This 
endpoint will be based on the scan obtained at Visit 3 and will count 
as successes patients with A0 or A1 margins in that scan and who 

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did not have an A2 margin since the Visit 2B scan. Additionally, if a 
patient received a repeat ablation for correcting a margin (to go from 
A1 to A0) within the first 30 days, this will also count as a success. 
Patients with repeat ablations to correct an A2 margin from Visit 2B 
to Visit 3 will not count as success for Technical Efficacy. The 
number and percentage of tumors with A0 and A1 margins will be 
presented as a sub-categorization within each presentation of 
Technical Success and Technical Efficacy, as well as a 
summarization for the number and reasons for repeat ablations 
through Visit 3. 
 
Local tumor progression rates at 1, 3, 6, 9, 12, 18, 24, 30 and 36 
months will be estimated using the Kaplan-Meier method and 95% 
confidence intervals will be provided. Any repeat ablation required 
after Visit 3 (Month 1) will be identified as an instance of local tumor 
progression. A similar summary will be provided for the 36-month 
overall and progression-free survival rates. 
 
The number and percentage of patients experiencing AEs will be 
summarized at the preferred term level using the Society of 
Interventional Radiology (SIR) clinical practice guidelines for event 
categorization. A similar summary will be provided for device-related 
AEs, procedure-related AEs, all SAEs, device-related SAEs, and 
procedure-related SAEs. 
 
Three analyses of study data are planned. The first will occur after 
all enrolled patients have completed the 1-month visit and is 
intended to provide an initial estimate of device effectiveness for 
Technical Success as well as to summarize the peri-operative until
1-month post-ablation safety profile of patients undergoing MW 
ablation. A similar analysis will occur after all patients have 
completed the 12-month visit and will include a summary of local 
tumor progression rates as well as safety through one year. There 
are no plans to use the results of either analysis for the purpose of 
stopping the study early. The third analysis will occur after all 
patients have completed study participation. 

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Table 1: Schedule of Activities 
 
Visits 
Screening  Ablation 
Post 
ablation 
1 month 
post ab. 
3 months 
post ab. 
6 months 
post ab. 
9 months 
post ab. 
1 year 
post ab. 
18 months 
post ab. 
2 years 
post ab. 
30 months 
post ab. 
3 years 
post ab. 
USV
12 
 
Visit 1  
Visit 2A 
Visit 2B 
Visit 3 
Visit 4 
Visit 5  
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Visit 10 
Visit 11 
 
Interval Windows: 
Activities 
within 14 d 
prior to
ablation 
Day 0 
within 7 d 
after
ablation  
1 month 
(+/- 7 d)
3 months 
(+/- 7 d)
6 months 
(+/-14 d)
9 months 
(+/-14 d)
12 months 
(+/-14 d)
18 months 
(+/-28 d)
24 months 
(+/-28 d)
30 months 
(+/-28 d)
36 months 
(+/-28 d)
N/A 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Demographic information 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Medical/surg/rad history
1 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Inclusion / exclusion 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
Pain score (NPRS) 
X 
 
X 
X 
 
 
 
 
 
 
 
 
 
EORTC QLQ-C30/HCC18
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
MRI scan (liver) 
X
2 
 
X
3 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
CT scan of the liver 
O
2 
X
4 
 
 
 
 
 
 
 
 
 
 
 
Ultrasound (liver) 
O
2 
X
4 
 
 
 
 
 
 
 
 
 
 
 
Pregnancy test
5 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Laboratory tests
6 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
ECOG performance 
status 
X 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Child-Pugh Score 
X 
 
 
 
 
 
 
 
 
 
 
 
 
ASA score 
X 
 
 
 
 
 
 
 
 
 
 
 
 
Procedure details
7 
 
X 
 
 
 
 
 
 
 
 
 
 
 
Device accountability 
 
X 
 
 
 
 
 
 
 
 
 
 
 

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Visits 
Screening  Ablation 
Post 
ablation 
1 month 
post ab. 
3 months 
post ab. 
6 months 
post ab. 
9 months 
post ab. 
1 year 
post ab. 
18 months 
post ab. 
2 years 
post ab. 
30 months 
post ab. 
3 years 
post ab. 
USV
12 
 
Visit 1  
Visit 2A 
Visit 2B 
Visit 3 
Visit 4 
Visit 5  
Visit 6 
Visit 7 
Visit 8 
Visit 9 
Visit 10 
Visit 11 
 
Interval Windows: 
Activities 
within 14 d 
prior to 
ablation 
Day 0 
within 7 d 
after 
ablation  
1 month 
(+/- 7 d) 
3 months 
(+/- 7 d) 
6 months 
(+/-14 d) 
9 months 
(+/-14 d) 
12 months 
(+/-14 d) 
18 months 
(+/-28 d) 
24 months 
(+/-28 d) 
30 months 
(+/-28 d) 
36 months 
(+/-28 d) 
N/A 
Length of hospital stay 
 
 
X 
 
 
 
 
 
 
 
 
 
 
Complete tumor ablation 
evaluation 
 
 
X 
X 
 
 
 
 
 
 
 
 
 
LTP evaluation
8 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Progression-free survival
8 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Concomitant meds
9 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Concomitant procedures
10
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
AEs and SAEs
11 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Symbol: O  means that ultrasound and computed tomography (CT) scans are optional for Screening. 
Abbreviations: ab. = ablation; AEs = adverse events; ASA = American Society of Anesthesiologists; CT = computed tomography; d = days; ECOG = Eastern 
Cooperative Oncology Group; EORTC QLQ = European Organization for Research and Treatment of Cancer Quality of Life Questionnaire; HCC = hepatocellular 
carcinoma; LTP = local tumor progression; meds = medications; MRI = Magnetic Resonance Imaging; NPRS = numeric pain rating scale; rad = radiation; 
SAEs = serious adverse events; SOC = standard of care; surg = surgical; USV = unscheduled visit. 
Notes:
1. 
Review and collect medical, surgical, and radiation histories, including alcohol consumption and hepatitis, if applicable. Note: HCC diagnosis does not need 
to be reported as medical history. 
2. 
At minimum, an MRI of the liver must be taken at Baseline/Screening (per each 
 to ascertain tumor type, location, and size (measured in 
longest diameter and the diameter that is perpendicular to this longest diameter). Tumor size must be measured with at least 2D imaging. The MRI must 

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be taken within 14 days prior to ablation (Visit 2A). Ultrasound and/or CT are optional. 
3. 
An MRI must be taken within 7 days following the ablation procedure. 
4. 
Ultrasound and/or CT will be used to guide the probe into place and confirm accurate placement of the probe prior to ablation . For ultrasound, a video of 
the ablation may be submitted to the Sponsor. 
5. 
Serum pregnancy test, for women of childbearing potential only, must be performed within 14 days prior to ablation (Visit 2A); otherwise the test must be 
repeated and available prior to ablation. 
6. 
All laboratory tests must be performed within 14 days prior to ablation (Visit 2A), otherwise the test(s) must be repeated and available prior to ablation. For 
follow-up Visits 3 to 11, the laboratory tests may be done within 7 days prior to the respective visit. The laboratory tests are: coagulation (PT, APTT, INR); 
liver function (AST, ALT, GGT, albumin, indirect, direct and total bilirubin, and total protein); renal function  (Urea, creatinine and electrolytes (sodium, 
potassium and chloride); complete blood count (differential cell count and platelet count); and, alpha-fetoprotein. 
7. 
Procedure details include, but are not limited to, the following: complete procedure time; ablation time; anatomical location of ablation; number of probe 
placement attempts; number of ablations, ablation maximum power and time used for each probe and ablation; guidance method used; number of ultrasound 
scans performed for probe and margin assessment.  While repeat ablations for a recurrence may be conducted at any point during the study duration, 
repeat ablations to correct an ablative margin may only be performed within the first 30 days of the original ablation (by Visit 3).  Procedure details should 
be collected for all re-ablations, if applicable. 
8. 
Local tumor progression (LTP) and Progression-free survival will be evaluated by a study physician based on MRI imaging.  Progression-free survival may 
be reported by 
ferent than the study physician. All MRI scans are to be submitted to the Sponsor. If there is a progression, 
the study physician should specify if the progression is of the original target tumor, a new HCC tumor in the liver or a distant metastasis. 
9.
Include all relevant medications taken within 14 days prior to prior to ablation (Visit 2A) and taken throughout the study.  Relevant medications include 
chemotherapy, blood-thinning or coagulation, NSAIDs, those medications used to treat AEs, and those used for hepatitis (if concurrently treating).  Note:  
Elements that comprise anesthesia do not require reporting into the clinical database. 
10. Record only relevant concomitant procedures. 
11. Patients will be assessed for all AEs and SAEs for 30 days after any ablation procedure (original or additional); after 30 days post an ablation procedure 
through the end of the study, only SAEs will be reported. 
12. Record reason for unscheduled visit, as well as all AEs and SAEs if within 30 days after an ablation procedure, and only SAEs if after 30 days post an 
ablation procedure, and any updates to the relevant concomitant medications and relevant concomitant procedures. 
. 

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1. SPONSOR INFORMATION 
(1) Name of Sponsor: 
NeuWave Medical, Inc. 
3529 Anderson Street 
Madison, Wisconsin, 53704, USA 
 
(2) Contact of Sponsor:
 
 
 
 
 
 
(3) Related qualification documents of Sponsor: 
The CE certification is available as a separate attachment. 
 
(4) Name, address, contact and related qualification documents of agent: 
 
 
 
 
 
 
The business license is available as a separate attachment. 
 
 

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2. LIST OF CLINICAL TRIAL INSTITUTIONS AND INVESTIGATORS  
Code of 
clinical trial 
institution 
Name of clinical trial institution 
Investigator  
Title 
01069* 
Chinese PLA General Hospital 
Ping Liang 
Director 
01065# 
Sun Yat-sen University Cancer Center 
Jinhua Huang 
Director 
01066# 
The First Affiliated Hospital
Sun Yat-sen 
University 
Xiaoyan Xie 
Director 
01067# 
Renji Hospital, Shanghai Jiao Tong 
University School of Medicine 
Bo Zhai 
Director
* Information of leading site and principal investigator 
# Information of co-site and co-principal investigator.  

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3. OBJECTIVE AND CONTENTS OF CLINICAL TRIAL
3.1. Objective of Clinical Trial
The key objective of this study is to evaluate the efficacy and safety of the NeuWave Certus 
Microwave Ablation System in the treatment of Chinese patients with a single hepatocellular 
carcinoma (HCC) tumor up to 5 cm or a maximum of 3 HCC tumors up to 3 cm per tumor. 
3.2. Contents of Clinical Trial 
This single-arm, prospective, multicenter study will enroll approximately 137 Chinese patients 
who have a single HCC tumor up to 5 cm or a maximum of 3 HCC tumors up to 3 cm per tumor. 
All qualified patients at the 4 participating study sites will receive the same procedure: 
microwave ablation using only the NeuWave Certus Microwave Ablation System. Patients in 
this study will come to their study site for the ablation procedure. 
If the Study Doctor decides it is warranted for patient safety, the patient will 
remain in the hospital longer. All patients will be required to return to their study site for 9 
follow-up visits over a period of 36 months to assess efficacy and safety.  
Efficacy will be assessed by using contrast-enhanced Magnetic Resonance Imaging (MRI) to 
verify that the patient
around the ablated tumor. When the MRI scans are done within 7 days after the ablation, 
Technical Success is assessed. When the MRI scans are done 30 days (± 7 days) after 
ablation, Technical Efficacy is assessed. At every follow-up visit, the patient will be scanned 
with at least one MRI to see if there are any tumor foci at the edge of the ablation zone, which 
indicates local tumor progression (LTP). These MRIs will also serve as the basis for 
determining progression-free survival, defined as length of time from the original ablation 
procedure until any type of disease progression (i.e. local or distant). Another valuable 
endpoint during the 36-month follow-up period will be overall survival, measured from the time 
of the original ablation procedure to the time of death or last follow-up if death has not occurred.  
Patients will be assessed for all AEs and SAEs for 30 days after any ablation procedure 
(original or additional); after 30 days post an ablation procedure through the end of the study, 
only SAEs will be reported and assessed.   
 
4. BACKGROUND INFORMATION OF CLINICAL TRIAL 
4.1. Introduction to the Condition 
4.1.1. Explanation for the Condition 
Primary liver cancer or HCC is the most common type of liver cancer in Asia where chronic 
hepatitis B virus and hepatitis C virus infections are the major causes of liver cancer. Other 
causes include toxic injury, typically initiated by ingestion of aflatoxin or consumption of alcohol. 
Incidence rates of HCC in men are more than twice those in women as men have higher rates 

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of chronic hepatitis B virus (HBV) and hepatitis C virus (HCV) infection, and chronic alcohol 
consumption with possible hormonal influences on modulation of hepatocarcinogenesis. 
HCC is the sixth most common cancer worldwide with approximately 782,000 new cases and 
745,000 deaths annually.1 and the third most common cause of death from cancer (598,000 
deaths annually).2 More recently in China, liver cancer is the second major cause of cancer 
deaths, with a mortality rate of 26.26 per 100,000 (males: 37.55 and females: 14.45 per 
100,000), accounting for 19.33% of all sites of cancers. Accordingly, the estimated annual 
incident cases and deaths of liver cancer are 360,000 and 350,000, respectively.3 
Surgical resection is the reference standard for treatment of HCC, however only a small 
proportion of HCC patients are candidates because of disease progression, anatomical 
location, and/or poor liver function. In these cases, imaging-guided percutaneous ablation can 
easy to operate, easy to implement repeatedly, and has relatively low cost.4 Recurrence of 
HCC is common in patients who have undergone surgical resection; for those patients, the 
image-guided methods are easier and safer option than surgical resection. Indeed, image 
guided methods have been widely used in China.
Due to the heterogeneous epidemiology and clinical presentation of HCC worldwide, there are 
no universally accepted consensus practice guidelines for HCC. In Asia, there are regional 
and national guidelines based on the experience of the consensus group members and the 
practice relevant to the epidemiology. In 2011, Chinese experts published their consensus on 
ablation for HCC.3 In this consensus, local ablation therapy is considered as one of the radical 
treatments of small HCC. 
Microwave Ablation to Treat HCC in China 
The largest clinical experience using MW ablation to treat HCC comes from China, in part due 
to early adoption of MW ablation systems available only in Asia. That multicenter study of 1007 
patients with primary liver cancer showed a technical success of 97.1% (1276/1363) and a 
local tumor progression rate of 5.9% (78/1363) with a mean follow-up time of 17.3 months 
(range, 3-68.9 months). The 1-, 3- and 5-year overall survival rates were 91.2%, 72.5% and 
59.8%, respectively.5 
A retrospective study of MW ablation as a first-line treatment for HCC evaluated the long-term 
outcomes and prognostic factors of 221 consecutive patients receiving MW ablation in Renji 
Hospital (Shanghai) between October 11, 2010 and December 31, 2013 were enrolled. 
Technique effectiveness was evaluated 1-month post-ablation. Initial complete ablation was 
found in 201 (90.95%) patients, secondary technique effectiveness in 8 (3.62%) patients, and 
the remaining 12 (5.43%) patients suffered from incomplete ablation after 2 sessions of MW 
ablation. No patients died within 30 days post ablation. Major complications occurred in 8 
(3.8%) patients. It was concluded that MW ablation provides high technique effectiveness rate 
and is well tolerated in patients with HCC as a first-line treatment.6 
 

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Literature Review 
Pre-clinical and clinical data has shown that MW ablation is safe and effective in liver tumors 
with low complication rates, high rates of technical success, lower rates of local tumor 
progression and promising disease-free and overall survival rates than have historically been 
reported for radiofrequency (RF).7 
Based on a review of the current literature on clinical MW ablation, collectively 3, the studies 
demonstrate that microwave (MW) ablation is a safe and effective therapy for tumors in the 
liver, lung, kidney and bone when compared with the current clinical standard, RF ablation. In 
particular, they demonstrate that MW ablation is associated with high rates of technical 
success, low
 complication rates, low rates of local recurrence and good long-term 
survival. In addition, the studies illustrate several advantages of MW ablation, including uniform 
cell kill within ablation zones, multiple-antenna capability, and improved perivascular ablation. 
The treatments were performed using multiple different MWsystems characterized by different 
frequencies, maximum power, antenna size, antenna design, and feed line cooling mechanism. 
Despite differences in system design, the studies consistently established that MW ablation is 
safe and effective. While the majority of the studies focus on the use of microwaves for focal 
tumor ablation, several studies have demonstrated that microwaves are also an effective 
means of achieving precoagulation during liver resections.
4.1.2. Therapeutic Option and Prognosis 
Microwave Ablation Compared with Hepatic Resection 
Shibata et al 8  conducted a randomized trial of patients with multiple resectable liver 
metastases from colorectal cancer who underwent either intraoperative MW ablation (14 
patients) or hepatectomy (16 patients). There was no significant difference in survival rates 
between the two groups. The 1-, 2-, and 3-year survival rates and mean survival times were 
71%, 57%, 14%, and 27 months, respectively, in the MW group, and 69%, 56%, 23%, and 25 
months, respectively, in the hepatectomy group. However, operative blood loss and the need 
for transfusions were significantly lower in the MW ablation group. Recently, Zhang et al9 
compared the efficacy of liver resection with percutaneous MW ablation for patients with single 
small (<3 cm) HCCs. Patients (n=190) had Child Pugh A cirrhosis. Major complications were 
significantly higher in the resection group (22.1% vs 5.9%, p=0.004). There was no significant 
difference in overall survival, but the disease-free survival was significantly higher in patients 
who underwent resection, except for patients with portal hypertension (overall survival [OS] 
and disease-free survival [DFS] were similar between groups).  
Shi et al10 compared MW ablation and surgical resection for treating patients with HCC within 
Milan criteria. For solitary tumors  3 cm, DFS and OS were similar for patients treated with 
MW ablation and resection. For all patients within Milan criteria, there was no difference in OS, 
but resection was associated with a higher rate of DFS. Chong et al 11  conducted a 
retrospective study comparing MW ablation with liver resection and found that with propensity 
score matching of the two groups that resulted in 63 matched pairs, liver resection had better 
overall survival and disease-free survival in patients with albumin-bilirubin grade 1. However, 

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MW ablation showed a significantly better overall survival and a trend towards better disease-
free survival in patients with albumin-bilirubin grade 2 or 3. 
Adoption of MW ablation systems has previously been limited by technical problems 
associated with suboptimal power handling, large antenna diameter, antenna shaft heating 
and unpredictable heating patterns. Despite these limitations, the results of clinical MW 
ablation studies have historically compared favorably with those of RF ablation. In a recent 
meta-analysis, RF ablation and MW ablation had similar 1- to 5-year overall survival, disease-
free survival, local recurrence rate, and adverse events (AEs). However, MW ablation 
demonstrated a superior 6-year overall survival.12 As MW ablation technology has advanced, 
and our understanding of MW energy delivery has improved, MW ablation systems have 
become increasingly utilized in interventional oncology practices. 
4.2. Application of Investigational Product 
Thermal ablation is increasingly utilized in the treatment of primary and metastatic liver tumors, 
both as curative therapy and as a bridge to transplantation. Recent advances in high-powered 
MW ablation systems have allowed physicians to realize the theoretical heating advantages 
of MW energy compared with other ablation modalities. As a result, there is a growing body of 
literature detailing the effects of MW energy on tissue heating, as well as its effect on clinical 
outcomes.13 
Multiple-Antenna Microwave Ablation 
Several reports have demonstrated that multiple-antenna MW ablation is safe and improves 
treatment efficacy. Multiple antennas were used in the studies by Simon et al14 and Meredith 
et al15 described above. In addition, Yu et al16 treated nine patients with intraoperative MW 
prior to resection of HCC. The ablations were performed with a single straight antenna, three 
straight antennas, or three looped antennas. The coagulation volumes were significantly larger 
for the three-antenna configurations and the study showed that multiple antennas are a 
promising way to safely, rapidly and effectively treat large HCCs. Uniform cell kill within the 
ablation zone was also seen in this study. 
Microwave Ablation with a Gas-Cooled System
The results of HCC treatment with a high-power, gas-cooled, multiple antenna-capable MW 
device were retrospectively reviewed by Ziemlewicz et al.17 A total of 107 HCCs in 75 patients 
were treated via percutaneous approach. All procedures were performed with a single MW 
system (Certus) with one to three 17-gauge antennas. Primary technique effectiveness rate 
was 91.6% (98 of 107) overall. Ziemlewicz concluded that treating HCC with a gas-cooled, 
multiantenna-capable MW ablation device is safe, with promising treatment effectiveness. 
4.3. Product Registration and Reason for Clinical Trial Registration in China 
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 most common applications by clinicians have been the ablation of liver, 
kidney, and lung tumors. Additional, but less common uses have been nerve ablation and the 

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ablation of soft tissue tumors in bone. 
This device has not been used in general ablation procedures in the Chinese population. 
Therefore, the clinical study is designed to support the registration of the device in China. 
 
5. FEATURES, STRUCTURAL COMPOSITION, OPERATION PRINCIPLE, 
MECHANISM OF ACTION, AND STUDY POPULATION 
5.1. Features 
5.1.1. Design Features of Study Product 
Neuwave Medical  Certus Microwave Ablation System and Accessories consists of Software 
version 3.0.X and the accessories NEUWAVE Certus PR, NEUWAVE Certus LK, and 
NEUWAVE Certus SR ablation probes. Several accessories designed to allow for the 
mechanical interfacing of the Power Distribution Module (PDM) to a variety of  
(computed tomography) tables are also available. These accessories are ease-of-use and 
convenience accessories that do not impact the clinical functionality of the system and thus 
are not described in detail. 
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. 
The Certus Microwave Ablation System and Accessories are intended to ablate/coagulate soft 
tissue using microwaves in the United States. The Certus Microwave Ablation System and 
Accessories are general purpose thermal ablation tools used by physicians to ablate soft tissue 
tumors in a wide variety of tissue and disease states in the United States.  
The risk/benefit profile of the Certus Microwave Ablation System and Accessories is 
acceptable for the intended use of the ablation/coagulation of soft tissue relative to other 
medical alternatives. 
5.2. Study Population 
The study population will include 137 Chinese patients with a single HCC tumor up to 5 
cm or a maximum of 3 HCC tumors up to 3 cm per tumor. 
 
6. INDICATIONS AND CONTRAINDICATIONS, PRECAUTIONS 
6.1. Indications 
The Certus Microwave Ablation System and Accessories form a Microwave Ablation System, 
which is intended to ablate/coagulate soft tissue. The Certus Microwave Ablation System and 
Accessories are general purpose thermal ablation tools used by physicians to ablate soft tissue 

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tumors in a wide variety of tissue and disease states. The most common applications by 
clinicians have been the ablation of liver, kidney and lung tumors. Additional, but less common 
uses have been the ablation of soft tissue tumors in bone and nerve ablation. 
6.2. Contraindications 
 
 
Use in cardiac procedures. 
 
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. 
 
Use on the central nervous system. 
 
Endometrial applications. 
 
6.3. 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.  
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. 
 

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7. OVERALL DESIGN 
7.1. Trial Design 
This is a single-arm, prospective, multicenter study. Individuals who are assessed for MW 
-of-care (SOC), who meet study 
entry criteria and sign the informed consent will be enrolled. The patients will be treated with 
MW ablation and afterwards will be followed for up to 36 months after the ablation procedure 
to assess safety and ablation outcomes. In addition to the final analysis after all enrolled 
patients complete the 36-month observation period, a summary of selected endpoints will be 
provided after all enrolled patients have completed each of the 1-month and 12-month visits. 
7.1.1. Trial Objective 
The key objective of this study is to evaluate the efficacy and safety of the NeuWave 
Certus Microwave Ablation System in the treatment of Chinese patients with a single HCC 
tumor of up to 5 cm 
. 
7.1.2. Trial Endpoints 
Efficacy Endpoints 
The efficacy endpoints are defined, as follows:
 
Technical Success, defined as a combination of A0 ablations (complete tumor ablation 
with a surrounding 5 mm margin) and A1 ablations (complete tumor ablation with 
inadequate margins) based on contrast-enhanced MRI performed up to 7 days 
following the original ablation procedure.  
 
Technical Efficacy, defined as a combination of A0 ablations (complete tumor ablation 
with a surrounding 5 mm margin) and A1 ablations (complete tumor ablation with 
inadequate margins), based on contrast-enhanced MRI scans at 1 month (+/- 7 days) 
after the original ablation procedure. 
 
Local tumor progression (LTP), evaluated at every visit after the ablation of the target 
tumor(s). LTP describes the appearance of tumor foci at the edge of the ablation zone, 
after at least one contrast-enhanced follow-up MRI scan has documented adequate 
ablation and an absence of viable tissue in the target tumor and surrounding ablation 
margin by using imaging criteria. 
 
Secondary efficacy rate, defined as the percentage of tumors that have undergone 
successful repeat ablation following identification of local tumor progression at any 
time during study follow up. 
 
Progression-free survival, defined as length of time from the original ablation 
procedure until any type of disease progression (i.e. local or distant). 
 
Overall survival measured from the time of the original ablation procedure to the time 
of death or last follow-up if death has not occurred. 
 
 

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Safety Endpoint 
 
 
 
 
 
 
 
 
 
 
 
7.1.3. Trial Method Selection and Its Rationale 
This is a single-arm, prospective study. As such, there is no randomization or control groups. 
standard of care (SOC), who meet study entry criteria and sign the informed consent will be 
enrolled. Because it is a prospective study, selection bias may be reduced.  
7.1.4. Measures to Reduce and Avoid Bias 
There will be no central reviewer, however, all MRI scans and the ultrasound video taken on 
the day of ablation should be sent to the Sponsor. 
The study related data will be recorded in the original Medical Records and reviewed during 
the monitoring process. Proper Training for the investigators will be planned to ensure all 
investigators have equal adequate experience with the device prior to commencing enrollment 
at their site. In addition, all sites will treat a minimum of 3 patients each, as part of the roll-in 
phase, which will only be included in the safety set. This is intended to reduce any operational 
bias due to learning curve.  
The investigator should communicate further with the patients to improve the patient 
compliance. This will help to reduce the informational bias. 
 

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7.1.5. Selection of Patients 
1) 
Inclusion criteria 
 
 
 
 
 
 
 
 
 
 
 
 
 
2) 
Exclusion criteria 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
3) 
 
The Sponsor has the right to terminate the study early for a single site, multiple sites or all sites 
temporarily or permanently. Reasons may include, but are not limited to: safety issue or ethical 
issue, inaccurate or incomplete data record, non-compliance or dissatisfactory quality or 
quantity of the recruited patients. Health authorities also have the right to terminate a study.  

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This study does not require a Data Safety Monitoring Board. 
Other criteria:  
Patients may be withdrawn if any of the following complications or adverse situations occur: 
 
The patient experiences a major complication, which is defined as an event that leads 
to substantial morbidity and disability (e.g., results in the unexpected loss of an organ) 
that increases the level of care, or results in hospital admission, or substantially 
lengthens the hospital stay (Society of Interventional Radiology [SIR] classifications C 
to E).  
 
The patient requires a blood transfusion or interventional drainage procedure.  
 
If this study is terminated or discontinued early, the Sponsor or its representative will inform 
the investigator/affiliated unit and regulatory authority of the termination of the study and the 
reasons for the termination or discontinuation, according to the applicable requirements. The 
Sponsor or investigator/affiliated unit should also inform ECs and include the reasons for 
termination or discontinuation, according to the applicable requirements. In addition, all unused 
procedures. 
Study/treatment termination and patient discontinuation criteria and procedures  
In accordance with the current revision of the Declaration of Helsinki, a patient has the right to 
withdraw from the study at any time for any reason without prejudice to their future medical 
care by the physician or the institution. Should a patient (or patient
guardian/representative) decide to withdraw, 1) all data collected up to the point of withdrawal 
will be considered for analysis; and 2) all efforts will be made to collect and report the final visit 
observations as thoroughly and timely as possible. The primary reason for early withdrawal 
will be recorded on the electronic case report form (eCRF). The criteria for 
:
Withdrawal of consent: Any method of contact with the patient in which the patient  states 
that he or she no longer wants to participate in the study-specific activities constitutes 
withdrawal of consent from 
-
and should be documented in the eCRF; or, the investigator may determine the withdrawal of 
patients from the study according to reasonable medical judgement;  
Adverse event: The AE or SAE may not cause the patients to discontinue the study. If the 
investigator decides to withdraw a patient from the study, this patient must be followed up, until 
the AE is resolved or until the stable clinical endpoint is reached; 
Death: The cause of death will be documented. 
Lost-to-follow-up: All patients should be able to participate in all scheduled clinical follow-ups, 
providing the appropriate contact information. If a patient 
scheduled 

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clinical visit, attempts to contact the patient by phone should be done for 3 times to ask the 
patient to participate in all scheduled clinical follow-ups. Each attempt to contact should be 
recorded in the source document. If the patient makes no response to all three times of 
telephone contact, the investigator must send a registered mail to the patient. If the patient 
makes no response to the registered mail and makes no further contact, the patient is 
considered lost-to-follow-up and the respective eCRF will be completed. 
Procedure for Patient
Discontinuation from the Study: 
The patients must return for all follow-up visits as specified at the end of the synopsis in Table 1: 
Schedule of Activities. If the patient is withdrawn from the study early, the reasons for 
termination will be documented in the source document and site files and submitted via the 
eCRF. 
Patients withdrawn from the study early will be included in the analysis of results, however, no 
new patients will be recruited to replace the patients withdrawn from the study as a 20% 
attrition rate has already been considered in the current sample size. 
4) Enrollment 
Patients will be considered enrolled into the study upon satisfaction of the following criteria:  
 
Completion of the informed consent process. 
 
It is determined by the investigator that the patient meets all inclusion criteria and 
does not meet any exclusion criteria.
No procedures related to the study and which are not SOC should be conducted prior to 
signing the informed consent. 
5) Expected overall duration of clinical trial and reasons for determination
The expected overall duration is approximately 65 months, including the time that each site  
Ethics Committee takes to approve the trial protocol, institution contract sign-off, Human 
Genetic Material Office approval, duration of patient enrollment, duration of follow-up, time for 
data management, statistical analysis, and time to write, review and approve the clinical study 
report. 
6) Expected duration of participation of each patient 
The duration of each patient s participation in the study will be around 37 months (about 
1 month for Screening and 36 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 patients required for clinical trial 
This study will include 137 patients, of which 3 patients per site (n=12) will be part of the run-
in phase. This is a single-arm study, and hence there will be no randomization of patients. See 
Section 8.2 
Sample S
this sample size. 

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7.1.6. Efficacy Evaluation Method 
1) Description of efficacy parameters 
The efficacy endpoints and their definitions are the following: 
Technical Success, defined as a combination of A0 ablations (complete tumor ablation 
with a surrounding 5 mm margin) and A1 ablations (complete tumor ablation with 
inadequate margins) based on contrast-enhanced MRI, performed up to 7 days 
following the original ablation procedure.  
 
Technical Efficacy, defined as a combination of A0 ablations (complete tumor ablation 
with a surrounding 5 mm margin) and A1 ablations (complete tumor ablation with 
inadequate margins), based on contrast-enhanced MRI scans at 1 month (+/- 7 days) 
after the original ablation procedure. 
 
Local tumor progression (LTP), evaluated at every visit after the ablation of the target 
tumor(s). LTP describes the appearance of tumor foci at the edge of the ablation zone, 
after at least one contrast-enhanced follow-up MRI scan has documented adequate 
ablation and an absence of viable tissue in the target tumor and surrounding ablation 
margin by using imaging criteria. 
 
Secondary efficacy rate, defined as the percentage of tumors that have undergone 
successful repeat ablation following identification of local tumor progression at any 
time during study follow up. 
 
Progression free survival, defined as length of time from the original ablation 
procedure until any type of disease progression (i.e. local or distant). 
 
Overall survival measured from the time of the original ablation procedure to the time 
of death or last follow-up if death has not occurred. 
2) Selection of method and time to evaluate, record, and analyze the efficacy 
parameters 
The primary effective parameters in this study will be assessed by the investigator(s) at each 
site based on examining image data.  
7.1.7. Safety Evaluation Method 
1) Description of safety parameters 
The safety parameters in this study are all AEs and SAEs for 30 days after any ablation 
procedure (original or additional); after 30 days post an ablation procedure through the end of 
the study, only SAEs will be reported and assessed. The safety endpoint is the rate of AEs 
and SAEs reported at each analysis and cumulatively throughout the entire study period.  
2) Selection of method and time to evaluate, record, and analyze the safety parameters 

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Patients will be assessed for all AEs and SAEs for 30 days after any ablation procedure 
(original or additional); after 30 days post an ablation procedure through the end of the study, 
only SAEs will be reported. The safety parameters are recorded on the e-CRF according to 
 record, medical record, and all other related source documents, which are 
collected at each follow-up visit.  
7.2. Study Process 
7.2.1.
Study Flowchart
 
 
7.2.2.
Procedure Description
who have a single HCC tumor up to 5 cm or a maximum of 3 HCC tumors 
of up to 3 cm per tumor will receive the same procedure: microwave ablation using only the 
NeuWave Certus Microwave Ablation System. Patients in this study will come to their study 
site for the ablation procedure. 
and afterwards may return home; 
 
A minimum of one MRI of the liver must be taken at Baseline/Screening to ascertain tumor 
type, location, and size. (Tumor size will be measured in longest diameter and the diameter 
that is perpendicular to this longest diameter; tumor size must be measured with at least 2D 
imaging.) Physicians who are experienced with tumor ablation will do all ablations 
percutaneously using only the NeuWave Certus Ablation System. During the ablation, patients 
will be under an anesthesia method as per the 
SOC. Ultrasound and/or CT scan 
will be used to guide the probe to the tumor and confirm accurate placement of the probe prior 
to emitting the microwaves.  
Within 7 days after ablation, contrast-enhanced MRI will be done to confirm the completion of 
the ablation procedure. According to the standard practice at each study site, ablation 
confirmation will be classified as: 
 
Complete tumor ablation with adequate margin (A0). 
 
Complete tumor ablation with insufficient margin (A1). 
 
Incomplete tumor ablation (A2). 

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At every follow-up visit, the patient will be scanned with at least one MRI to 
see if there are any tumor foci at the edge of the ablation zone, which indicates local tumor 
progression (LTP). These MRIs will also serve as the basis for determining progression-free 
survival, defined as length of time from the original ablation procedure until any type of disease 
progression (i.e. local or distant). 
Microwave ablation (using the Certus Microwave Ablation System only) may be performed 
for recurrence of target tumor(s) or to achieve complete tumor ablation with adequate 
margin (A0) of the target tumor(s) if the initial ablation had an insufficient margin, if the 
treating physician deems appropriate and necessary.   While repeat ablations for a 
recurrence may be conducted at any point during the study duration, repeat ablations to 
correct an ablative margin may only be performed within the first 30 days of the original 
ablation (by Visit 3). 
 
7.2.3. Standard Operating Procedures of Medical Device 
According to Instructions For Use (IFU) and technical manual of the product, the requirements 
for the use of study product are as follows: 
a. Indications and scope of application: 
The NeuWave Certus Microwave Ablation System is indicated for the ablation (coagulation) 
of soft tissue. The NeuWave Certus Microwave Ablation System is not indicated for use in 
cardiac procedures. The system is designed for facility use and should only be used under the 
orders of a physician 
b. Recommended operating mode for the Certus system: 

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Microwave ablation is a minimally 
invasive procedure that uses electromagnetic waves to generate tissue necrosis in the 
liver in this study. Using contrast-enhanced ultrasound imaging or CT scan guidance, a 
small probe is inserted percutaneously into the tumor. 
The ablation will be performed with a single high-powered, gas-cooled, multiple antenna
capable MW 
Certus Ablation System and Accessories) with 
single or multi-
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. Antenna placement may be performed under real-time contrast- enhanced 
ultrasound imaging guidance. Single or multiple ablation sessions may be done in one 
procedure. It is suggested that the physician considers using more than one probe for 
tumors  2 cm. 
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 tissue 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 is done either percutaneously, 
via laparoscope, or in open surgical settings. 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. The design 
differences in certain Certus Ablation Probes are intended to optimize the efficiency of 
energy transferred from the probe into different tissue types. Model Certus LK probes are 
designed to optimize energy transfer efficiency in liver tissue based on tissue properties.  
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-
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, the 
functional controls become active.  
Pressing the Ablation Tissu-
2 cooling system to cool the Tissu-
-15°C. Once the Tissu-
reaches -5° C, the button turns gray, a green check mark appears on the button, and the 
-
 

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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 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. 
c. 
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. 
 
 

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7.2.4. Study Procedures 
 
 
 
Completion of the informed consent process and signing the Informed Consent Form 
(ICF). 
 
Verification of the eligibility criteria (Section 7.1) 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. 
 
Screening Failures 
Screened patients who are not enrolled will be considered screen failures. For patients who 
are determined to be screen failures, only the following data will be recorded on the eCRF: 
 
Informed consent date. 
 
Demographic information (age, race, gender, and ethnicity). 
 
Reason for screening failure. 
Randomization 
This is a single-arm study. Hence, there will be no control or comparison group, and therefore 
no need for randomization. 
Visit 1  Baseline/Screening Visit 
The following screening activities will occur 
 original ablation 
procedure:  
 
The patient must be given ample time to review and sign the ICF. 
 
Collect demographic information (year and month of birth, sex, race, ethnicity). 
 
Review and collect medical, surgical, and radiation histories, including alcohol 
consumption and hepatitis, if applicable. Note: HCC diagnosis does not need to be 
reported as medical history. 
 
Review inclusion/exclusion criteria and determine if the patient is eligible for 
participation. 
 
Pain, using the Numeric Pain Rating Scale (NPRS). 
 
Quality of Life questionnaires: EORTC QLQ-C30 and liver-specific EORTC QLQ-

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HCC18. 
 
At minimum, an MRI of the liver must be taken at Baseline/Screening (per each study 
diameter 
and the diameter that is perpendicular to this longest diameter). The MRI must be taken 
within 14 days prior to ablation (Visit 2A). Ultrasound and/or CT are optional. 
 
Laboratory tests must be performed within 14 days prior to ablation (Visit 2A); 
otherwise the test(s) must be repeated. 
o
Coagulation tests (PT, APTT, and INR). 
o
Liver function tests (AST, ALT, GGT, albumin, indirect, direct and total bilirubin, 
and total protein). 
o
Renal function tests (Urea, creatinine, and electrolytes [sodium, potassium, 
and chloride]). 
o
Complete blood count (differential cell count and platelet count). 
o
Alpha-fetoprotein test. 
o
Serum pregnancy test, for women of childbearing potential only. 
 
 
ECOG performance status.
 
Child-Pugh score. 
 
ASA score.  
 
Include all relevant medications taken within 14 days prior to the ablation (Visit 2A).  
Relevant medications include chemotherapy, blood-thinning or coagulation, NSAIDs, 
those medications used to treat AEs, and those used for hepatitis (if concurrently 
treating).   
Visit 2  Ablation Through Discharge 
 
 
 
Visit 2A
Day of Ablation 
Confirm inclusion and exclusion criteria prior to performing the activities below and collecting 
the respective data: 
 
Ultrasound and/or CT scan to guide the probe to the tumor and confirm accurate 
placement of the probe prior to emitting the microwaves. For ultrasound, a video of the 
ablation may be submitted to the Sponsor. The ultrasound videos will be used to review 
microbubble formation to see if there is a correlation with ablation area.  

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Procedure details: 
o
Complete procedure time. 
o
Ablation time. 
o
Anatomical location of ablation. 
o
Number of probe placement attempts.
o
Number of ablations. 
o
Ablation maximum power and time used for each probe and ablation. 
o
Guidance method used. 
o
Number of ultrasound and/or CT scans performed for probe and margin 
assessment. 
 
Device accountability: type(s) and number of probes used.
 
Any update to relevant concomitant medications. Exclude the elements of the 
medications that compose the anesthesia. 
 
All AEs and SAEs. 
Visit 2B
Post ablation 
The following data must be collected post ablation (up to 7 days after an ablation procedure): 
 
Pain, using the NPRS. 
 
Quality of Life questionnaires: EORTC QLQ-C30 and liver-specific EORTC QLQ-
HCC18. 
 
MRI scans of the liver (within 7 days after completion of ablation procedure to confirm 
complete tumor ablation). The MRI scans will be reviewed for reconciliation with the 
data provided by the treating physician regarding the ablation. 
 
Laboratory tests. 
o
Coagulation tests (PT, APTT, and INR); 
o
Liver function tests (AST, ALT, GGT, albumin, indirect, direct and total bilirubin, 
and total protein). 
o
Renal function tests (Urea, creatinine, and electrolytes [sodium, potassium, 
and chloride]). 
o
Complete blood count (differential cell count and platelet count). 
o
Alpha-fetoprotein (AFP) test. 
 
ECOG performance evaluation. 

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Length of hospital stay. 
 
Complete tumor ablation evaluation. 
 
Any update to relevant concomitant medications. 
 
Relevant concomitant procedures. 
 
All AEs and SAEs. 
Post Ablation Follow-up Visits 3 to 11 (End of Study)  
The following data will be collected post ablation at the post ablation follow-up visits, from 
Visit 3 through the end of the study (Visit 11), as follows: 
 
Pain score, using the NPRS (Visit 3 only). 
 
Quality of Life questionnaires: NPRS pain score
EORTC QLQ-C30 and liver-specific 
EORTC QLQ-HCC18.  
 
MRI of the liver. 
 
Laboratory tests. 
o
Coagulation tests (PT, APTT, and INR). 
o
Liver function tests (AST, ALT, GGT, albumin, indirect, direct and total bilirubin, 
and total protein). 
o
Renal function test (Urea, creatinine, and electrolytes [sodium, potassium, and 
chloride]). 
o
Complete blood count (differential cell count and platelet count). 
o
Alpha-fetoprotein (AFP) test. 
 
ECOG performance status.
 
Complete tumor ablation evaluation (Visit 3 only) 
 
Local tumor progression (LTP) to be evaluated by a study physician based on MRI 
imaging. All MRI scans are to be submitted to the Sponsor. 
 
Progression-free survival to be evaluated by a study physician based on MRI imaging 
or 
physician.  If there is a progression, the study physician should specify if the 
progression is of the original target tumor, a new HCC tumor in the liver, or a distant 
metastasis. 
 
Any update to relevant concomitant medications. 
 
Relevant concomitant procedures. 
 
All AEs (if within 30 days post an ablation procedure).  
 
All SAEs through end of study. 
 

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Note: Repeat ablations may be performed on target tumor(s) only. 
Unscheduled Visits 
The following data will be collected at all unscheduled visits: 
 
Reason for the unscheduled visit. 
 
Relevant concomitant medications. 
 
Relevant concomitant procedures. 
 
AEs (if within 30 days post an ablation procedure) and all SAEs. 
 
7.3. Monitoring Plan 
 
 
 
 
 
 
 
 
 
 
 
 
 
8. STATISTICAL CONSIDERATIONS
8.1. Statistical Design, Method and Analysis Procedure 
This is a single-arm, prospective, multicenter study designed to evaluate the efficacy and 
safety of the NeuWave Certus Microwave Ablation System in the treatment of Chinese patients 

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who have a single HCC tumor up to 5 cm or who have a maximum of 3 HCC tumors of up to 
3 cm per tumor. 
Categorical variables will be summarized descriptively by frequencies and associated 
percentages. Continuous variables will be summarized descriptively by number of patients, 
mean, standard deviation, median, minimum, and maximum. Confidence intervals will also be 
provided for procedure-related variables. A detailed Statistical Analysis Plan (SAP) describing 
all planned analyses of data collected in this study will be finalized prior to any analysis of data.  
There will be three analysis populations defined for summary of data collected in this study. 
The primary analysis of safety and effectiveness endpoints will be performed on the Full 
Analysis Set, defined as all patients who are enrolled in the study, are not part of the run-in 
phase, and have the NeuWave Microwave Ablation System used for ablation. A Per Protocol 
analysis set will be defined as all patients in the Full Analysis Set who have no major protocol 
deviations. Effectiveness analyses will be repeated for the Per Protocol Set. The Safety Set 
will include all patients who provide informed consent and have MW ablation attempted with 
the NeuWave system and includes run-in phase patients. The Safety Set will be used for 
summarization of safety endpoints only. Safety and effectiveness data collected o n patients 
participating in the run-in phase may be summarized separately from the remaining patients. 
There will be at least one planned subgroup analysis based on whether or not patients have a 
repeat ablation in the first 30 days to correct a margin (A1 to A0). A summary of all efficacy 
endpoints as well as adverse event summaries will be provided for all patients who only have 
the initial, planned ablation procedure at Visit 2A. These summaries will also be provided for 
all patients who receive a repeat ablation in the first 30 days.
The number and percentage of tumors achieving Technical Success will be summarized and 
a 95% confidence interval will be estimated. Technical Success will be evaluated based on 
the margin achieved after the first ablation and prior to any repeat ablations within the first 
7 days.  
A similar summary will be provided for Technical Efficacy. This endpoint will be based on 
the scan obtained at Visit 3 and will count as successes patients with A0 or A1 margins in 
that scan and who did not have an A2 margin since the Visit 2B scan. Additionally, if a 
patient received a repeat ablation for correcting a margin (to go from A1 to A0) within the 
first 30 days, this will also count as a success. Patients with repeat ablations to correct an 
A2 margin from Visit 2B to Visit 3 will not count as success for Technical Efficacy. The 
number and percentage of tumors with A0 and A1 margins will be presented as a sub-
categorization within each presentation of Technical Success and Technical Efficacy, as 
well as a summarization for the number and reasons for repeat ablations through Visit 3. 
Local tumor progression rates at 1, 3, 6, 9, 12, 18, 24, 30, and 36 months will be estimated 
using the Kaplan-Meier method and 95% confidence intervals will be provided. Any repeat 
ablation required after Visit 3 (Month 1) will be identified as an instance of local tumor 
progression. A similar summary will be provided for the 36-month overall and progression-
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The number and percentage of patients experiencing AEs will be summarized at the preferred 
term level using the Society of Interventional Radiology (SIR) clinical practice guidelines for 
event categorization. A similar summary will also be provided for device-related AEs, 
procedure-related AEs, all SAEs, device-related SAEs, and procedure-related SAEs. Adverse 
event rates will also be estimated using cumulative patient years of exposure as t he 
denominator as well as total number of patient ablations.  
Three analyses of study data are planned. The first will occur after all enrolled patients have 
completed the 1-month visit and is intended to provide an initial estimate of device 
effectiveness for Technical Success as well as to summarize the peri-operative out to 1-month 
post-operative safety profile of patients undergoing MW ablation. A similar analysis will occur 
after all patients have completed the 12-month visit and will include a summary of local tumor 
progression rates as well as safety through one year. There are no plans to use the results of 
either analysis for the purpose of stopping the study early. The third analysis will occur after 
all patients have completed study participation. 
8.2. Calculation of Sample Size 
8.2.1. Total Sample Size 
The total sample size will be 137 patients. This includes 3 patients at each site who will be part 
of the run-in phase. There are no stated hypotheses in this study from which a power 
calculation and sample size determination will be performed; rather, a minimum of 100 patients 
providing data to at least 1 year is determined to be sufficient to provide an evaluation of safety 
and effectiveness of the NeuWave Microwave Ablation System. In anticipation of up to 20% 
dropout, a total of 125 patients will be enrolled after completion of the run-in phase for a total 
of 137 patients.  
8.2.2. Minimum and Maximum Number of Patients in Each Clinical Trial Institution and 
Reasons for Determination 
No significance level is specified as no hypotheses are being tested in this trial, 
and therefore no determination of power is made.  
 
8.3. Expected Dropout Rate 
The expected dropout rate in this study is 20%. 
8.4. Criterion of Acceptability/Unacceptability of Clinical Trial Result
No specific hypotheses are identified from which an acceptability criterion is determined. 
Evaluation of acceptable performance of the NeuWave Microwave Ablation System will be 
made through a comprehensive evaluation of all data collected in this trial and put in context 
with other available therapies for HCC.  

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8.5. Criteria and Reason for Terminating the Trial based on the Statistical Results 
There are no planned analyses whose intent would be to stop the study early due to futility or 
superiority.  
8.6. 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 analyses will be performed only on patients undergoing ablation with the NeuWave 
Microwave Ablation System and only observed data will be analyzed. There will be no 
imputation of missing data for any parameters or for early terminated patients. At a given 
interim analysis time point, if a patient has not discontinued from the study, then the patient 
will be considered censored as of the date of the interim database lock for that analysis unless 
they have had an occurrence of the given endpoint prior to that interim database lock date. 
For time to event endpoints in the final analysis of data, patients who have not experienced an 
event will be considered censored at the last known visit date. 
8.7. Reporting Procedure of Deviation from Original Statistical Plan 
Any changes from the original planned statistical analyses will be specified in the protocol 
revisions, if applicable, and/or in a final or amended statistical analysis plan.  
8.8. Selection Criteria and Reason of Patients Included in the Analysis 
All patients that meet the inclusion/exclusion criteria are considered to meet the requirements 
for recruitment. Definitions of analysis sets are included in Section 8.1. 
 
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 questions and follow-up with the sites, as needed.  
When all patients 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. Likelihood Analysis of Success 
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 result from 

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its low risks of complications and high effectiveness in ablating tumors of the liver, lung, and 
kidney. Pre-clinical and clinical data has shown that MW ablation is safe and effective in liver 
tumors with low complication rates, high rates of technical success, lower rates of local tumor 
progression and promising disease-free and overall survival rates than have historically been 
reported for radiofrequency (RF).7 
The largest clinical experience using MW ablation to treat HCC comes from China, in part due 
to early adoption of MW ablation systems available in Asia. That multicenter study of 
1007 patients with primary liver cancer showed a technical success of 97.1% (1276/1363) and 
a local tumor progression rate of 5.9% (78/1363) with a mean follow-up time of 17.3 months 
(range, 3 to 68.9 months). The 1-, 3- and 5-year overall survival rates were 91.2%, 72.5% and 
59.8%, respectively.5 
Adoption of MW ablation systems has previously been limited by technical problems 
associated with suboptimal power handling, large antenna diameter, antenna shaft heating 
and unpredictable heating patterns. Despite these limitations, the results of clinical MW 
ablation studies have historically compared favorably with those of RF ablation. In recent years, 
MW ablation systems have advanced. The Certus Microwave Ablation System is a high-
powered, gas-cooled, multiple antenna-capable MW device, allowing physicians to realize the 
theoretical heating advantages of MW energy compared with other ablation modalities. 
Microwave ablation of HCC treatment is a minimally invasive procedure that may be performed 
in an outpatient setting and generally takes less than 2 hours for preparation and treatment. 
The patient is required to return to his or her study site for 9 follow-up visits over the course of 
3 years or until early discontinuation for reasons such as (but not limited to) withdrawal of 
consent, physician decision to withdraw the patient, lost to follow up, or death. 
10.2. Likelihood Analysis of Failure 
In a prospective study in China, the rate of major complications (3.8% of patients) was low and 
no deaths occurred within 30 days of ablation.6 To date, more than 400 units of the Certus 
Microwave Ablation System and Accessories have been sold in the United States, Canada, 
European Union, and Singapore, where thousands of patients have been successfully treated. 
In recent years, MW ablation is gaining momentum in China. Because of this growing 
popularity of MW, failure to meet total enrolment (137 patients) in approximately 8 months, as 
stipulated by the protocol, is unlikely. Also, because of the low rate of major complications in 
patients who have been treated with MW ablation, it is unlikely that the study will be 
discontinued because of safety concerns. 
 
11. DEVICE MANAGEMENT 
All devices must be stored in conditions according to product labeling and IFU. It is the 
responsibility of the Principal Investigator to ensure that devices are stored correctly at the 
sites.  
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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
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 unused study devices must be returned to 
Johnson & Johnson Medical (Shanghai) Ltd. with the appropriate study device return form.  
 
12. QUALITY CONTROL OF CLINICAL TRIAL 
During the clinical study, the Sponsor and investigator should execute their respective 
responsibilities according to the Good Clinical Practice for Medical Device Trials and 
applicable related Chinese and international regulations. They should also strictly follow the 
clinical trial protocol to ensure the quality of clinical trial.  
The Sponsor will ensure proper training on the clinical trial protocol and the use and 
maintenance of investigational medical device for all investigators participating in the trial, to 
ensure the consistency in the implementation of clinical trial protocol, the use of investigational 
medical device. 
During the implementation of study, the Sponsor is responsible for monitoring each phase of 
the clinical trial. The clinical monitor employed by the Sponsor or appointed representative 
should comply with the related standard operating procedure (SOP) and clinical trial protocol 
that are established by the Sponsor to monitor the clinical trial, to ensure the complete, 
accurate, true and reliable data. 
To ensure the quality of study, the Sponsor may authorize the eligible QA auditor to audit the 
clinical trial, as needed. The investigator should allow the auditors to review the original data 
and documents related to this study after receiving the notification. 
When the food and drug regulatory authority, competent department of health and family 
planning or other regulatory agencies send the inspection personnel to carry out the inspection, 
the clinical trial institution and investigator should cooperate and immediately notify the 
Sponsor. 
 
13. CLINICAL TRIAL ETHICAL ISSUES AND INFORMED CONSENT  
13.1. Ethical Concerns
Participating investigators will ensure that this protocol, the ICF, and if applicable, any protocol 
amendments or other written information provided to the patients that assist in the decision to 
participate are reviewed by an Institutional Review Board (IRB) or Ethics Committee (EC) that 
complies with governmental requirements. The approving IRB/EC will be responsible for the 
initial and continuing review and approval of this clinical investigation. Participating 

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policies. Additionally, investigators will be required to refrain from making any changes in the 
clinical investigation plan without Sponsor and IRB/EC approval of an amended protocol, 
except where necessary to eliminate apparent immediate hazards to study patients or others. 
Before the patients participate in the clinical trial, the investigator must fully explain this study 
and answer all questions raised by patients. Each patient (or legally authorized representative) 
must voluntarily sign and date the informed consent form (and other documents as per local 
regulations) that is approved by the Ethics Committee prior to implementing any study-related 
tests or procedures that are not SOC. The process of obtaining the informed consent needs 
to be clearly documented in the original record of the patient. The patient may request to 
withdraw the informed consent at any time during the study. This withdrawal will not affect the 
subsequent therapy of available / provided to the patient.
The production of investigational product should meet the relevant requirements of applicable 
quality management system for medical devices. The processing and storage of 
investigational product should meet the requirements of specifications and related standard 
operating procedure. The investigational product should be used according to the approved 
protocol and related operation instructions and IFU.  
The collection, use, and disclosure of all personal data (including the patient health and 
medical information) should comply with the applicable laws and regulations regarding the 
personal data protection and security. When collecting and processing such personal data, 
appropriate measures are to be taken to maintain the confidentiality of patient health and 
medical information and to prevent access by unauthorized persons. 
13.2. Approval of Trial Protocol 
The trial protocol should be internally 
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.
13.3. Process of Informed Consent and Text of Informed Consent Form 
13.3.1. 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 

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implementing any study-related items or operations not belonging to the standard treatment 
and after the nature of this study is fully clarified. 
The process of obtaining the written informed consent needs to prove that the patients 
volunteer to participate in this study. All aspects of this study must be clarified to the patients 
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 patients. 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.  
13.3.2. Text of Informed Consent Form 
The ICF is available as a separate attachment.
 
14. REGULATIONS OF ADVERSE EVENT AND DEVICE COMPLAINT 
REPORTING 
14.1. Adverse event 
An AE is defined as any undesirable clinical occurrence in a patient. All AEs, whether 
attributable to the device/procedure or not, are to be recorded in the eCRF and reported to the 
Sponsor. 
The investigator should determine whether an AE occurs and determine its relationship to the 
study device or surgery at each evaluation for the patients recruited for the clinical study. A 
change in severity may constitute a new reportable AE. 
All applicable AEs, study device faults and other product problems must be recorded in the 
medical record and entered in the 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: 
Mild: 
or is a transient event that resolves without treatment and with no sequelae. 
Moderate: 
. 
Severe: Incapacity with inability to do work or usual activities. 
It is the investigator
procedure. The following guidelines should be used in determining the relationship of an AE 
to a device, study procedure, or other causality: 
 
 

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the device belongs to or of similar device and procedure  
o The event has a temporal relationship with the device 
uses/application or procedures  
o The event involves a body-site or organ that  
 
The device or procedures are applied to  
 
The device or procedures have an effect on 
o The event follows a known response pattern to the 
medical device (if the response pattern is previously 
known)  
o The discontinuation of medical device application (or 
reduction of the level of activation/exposure) and 
reintroduction of its use (or increase of the level of 
activation/exposure), impact on the event (when clinically 
feasible)  
o 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  
o Harm to the patient is due to error in use  
o 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
defined terms below. An SAE/injury is an AE that results in one or more of the following for this 
study: 
 
 
 
Life-threatening illness or injury: The patient was 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 to enhance the ablative 
margin and for 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.

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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 study should not be reported as an SAE. 
2. 
SAE. The cause of death, however, should be 
reported as an SAE, except for progressive disease.  
3. Planned hospitalization for a pre-existing condition is not considered an SAE. 
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 (may also be known as a product complaint) is defined as any written, 
electronic or oral communication that alleges deficiencies related to the identity, labeling, 
quality, durability, reliability, safety, effectiveness, or performance of a device after it is 
released for distribution. A device complaint may or may not be associated with an AE/SAE.
Device complaints may include but are not limited to: 
 
Product contamination;
 
Defective components;
 
Poor packaging or product mix-up; 
 
Questionable stability; 
 
Device malfunction (the failure of a device to perform as intended for this study); 
Labeling concerns
 
User errors 
Device complaints must be reported to the Sponsor. If a Johnson & Johnson Medical 
(Shanghai) representative is made aware of a product complaint, the event should be reported 
retained if possible. Johnson & Johnson Medical (Shanghai) representatives will organize 
collection of the device for evaluation. 
The investigator should record all AEs and device deficiencies that occur during the clinical 
trial. The investigator should also work with the Sponsor to analyze the causes of the events. 
If needed, the written analysis report will be generated and present guidance pertaining to the 
continuation, discontinuation, or termination of the trial, and report to the administrative 
department responsible for clinical trials of medical devices. After reviewing the report, the 

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administrative department will forward the report to the Ethics Committee of the clinical trial 
institution for review. 
14.4. Reporting Procedure, Contact Information 
The investigator should provide the sufficient treatment for any AE of any patients, including 
the laboratory detection value with clinical significance whether or not it is related to this study. 
From ablation of the patient, all AEs related to the patient  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. 
All AEs and SAEs will be reported for 30 days after any ablation procedure (original or 
additional); after 30 days post an ablation procedure through the end of the study, only SAEs 
will be reported.  All AEs should be followed up, until the AE is resolved, stable or the study 
is completed. 
The investigator should record the nature, severity, treatment and outcome of the AE or SAE, 
and determine whether it is related to the study device, or the ablation procedure specified in 
the study protocol. 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 
 
(NMPA) (or designated person) immediately after being informed of the event. If required by 
the Sponsor, the further information should be provided. 
All SAEs need to be followed up until the event is resolved (with or without sequela). When 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 the further follow-up information. 
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 
h and Family Planning Commission within 5 work days 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 11 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: 

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Adverse events  
China AE reporting:  
Neuwave China AE Reporting@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
 

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15. DEVIATION FROM CLINICAL TRIAL PROTOCOL AND REGULATIONS 
FOR CLINICAL TRIAL PROTOCOL AMENDMENT 
The study protocol deviations are defined as the circumstances that fail to comply with the 
requirements of clinical trial protocol intentionally or unintentionally. 
All protocol deviations should be reported as protocol deviations to the Sponsor via the study 
EDC database. The reporting should include the date and reason for protocol deviations. The 
investigator should also report the protocol deviations to the EC and all related department 
according to each site  requirements and in combination with the requirements and 
procedures of the EC.  
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 major amendments must 
be approved by the Ethics Committee and regulatory authority (if needed) prior to 
implementing any changes to study procedures.
If an amendment likely has major impact on the following items, this amendment belongs to 
the major amendment: 
 
Safety or physical or mental health of patients; 
 
Scientific value of trial;
 
Implementation or management of trial; 
 
Quality or safety of investigational medical device specified in the trial. 
 
16. DIRECT ACCESS TO SOURCE DATA AND DOCUMENT 
The source data is defined as all information in the original record and its approved copy 
regarding the clinical findings, observations and other activities in the clinical trial, which can 
be used for reproduction and evaluation of clinical trial. The source documents are documents 
on which the source data is recorded, including printed, paper or electronic documents. 
The patient
medical record and other study related documents (source documents) must be 
maintained and retained by the investigator. The investigator should allow the monitors and 
auditors/inspectors to review all relevant patient records, including but not limited to the 
following information: 
 
Medical/physical condition of the study patient that meets the inclusion criteria prior to 
participating this study; 
 
Process of informed consent; 
 
Operational description of use and implantation of the study product; 

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All inspection results and follow-up; 
 
Examined printed output file or report (for example, X-ray film) that is dated and signed;
 
Description of AE and follow-up of AE (description of event, severity, date of occurrence, 
duration, correlation with the study device, study procedure, outcome, and treatment of 
the AE, concomitant medications when the AE occurs); 
 
Description of device complaint; 
 
Study patient
at the end of the study or withdrawn 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. 
Those patients that specifically consent to the additional research analysis will have relevant 
patient characteristics, treatment and outcome data, that is already being captured for this 
study, compiled with the same type of data from consenting patients from other NeuWave 
Medical studies used in a separate analysis. These data will be collectively used for Time and 
Power predictive analytics and reported in an aggregate fashion. Patient/patient identifiable 
information will not be 
. The goal of this analysis is 
to characterize the optimal MW ablation parameters for specific tumor types, locations, and 
liver conditions. 
 
17. FINANCES AND INSURANCE 
See the relevant study contract and insurance document. 
 
18. CONFIDENTIALITY 
The personal data of the patient participating in the trial is confidential; however, the Ethics 
Committee, NMPA, competent department of health and family planning, or the Sponsor and 
its authorized representative may review the personal data of the patient participating in the 
trial for the purpose of their work according to the local established procedure.
The personal data of the patient should be kept confidential during the entire period of clinical 
trial, and it should be ensured that the source data can be verified through the supporting 
information. A unique patient ID number (site number and patient number) will be used to 
identify all data for every enrolled patient. So long as the data is kept strictly confidential and 
that the privacy of the patient 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). 
 
 

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19. AGREEMENT ON THE PUBLICATION OF TRIAL RESULTS 
Following completion of this study, an article might be prepared and published in a scientific 
journal. No major results or experience from any individual site in this study can be published 
before the multicenter trial results are prepared and published. An exception to this rule will 
need prior approval from the Sponsor. A second publication may be generated by 
corresponding principal authors. The final analysis and review from all trial data are required 
to be reviewed and approved by the Sponsor. 
 
20. RESPONSIBILITIES THAT EACH PARTY SHOULD BEAR 
20.1. Responsibilities of the Sponsor
1) The Sponsor is responsible for the initiation, application, organization and monitoring of 
clinical trial. 
2) The Sponsor 
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 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 patients, 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. 

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20.2. 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 for clinical trial of medical device of clinical trial institution 
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 
 
7) 
 
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 patients, 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 patients. 
11) In case of an AE occurring in the clinical trial, the investigator should protect the safety of 
the patients 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 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 

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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 patients should be informed 
accordingly. It should be ensured that the patients 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.
20.3. 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) 
Date: DD/MM/YYYY 
 
Comments of investigator 
Signature 
Date: DD/MM/YYYY 
 
Comments of clinical trial institution of medical device 
 
Signature (Stamp) 
Date: DD/MM/YYYY 
 

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 APPENDIX 2: REFERENCES 
 
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NeuWave Medical, Inc. 
 
 
 

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