A Prospective Multicenter Study of Transbronchial Microwave Ablation Using Robotic-Assisted Bronchoscopy in Subjects With Oligometastatic Tumors in the Lung
Phase: NA
Conditions: Lung Neoplasms
Sponsor: Ethicon, Inc.

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A Prospective Multicenter Study of Transbronchial Microwave Ablation 
Using Robotic-Assisted Bronchoscopy in Subjects with Oligometastatic 
Tumors in the Lung 
 
Protocol Number: NEU_2020_03 
 
 
Document 
Effective Date 
Version 2.0 
18 August 2022 
Sponsor: 
NeuWave Medical, Inc. 
 
 
NeuWave Medical, Inc. is a subsidiary of: 
Ethicon, Inc. 
1000 US Highway 202 South 
Raritan, NJ 08869 
Name of Finished Product(s): 
NEUWAVETM FLEX MC Microwave Ablation 
System and Accessories 
Sub-products: 
NEUWAVETM FLEX Microwave Ablation 
System and Accessories 
Auris MONARCH® Platform 
 
 
CONFIDENTIALITY STATEMENT 
The information in this document contains trade secrets and commercial information that are privileged or 
confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. In 
any event, persons to whom the information is disclosed must be informed that the information is privileged 
or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally 
to all future information supplied to you which is indicated as privileged or confidential. 

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Sponsor Signature 
Protocol Number: 
NEU_2020_03 
Protocol Title: 
A Prospective Multicenter Study of Transbronchial Microwave 
Ablation Using Robotic-Assisted Bronchoscopy in Subjects 
with Oligometastatic Tumors in the Lung 
Version 2.0 Date: 
18 August 2022 

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

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TABLE OF CONTENTS 
1.0 
PROTOCOL SUMMARY ............................................................................................... 6 
2.0 
ETHICS .......................................................................................................................... 16 
3.0 
INTRODUCTION ........................................................................................................... 18 
4.0 
STUDY OBJECTIVES AND ENDPOINTS ..................................................................... 23 
4.1 
Primary Endpoint ................................................................................................ 23 
4.2 
Safety Endpoint .................................................................................................. 23 
4.3 
Secondary Endpoints ......................................................................................... 23 
4.4 
Exploratory Endpoints ........................................................................................ 24 
4.5 
Central Review Committee ................................................................................. 24 
4.6 
Additional Measurements/Data Collected .......................................................... 25 
5.0 
INVESTIGATIONAL PLAN ............................................................................................ 27 
5.1 
Overall Study Design and Plan – Description ..................................................... 27 
5.2 
Enrollment .......................................................................................................... 27 
5.3 
Inclusion Criteria ................................................................................................ 27 
5.4 
Exclusion Criteria ............................................................................................... 28 
5.5 
Prior and Concomitant Therapy ......................................................................... 30 
5.6 
Screen Failures .................................................................................................. 31 
5.7 
Removal of Subjects from the Study .................................................................. 31 
6.0 
STUDY PROCEDURES ................................................................................................ 33 
6.1 
Procedure Description(s) .................................................................................... 33 
6.2 
System Overview ............................................................................................... 36 
6.3 
Identity of Study Products .................................................................................. 37 
6.4 
Study Product Accountability .............................................................................. 37 
7.0 
STUDY VISIT SCHEDULE ............................................................................................ 39 
7.1 
Visit 1 – Screening ............................................................................................. 39 
7.2 
Visit 2 – Ablation Procedure Through Discharge ................................................ 40 
7.3 
Visit 3 – 30-day Follow-up .................................................................................. 42 
7.4 
Visit 4 – 3-month Follow-up ................................................................................ 43 
7.5 
Visit 5 – 6-month Follow-up ................................................................................ 43 
7.6 
Visit 6 – 12-month Follow-up .............................................................................. 44 

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7.7 
Unscheduled Visits ............................................................................................. 45 
8.0 
DATA MANAGEMENT AND INTEGRITY ...................................................................... 46 
8.1 
Data Completion and Record Keeping ............................................................... 46 
8.2 
Medical Dictionary Coding.................................................................................. 48 
8.3 
Data Quality Assurance ..................................................................................... 48 
9.0 
DEVIATIONS FROM THE PROTOCOL ........................................................................ 50 
10.0 
STATISTICAL METHODOLOGY ................................................................................... 51 
10.1 
Statistical and Analytical Plans ........................................................................... 51 
10.2 
Study Design ...................................................................................................... 51 
10.3 
Ablation Assignment .......................................................................................... 51 
10.4 
Interval Windows ................................................................................................ 51 
10.5 
Primary Endpoints and Associated Hypotheses ................................................. 51 
10.6 
Levels of Significance ......................................................................................... 51 
10.7 
Analysis Sets ...................................................................................................... 51 
10.8 
Sample Size Justification ................................................................................... 52 
10.9 
Analyses to be Conducted ................................................................................. 52 
11.0 
RISKS AND BENEFITS OF THE STUDY ...................................................................... 55 
12.0 
ASSESSMENT OF SAFETY ......................................................................................... 58 
12.1 
Adverse Events .................................................................................................. 58 
12.2 
Reporting Adverse Events ................................................................................. 61 
12.3 
Data Safety Monitoring Board ............................................................................ 62 
13.0 
PRODUCT COMPLAINT DEFINITION .......................................................................... 64 
14.0 
TRAINING ...................................................................................................................... 65 
15.0 
DATA AND PUBLICATION POLICIES .......................................................................... 66 
16.0 
SUPPLEMENTS ............................................................................................................ 67 
16.1 
Appendix 1: Numeric Pain Rating Scale ............................................................ 67 
16.2 
Appendix 2: Nashville Scale for Bleeding .......................................................... 68 
16.3 
Glossary ............................................................................................................. 69 
17.0 
SCIENTIFIC REFERENCES ......................................................................................... 72 
 

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1.0 
PROTOCOL SUMMARY 
 
Full Title 
A Prospective Multicenter Study of Transbronchial Microwave 
Ablation Using Robotic-Assisted Bronchoscopy in Subjects with 
Oligometastatic Tumors in the Lung 
Protocol Number 
NEU_2020_03 
Short Title 
POWER Study 
(Prospective 
Transbronchial 
Microwave 
+ 
Robotic-Assisted 
Bronchoscopy) 
IDE Number 
G210303 
Sponsor 
NeuWave Medical, Inc. 
Study Objective 
The primary objective of the study is to evaluate the safety and 
effectiveness of the NEUWAVETM FLEX MC Microwave Ablation 
System and Accessories used in transbronchial ablation procedures 
for adult subjects with oligometastatic tumors (< 2cm) in the lung. 
Study Devices 
NEUWAVETM 
FLEX 
MC 
Microwave 
Ablation 
System 
and 
Accessories 
Sub-products: 
• NEUWAVETM 
FLEX 
Microwave 
Ablation 
System 
and 
Accessories 
• Auris MONARCH® Platform 
Study Design 
Prospective, multicenter, single-arm study 
Study Population 
Adult subjects with oligometastatic tumors (< 2cm) in the lung, 
located in the outer two-thirds and not closer than 1cm to the pleura 
(including fissures), with colorectal, renal, or sarcoma histologies. 
Potential Geographic 
Areas to be Included 
United States, Hong Kong, Canada, and China 
Anticipated Study 
Timelines 
Enrollment: 2 years 
Follow-Up: 1 year 
Sample Size 
Up to 145 subjects ablated 
Procedure Description 
Transbronchial microwave ablation will be performed using the 
NEUWAVETM FLEX Microwave Ablation System and Accessories 
on oligometastatic tumors in the peripheral lung, guided by the Auris 
MONARCH® Platform for visualization and access while using cone 
 
 

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beam CT (computed tomography) to confirm probe tip placement 
and final ablation zone. 
Primary Endpoint 
Technique Efficacy: Ablation of the target tumor(s) with the ablation 
zone completely overlapping or encompassing the entire target 
tumor(s) using CT imaging at 30 days (-7 to +14 days) post the 
original ablation procedure. 
Safety Endpoint 
Adverse events (AEs) will be assessed from the time of subject 
consent. 
• Perioperative AEs will be captured from the time of subject 
consent through 30-days post any ablation procedure (i.e., the 
original ablation as well as any re-ablation) regardless of 
relationship to the study device or procedure. 
• AEs that are deemed related to the study device or procedure 
will be captured 30-days post any ablation procedure (i.e., the 
original ablation as well as any re-ablation) through the end of 
the study or early discontinuation. 
• Serious adverse events (SAEs) will be captured from the time of 
subject consent through the end of the study or early 
discontinuation regardless of relationship to the study device or 
procedure. 
Secondary Endpoints 
• Technical Success: All A0 and A1 ablation classification 
determinations (complete tumor ablation with a surrounding 
minimal margin) as assessed by cone beam CT imaging, 
immediately following the ablation procedure. 
• Navigational Success: Successful navigation to the targeted 
peripheral lung tumor(s) as confirmed using cone beam CT 
(CBCT). 
• Local Tumor Progression (LTP): Recurrence of originally ablated 
target tumor(s) within or abutting the ablation zone using 30-day 
post-ablation imaging as the baseline. 
• Local Tumor Progression Free Survival (LTPFS): Time from the 
ablation until local tumor(s) progression (LTP) or death, 
whichever occurs first. 
• Progression Free Survival: Time from the original ablation until 
tumor(s) progression or death, whichever occurs first (includes 
local, regional, or distant progression). 
• Disease (cancer) Specific Survival: Time from the original 
ablation until death from the treated primary malignancy. 
• Overall Survival: Time from the original ablation until subject 

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death (includes death from any cause). 
• Repeat Ablation Efficacy Rate: Rate of original tumors that have 
been re-ablated successfully (i.e., Technical Success of tumors 
that have been re-ablated/all original tumors that have been re- 
ablated). 
• Change in all available PFTs (pulmonary function tests) from 
pre-ablation baseline values to values at 3 months, 6 months, 
and 12 months post-ablation. 
• Change in overall health-related quality of life (HRQOL) and sub- 
scales, including physical functioning and pain domains, per the 
validated EORTC QLQ-C30 and QLQ-LC13 questionnaires 
throughout the duration of the study. 
Exploratory Endpoints 
• Level of Procedure Related Pain: Subject reported outcome 
determined by the Numeric Pain Scale. 
• Subject functionality as measured by distribution of Eastern 
Cooperative Oncology Group (ECOG) classification scores over 
time. 
• Hospital Readmission Rate: Any unplanned admission or re- 
admission to the hospital within 30 days of the ablation 
procedure due to an adverse event. 
• Procedural cost (UB-04). 
• Number of systemic chemotherapy-free days from time of 
ablation through the duration of the study. 
Inclusion Criteria 
1. Signed informed consent. 
2. Subjects > 22 years old. 
3. Performance status 0-2 (Eastern Cooperative Oncology Group 
classification [ECOG]). 
4. Willing to fulfill all follow-up visit requirements. 
5. Subjects with no more than five oligometastatic tumors in no 
more than three organ sites with no more than three tumors 
in any single organ. 
6. Presence of at least one oligometastatic lung tumor with 
colorectal, renal, or sarcoma histology where the primary tumor 
is controlled (in the opinion of the investigator or treating 
oncologist). Histology should be documented by the following 
criteria: 1) biopsy of target lesion, if feasible, or 2) imaging 
highly suspicious for metastatic lesion in context of a previous 
biopsy of the primary or other metastases. 
7. Oligometastatic lung tumor(s) planned to be ablated should be 
< 2cm (based on the Screening Visit image), in the outer two- 
thirds of the lung, and not closer than 1cm to the pleura 

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(including fissures) or contiguous with the pleura. The outer 
two-thirds is defined as beyond the segmental airway, such 
that proximal endobronchial soft tissue tumors are avoided. 
Exclusion Criteria 
1. Pregnant or breastfeeding. 
2. Subjects 
with 
thoracic 
implantable 
devices, 
including 
pacemakers or other electronic implants. 
3. Chronic, continuous ventilator support, which uses bi-level 
positive airway pressure (PAP) to improve lung function for 
severe conditions. (However, intermittent PAP, for non- 
pulmonary conditions, such as sleep apnea, is permitted). 
4. Prior pneumonectomy. 
5. Severe bronchiectasis (with FEV1 <30%) or disease deemed 
to be too severe in the opinion of the investigator. 
6. Clinical or imaging findings consistent with an active 
pulmonary infection. 
7. Platelet count ≤ 50,000/mm3. 
8. Subjects with uncorrectable coagulopathy at time of screening. 
9. Subjects medically unable to stop anti-platelet agents (e.g., 
aspirin, clopidogrel, prasugrel, ticagrelor) at least 5 days prior 
to the procedure through 48-72 hours after the procedure. 
10. Subjects medically unable to stop warfarin at least 3-5 days 
prior to the ablation procedure, or until INR < 1.5, through 48- 
72 hours after the procedure. On the day of the procedure, 
subjects with an INR > 1.5 cannot have the procedure 
completed that day but may be rescheduled or postponed. 
11. Subjects medically unable to stop anticoagulants (e.g., 
rivaroxaban, apixaban, dabigatran, endoxaban) at least 3 days 
prior to the ablation procedure through 48-72 hours after the 
procedure. 
12. Subjects who require heparin or low molecular weight heparin 
bridging. 
13. Expected survival less than 6 months, in the opinion of the 
investigator and/or treating oncologist. 
14. Subjects with known or suspected brain metastases. 
15. Subject has had any radiation (i.e., SBRT or EBRT) to the 
intended ablation zone. 
16. Endobronchial tumors proximal to and including the segmental 
airways. 
17. Tumors where the anticipated zone of ablation would 
encompass significant (in the opinion of the treating physician) 
emphysematous or bullous disease. 
18. Subject who underwent lung ablation, surgical resection 
therapy, radiotherapy, or any other treating procedure within 
30 days prior to the planned study ablation procedure or those 
who plan to receive a lung ablation, surgical resection, or 

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radiation therapy on the ablated lung side before completing 
the primary endpoint assessment (30 days post-ablation). 
19. Subject who received systemic therapy (e.g., chemotherapy, 
targeted drug therapy, or immunotherapy) within 14 days prior 
to the planned study ablation procedure or those who plan to 
receive systemic therapy before completing the primary 
endpoint assessment (30 days post-ablation). 
20. Uncontrolled hypertension pre-procedure (Visit 2). Defined as 
systolic blood pressure ≥ 160mmHg and/or diastolic blood 
pressure ≥ 100mmHg despite pharmacotherapy. 
21. Subjects who have participated in an investigational drug or 
device research study within 30 days of enrollment that would 
interfere with the primary endpoint of this study. 
22. Physical or psychological condition that would impair study 
participation. 
23. Severe neuromuscular disease. 
24. Subjects judged unsuitable for study participation by the 
Investigator for any other reason. 
Intra-operative exclusion criteria that lead to stopping a procedure: 
25. Inability to tolerate anesthesia. 
26. Time of navigation to initiation of ablation longer than 60 
minutes, per target tumor. 
27. Bleeding estimated to exceed 50cc (visualization via the 
drainage system) or a Nashville grade 2 or higher intervention 
is required (see Appendix 2). 
28. If the CBCT imaging after a bleeding episode obscures the 
radiographic visibility of the tumor such that the ablation 
probe/tumor relationship is not discernable, the procedure 
should be terminated. 
29. Any presenting condition discovered intra-procedurally that in 
the opinion of the Investigator would make participating in this 
study not in the subject’s best interest. 
DSMB (Data Safety 
Monitoring Board) 
An independent Data Safety Monitoring Board (DSMB) will be 
commissioned to periodically review safety events from the study to 
ensure safety trends are consistent with the current safety profiles 
of the devices. 
Specifically, a report of death or severe hemorrhage requiring 
intervention beyond local therapy (i.e., Nashville > grade 2 or 
CTCAE > grade 2) within 30 days of an ablation procedure will 
temporarily stop enrollment and require review by the DSMB. 
Statistical Analyses 
The number and percentage of tumors achieving Technique Efficacy 
will be summarized and a confidence interval will be estimated. 

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Technical Success, Repeat Ablation Efficacy, and Hospital 
Readmission Rate will be summarized in a similar manner. Local 
Tumor Progression, Local Tumor Progression Free Survival, 
Progression Free Survival, and Overall Survival will be estimated 
using the Kaplan-Meier method and confidence intervals will be 
provided. 
The number and percentage of subjects experiencing device-related 
AEs will be summarized by the MedDRA system organ class and 
preferred term. A similar summary will also be provided for 
procedure-related AEs and all SAEs. 
Summary statistics will be provided for all other endpoints as defined 
within the protocol. 
Interim Analyses 
The first interim analysis will occur after 20 subjects complete Visit 
3 (30 days) and will be descriptive in nature only and will not impact 
the final analysis. 
The second interim analysis will occur after all subjects complete 
Visit 3 (30 days) and will include an evaluation of the primary 
endpoint against the performance goal as well as provide a 
summary of all baseline and procedural-related data. A complete 
summary of all safety-related data observed through the duration of 
follow-up on all subjects will also be provided. The intent of this 
analysis will be to support regulatory filing activities where 
appropriate. 
An additional interim analysis may be performed after all subjects 
have completed Visit 5 (6 months). 
The final analysis will be completed once all subjects have 
completed Visit 6 (12 months) and will summarize all endpoints 
collected during the trial. 
Time and Events 
Schedule 
See Table 1 on the next page. 

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4. Only for women of childbearing potential. Tested per site SOC (urine or serum) if/when applicable. 
5. Coagulation tests, including APTT and PT/INR, per site SOC. 
6. INR should be one of the first assessments completed on the ablation day to ensure it is < 1.5 or the ablation should be rescheduled. Other 
assessments, if completed, do not need to be repeated as long as the ablation is completed within two weeks of the originally scheduled ablation. 
7. Data for any serum-based tumor markers (e.g., CEA and LDH) or molecular profiling, if completed as part of SOC. 
8. Quality of Life questionnaires include the validated European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the 
lung-specific QLQ-LC13. These questionnaires should be administered in person, during the study visit. However, they may be administered over 
the phone, when needed, using the Sponsor-provided script. 
9. Ablation procedure details include, but are not limited to, the following: date and time of procedure, anatomical location of ablations, number of 
ablation cycles, time and power used for each ablation, number of cone beam CT scans performed for probe placement and margin assessment, 
number of probe placement attempts per ablation, type of probe(s) used, type of anesthesia, duration of procedure (the time when the bronchoscope 
enters the endotracheal tube to the time when the last cone beam CT scan is taken) and radiation exposure from CBCT scans and the entire 
procedure. 
10. Contrast-enhanced is preferred for these CT images (chest, abdomen, and pelvis), but not required. 
11. CT scan of the chest is used at Screening to determine tumor details (e.g., size, location, and type, if available). Tumor size must be measured in 
3 axes (axial, sagittal, and coronal). 
12. CT scan of the chest is used at every follow-up visit to determine tumor details (e.g., size and location) and to assess local tumor control. If PET 
(positron emission tomography) scan is taken during follow-up as part of SOC, the site must also perform the diagnostic CT as per protocol. 
Technique Efficacy and Local Tumor Progression will be determined based on image analysis. 
13. The abdomen and pelvis CT required at Screening does not have to be repeated if a previous abdomen and pelvis CT was complete d within 90 
days of the visit. 
14. Brain MRI (with or without contrast) is preferred to be completed at requested timepoints (Screening and Visits 4, 5, and 6), but is not required, and 
should be taken per site SOC. A brain MRI may be included as part of the Screening imaging if it was completed within 12 months of the visit. 
15. For patients with an extremity sarcoma, extremity CT or MRI (with or without contrast) is preferred to be completed at requested timepoints 
(Screening and Visits 4, 5, and 6), but is not required, and should be taken per site SOC. An extremity CT or MRI may be included as part of the 
Screening imaging if it was completed within 90 days of the visit. 
16. Measure and record the size of the tumor(s) on the day of ablation using CBCT. Afterwards, use cone beam CT to guide the microwave ablation 
probe to the target tumor(s) and ascertain the location of the probe after the robotic bronchoscope has been retracted. CBCT scans will be used 
at a minimum of three timepoints pre- and post- the ablation process: (1) Pre-Navigation: Prior to starting navigation, CBCT will be used to establish 
baseline imaging, confirm tumor details, and tumor segmentation for navigation (i.e., augmented fluoroscopy), (2) Pre-Ablation: Immediately before 
the ablation, use CBCT to confirm that the probe is in the intended location, and if it is not, reposition the probe, and (3) Post-Ablation: After 
completing the ablation, use CBCT to confirm that the ablation margins are adequate. Note: Technical Success will be determined based on CBCT 
image analysis. 
17. Perioperative AEs will be captured from the time of subject consent through 30-days post any ablation procedure (i.e., the original ablation as well 
as any re-ablation) regardless of relationship to the study device or procedure. AEs that are deemed related to the study device or procedure will 

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be captured 30-days post any ablation procedure (i.e., the original ablation as well as any re-ablation) through the end of the study or early 
termination. SAEs will be captured from the time of subject consent through the end of the study or early discontinuation regardless of relationship 
to the study device or procedure. 
18. UB-04 data collection is applicable for US sites only. 
19. Length of hospital stay (LOS), measured from post-ablation to discharge. After the ablation procedure, the subject will be observed for up to 23 
hours before discharge, except in cases where the Investigator deems it is necessary for the subject to remain hospitalized. 
20. Record readmission to any hospital for any unplanned reason within 30 days of any ablation procedure (i.e., the original ablation as well as any re- 
ablation). The Investigator will assess the reason for the admission and capture the reason in the clinical database. 
21. Record reason for unscheduled visit, as well as AEs (if applicable), and any updates to concomitant medications, concomitant procedures, or any 
other study assessments, per site SOC. 

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2.0 
ETHICS 
Institutional Review Board/Ethics Committee 
Participating investigators will ensure that this protocol, Informed Consent Form (ICF), and if 
applicable, any protocol amendments or other written information provided to the subjects who 
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 investigators will be required to promptly report new protocol amendments and new 
ICFs to the IRB/EC as required by the IRB/EC’s policies. Additionally, investigators will be required 
to refrain from making any changes in the clinical investigation plan without Sponsor and IRB/EC 
approval of an amended protocol, except where necessary to eliminate apparent immediate 
hazards to study subjects or others. 
Applicable Regulations 
This study will be conducted in compliance with Good Clinical Practice and in accordance with the 
Declaration of Helsinki, as well as any other applicable local and country regulatory requirements. 
Subject Information and Consent 
Regulations concerning the protection of subjects require that informed consent be obtained before 
a subject may participate in any clinical investigation. Screening assessments that are part of 
standard-of-care (SOC) may occur prior to consent; however, the data may not be collected for 
study purposes until the ICF has been signed by the subject. 
An IRB/EC approved informed consent must be sought from each subject and must be 
appropriately documented in the subject’s medical record prior to initiating the study. It is the 
Investigator’s responsibility to obtain written informed consent from the subject, however, the 
Investigator may delegate this responsibility if appropriately documented. 
The informed consent process involves the following: giving a subject adequate information 
concerning the study, providing adequate time for the subject to consider all available options, 
responding to the subject’s questions, ensuring that the subject has comprehended this information 
and finally, obtaining the subject’s written consent to participate in this study. All subjects in this 
study should be completely informed about the purpose, risks, benefits, and other pertinent details 
of this study. The informed consent process is careful to avoid the perception of any coercion or 
undue influence on, or inducement of, the subject to participate, and does not waive or appear to 
waive the subject's legal rights. The ICF is presented in native, non-technical language that is 
understandable to the subject. 
Prior to a subject’s participation in this study, an ICF will be signed and dated by the subject and 
person who conducted the consent discussion. The subject will be provided a copy of the signed 
ICF. The ICF and any other written materials provided to the subject to assist in the decision to 
participate must be revised whenever new information becomes available that may be relevant to 
their willingness to participate or continue participation in this study. Revision to the ICF and other 
written materials will receive IRB/EC approval before implementation. Each subject will be required 
to sign any amended ICF (as required by the IRB/EC) and will receive a copy of the signed ICF. 

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Administrative Requirements 
This study is sponsored by NeuWave Medical, Inc. and will be conducted under a single protocol 
approved by each participating site’s IRB/EC prior to implementation. The principal investigator 
must be either an interventional pulmonologist or thoracic surgeon qualified by education, 
experience, and training to perform the study procedure and to assume responsibility for the 
conduct of this study. 
The Data Management and Biostatistics groups of NeuWave Medical, Inc. will be responsible for 
the analysis of data from this protocol. An electronic data capture (EDC) system will be utilized by 
study site personnel to transfer study data from source records (the first point of clinical data 
capture) onto common electronic case report forms (eCRFs). This system is a web-based, secure 
electronic software application 
 
 
 This system was designed and is developed and maintained by 
 in a 
manner that is compliant with national and international Good Clinical Practice (GCP) data 
protection/data privacy and electronic record/electronic signature (e.g., 21 CFR Part 11) regulatory 
requirements. 
Protocol Modifications 
All protocol amendments must be issued by the Sponsor, signed and dated by the Investigator, 
and should not be implemented without prior IRB/EC approval, except where necessary to 
eliminate immediate hazards to the subjects or when the change(s) involves only logistical or 
administrative aspects of the study (e.g., change in monitor(s), change of telephone number). The 
Investigator reports the protocol amendments to the site’s IRB/EC as per their local requirements. 

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3.0 
INTRODUCTION 
Oligometastatic lung tumors & rationale for local control 
A subset of subjects with metastatic malignancy will present with a limited number of metastases 
and a low burden of disease. This intermediate state between localized cancer and widely 
metastatic disease – so-called oligometastatic disease state – occurs in a variety of primary tumor 
types, with colorectal carcinoma, renal cell carcinoma, and soft tissue sarcoma being the most 
common.1 Oligometastatic disease is most commonly defined as having up to five sites of 
metastasis from a primary tumor with a maximum of three metastases in any one organ.2 The 
lungs are a frequent site of oligometastatic disease.3,4 While palliative systemic chemotherapy is 
the standard for subjects with widely metastatic disease, local therapies are the preferred treatment 
approach for subjects with oligometastatic disease. 
The rationale for local therapy in this population is that aggressive treatment (e.g., surgery, SBRT) 
of the demonstrable sites of disease may result in a prolonged disease-free state. In addition, local 
therapy may obviate the need for systemic chemotherapy and its associated toxicity. This strategy 
has traditionally involved surgical resection, with the hope that removing all local sites of disease 
would result in an improved survival. However, robust clinical evidence to support improvements 
in survival are lacking. Observational studies in subjects undergoing surgical metastasectomy have 
noted improved survival, although subject selection bias remains a possible explanation for these 
findings.5,6 Another study highlighted the potential benefit of local control by noting a significant 
improvement in overall survival (OS) between those subjects who achieved a complete resection 
compared to those where only an incomplete resection was possible (36% OS at 5 years vs. 13% 
OS at 5 years).2 On the other hand, the only randomized trial of surgical metastasectomy 
compared to standard of care therapy in subjects with pulmonary metastases from colorectal 
carcinoma demonstrated no survival benefit.7 Nonetheless, these studies have led to the increased 
adoption and acceptance of local therapy as the preferred treatment strategy in subjects with a 
limited number of metastatic lesions. 
Survival outcomes do not vary by modality used to achieve local control 
Although local control of metastases has generally been accomplished with surgical resection, 
many subjects are not candidates for surgery, and non-surgical approaches to local therapy are 
increasingly employed. In the lung, stereotactic body radiation therapy (SBRT) and image-guided 
thermal ablation (IGTA) are currently available. Similar to surgical metastasectomy, studies 
suggest/show there is no evidence of a survival benefit across these non-surgical treatment 
modalities. The Sponsor’s ongoing systematic review and meta-analysis examining outcomes in 
subjects with pulmonary metastases treated with SBRT or IGTA has identified a total of 21 studies 
[restricted to studies with at least 40 subjects]. The 1-year progression free survival (PFS) rate of 
these options was found to be similar; 58% (95% CI:49%-67%) for IGTA and 60% (95%CI:52%- 
67%) for SBRT. Published literature has also demonstrated similarity in survival outcomes between 
these approaches: a published meta-analysis demonstrated similar outcomes for IGTA and SBRT 
with 3 years OS around 45-65% for these options.8 These results are similar to the outcomes seen 
in surgical series, with reported 3 years overall survival of 40-60%.9,10 As a result, several clinical 
guidelines have suggested that surgical resection, ablation, or SBRT may all be considered for 
local treatment of pulmonary metastases.11,12 

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Transthoracic ablation as a treatment modality in oligometastatic subjects 
Given the lack of data supporting a survival advantage of one therapeutic modality over another, 
the benefit-risk profile of all available options must be considered. The clinical decision to pursue 
one therapeutic modality over another is complex and dependent on lesion location, size, 
underlying comorbidities, pulmonary function, estimated success at achieving local tumor control, 
anticipated short- and long-term adverse events, and impact on physical functioning, pain, and 
health-related quality of life. As a result, shared decision making and subject preference become 
critical factors in the clinical decision. Several studies have demonstrated that subjects with 
metastatic malignancy prefer therapies that minimize the impacts on their health-related quality of 
life (e.g., pain, adverse events, functioning) and which may preclude the need for systemic 
chemotherapy.13,14,15 Percutaneous ablation is a minimally invasive, out-patient procedure that has 
demonstrated efficacy in the treatment of pulmonary metastases, with high rates of complete tumor 
ablation (>90%) and subsequent local tumor control (>85%).16 In addition, subjects treated with 
percutaneous ablation experience minimal impact on health-related quality of life, particularly as it 
pertains to physical functioning, role functioning, pain, and fatigue.17,18,19 As a result, percutaneous 
ablation is increasingly used in the treatment of pulmonary oligometastatic disease and there is 
equipoise in the clinical guidelines between surgery, SBRT and IGTA.11,20,21 
Transbronchial microwave ablation (MWA) 
While radiofrequency ablation (RFA) was historically the most commonly used ablative modality 
for percutaneous lung ablation, microwave ablation (MWA) is now the preferred option. This is 
largely due to MWA’s ability to create larger, more uniform ablation zones in a shorter period of 
time as a result of MWA’s improved ability to propagate through and heat high impedance lung 
tissue and less susceptibility to vascular “heat sinks”.22 While the percutaneous approach to MWA 
has been more widely adopted, the transbronchial approach offers potential advantages including 
a lower risk of pneumothorax, bleeding, and other pleural based complications such as pleural 
effusion, empyema, and bronchopleural fistula. A few pilot studies have tested the feasibility of 
this approach.23 The largest of these reports included 25 subjects with mixed primary non-small 
cell lung cancer (NSCLC) and oligometastatic lesions to the lung who were considered poor 
surgical candidates or opted out of surgery.24 In this single center retrospective experience, 30 
lesions (≤ 3cm) in 25 subjects were treated. Pneumothorax requiring a chest tube was reported in 
2 subjects (6.7%), Grade 1 hemoptysis and an infected pleural effusion in 1 subject each. One 
death was reported at 12 months deemed unrelated to the procedure. During a median follow up 
of 1 year, no progressive disease was identified. 
The Sponsor has also conducted a prospective pilot study using the NEUWAVETM FLEX 
Microwave Ablation System and flexible probes in combination with electromagnetic navigational 
bronchoscopy (NCT03603652).23 This study enrolled 10 subjects with primary NSCLC who either 
refused surgery or were deemed to be poor surgical candidates. Subjects underwent image guided 
ablation of their target lesion (≤ 2cm). The primary endpoint of technique efficacy was judged by 
the treating physician to have been achieved in all cases, and over 1 year of follow up, 1 subject 
was deemed to have had a recurrence of their disease. No pneumothoraces were reported in this 
study. Two subjects died during the study, 1 of which was periprocedural and was deemed to be 
probably related to the procedure. In this case, navigation to the lesion was prolonged and bleeding 
was observed during the navigation. The subject died 2 weeks later of a presumed pulmonary 
hemorrhage though no autopsy was performed. While the DSMB stated the study could continue 

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with protocol modifications, the Sponsor stopped the study to update the study design based on 
feedback from the DSMB and FDA and to re-start the study under an Investigational Device 
Exemption (IDE) protocol. 
Robotic Assisted Transbronchial Ablation: 
The Sponsor has since combined the precision of robotic-assisted bronchoscopy (RAB) with the 
efficiency of microwave ablation into a single system called the NEUWAVETM FLEX MC Microwave 
Ablation System and Accessories (i.e., “FLEX MC”), which is planned to be used in the current 
study (see Section 6.2 of protocol). Conceptually, combining the micro-precision and direct 
visualization of RAB would allow for more precise placement of ablation probe, ideally in the center 
of the lesion, which could lead to fewer ablations needed to obtain the desired ablation zone. In 
support of this concept, several studies have noted a higher rate of nodule localization with RAB 
compared to other peripheral bronchoscopy techniques. The BENEFIT trial evaluating the 
Monarch platform noted a lesion localization rate of 96%.25 With traditional bronchoscopy, studies 
evaluating versions of the electromagnetic navigation using a variety of platforms have noted 
localization rates ranging from 81.2% to 88.1%.26,27 This improved precision and accuracy of 
navigation is likely to lead to reduced procedural times, as the often time-consuming process of 
probe repositioning prior to ablative therapy should be reduced. 
The RAB used in this study will be the MONARCH® Platform 
 
 which is 510K cleared (K211493) in the United States for both diagnostic and therapeutic 
procedures (i.e., “MONARCH Platform”). The safety of this platform has been studied in a number 
of clinical studies as well as in the post marketing setting with over 9,500 procedures performed to 
date. 
The MONARCH Platform was first tested in a clinical feasibility study of 15 subjects.28 In that study, 
robotic bronchoscopy to access the periphery of the lung was technically feasible, and it resulted 
in no serious adverse events and no procedure- or device-related complications. An additional 
clinical study was completed looking at the feasibility of using MONARCH in subjects (n=55) with 
peripheral pulmonary lesions. Results from this study showed a safety profile of the robotic- 
assisted bronchoscopy to be comparable with conventional transbronchial biopsy. The robotic 
platform successfully localized approximately 96% (51/53) of lesions, and pneumothorax was 
reported in 2/54 (3.7%) of cases, requiring tube thoracostomy in 1/54 (1.9%) case.25 No additional 
adverse events were reported. In addition, the Sponsor has an ongoing 1,200 patient prospective, 
observational study (the TARGET study) to further characterize the diagnostic performance of the 
MONARCH Platform in transbronchial biopsies of pulmonary nodules (NCT04182815). 
The NEUWAVE FLEX Microwave Ablation System (NeuWave Medical, Inc., Madison, WI) will be 
paired with the MONARCH Platform, and studied under this protocol as “FLEX MC” under an IDE 
issued by the FDA. 
Transbronchial ablation of lung tumors will involve a physician operator using the MONARCH 
Platform to provide bronchoscopic visualization and access to targeted lung tumors before 
precisely placing the FLEX probe into the desired anatomical location manually via the working 
channel (lumen) of the MONARCH bronchoscope. Once the FLEX probe is precisely positioned, 
the physician operator can then ablate for up to several minutes until the targeted lung tissue is 
treated. The MONARCH Platform enables precise control and stability of a flexible bronchoscope 

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under continuous and direct control by a physician operator, while allowing for continuous real- 
time visualization of targeted lung anatomy throughout the procedure. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Conclusion 
FLEX MC has the potential to fill an unmet need as an effective, precise, repeatable, minimally 
invasive local therapy option that preserves physical function and health-related quality of life in 
subjects with oligometastatic disease. By leveraging the safety advantages of bronchoscopy 
relative to percutaneous access with regards to pneumothorax and other pleural based 
complications, FLEX MC has the potential to offer subjects the benefits seen with transthoracic 
ablation with an improved risk profile. The proposed study will evaluate the benefit risk profile of 
FLEX MC in a population of subjects with oligometastatic tumors in the lung. 

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4.0 
STUDY OBJECTIVES AND ENDPOINTS 
The primary objective of the study is to evaluate the safety and effectiveness of the NEUWAVETM 
FLEX MC Microwave Ablation System and Accessories used in transbronchial ablation procedures 
for adult subjects with oligometastatic tumors (< 2cm) in the lung. 
In this study, “target” tumors are defined as lung tumors that are treated with FLEX MC at the index 
ablation procedure (i.e., Visit 2). A subject may have a maximum of two target tumors. “Non- 
target” tumors are defined as lung tumors that are treated with FLEX MC during study follow-up 
after completion of the primary endpoint, Technique Efficacy assessments at Visit 3 (i.e., Visits 3- 
6). A subject may not have more than three total tumors treated with FLEX MC (including target 
and non-target tumors). 
4.1 Primary Endpoint 
• Technique Efficacy: Ablation of the target tumor(s) with the ablation zone completely 
overlapping or encompassing the entire target tumor(s) using CT imaging at 30 days (-7 
to +14 days) post the original ablation procedure. 
4.2 Safety Endpoint 
• Adverse events (AEs) will be assessed from the time of subject consent. 
o Perioperative AEs will be captured from the time of subject consent through 30-days 
post any ablation procedure (i.e., the original ablation as well as any re-ablation) 
regardless of relationship to the study device or procedure. 
o AEs that are deemed related to the study device or procedure will be captured 30- 
days post any ablation procedure (i.e., the original ablation as well as any re- 
ablation) through the end of the study or early discontinuation. 
o Serious adverse events (SAEs) will be captured from the time of subject consent 
through the end of the study or early discontinuation regardless of relationship to 
the study device or procedure. 
4.3 Secondary Endpoints 
• Technical Success: All A0 and A1 ablation classification determinations (complete tumor 
ablation with a surrounding minimal margin) as assessed by cone beam CT imaging, 
immediately following the ablation procedure. 
• Navigational Success: Successful navigation to the targeted peripheral lung tumor(s) as 
confirmed using cone beam CT (CBCT). 
• Local Tumor Progression (LTP): Recurrence of originally ablated target tumor(s) within or 
abutting the ablation zone using 30-day post-ablation imaging as the baseline. Measuring 
progression details will be outlined in a separate Imaging Charter. 
• Local Tumor Progression Free Survival (LTPFS): Time from the ablation until local 
tumor(s) progression (LTP) or death, whichever occurs first. Measuring progression 
details will be outlined in a separate Imaging Charter. 

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• Progression Free Survival: Time from the original ablation until tumor(s) progression or 
death, whichever occurs first (includes local, regional, or distant progression). Measuring 
progression details will be outlined in a separate Imaging Charter. 
• Disease (cancer) Specific Survival: Time from the original ablation until death from the 
treated primary malignancy. 
• Overall Survival: Time from the original ablation until subject death (includes death from 
any cause). 
• Repeat Ablation Efficacy Rate: Rate of original tumors that have been re-ablated 
successfully (i.e., Technical Success of tumors that have been re-ablated/all original 
tumors that have been re-ablated). 
• Change in all available PFTs (pulmonary function tests) from pre-ablation baseline values 
to values at 3 months, 6 months, and 12 months post-ablation. 
• Change in overall health-related quality of life (HRQOL) and sub-scales, including physical 
functioning and pain domains, per the validated EORTC QLQ-C30 and QLQ-LC13 
questionnaires throughout the duration of the study. 
4.4 Exploratory Endpoints 
• Level of Procedure Related Pain: Subject reported outcome determined by the Numeric 
Pain Scale. 
• Subject functionality as measured by distribution of Eastern Cooperative Oncology Group 
(ECOG) classification scores over time. 
• Hospital Readmission Rate: Any unplanned admission or re-admission to the hospital 
within 30 days of the ablation procedure due to an adverse event. 
• Procedural cost (UB-04), applicable for US sites only. 
• Number of systemic chemotherapy-free days from time of ablation through the duration of 
the study. 
4.5 Central Review Committee 
A central review committee of radiologists will independently review all CT scans (and other 
scans, as applicable) taken throughout the clinical study in an effort to standardize scan 
assessment and to minimize potential bias of the treating physician. Both the clinical site’s 
radiographic assessment and the central review committee’s assessment will be captured 
within the CRFs and reported within the final Clinical Study Report. The central review 
assessment for the following key endpoints will be used for the final analysis. The central 
review committee will analyze uploaded subject images from the site to assess the following 
key endpoints and data: 

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o Time, power, and maximum temperature 
o Procedure Time (including ablation): The time the robotic bronchoscope is inserted 
into the oropharynx until the time the robotic bronchoscope is removed. 
• Probe details (type of probe, number used, number of repositions) 
• Imaging details (number of 3D acquisitions performed and estimated radiation exposure) 

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5.0 
INVESTIGATIONAL PLAN 
5.1 Overall Study Design and Plan – Description 
This is a prospective, multicenter, single-arm study focused on robotically-assisted 
transbronchial microwave ablation for adult subjects with oligometastatic tumors in the lung. 
Principal Investigators across approximately 15 sites (United States, Canada, Hong Kong, and 
China) will be licensed pulmonologists/interventional pulmonologists or thoracic surgeons who 
have completed at least 20 diagnostic cases using the MONARCH Platform including at least 
5 cases using CBCT and completed the Sponsor-required FLEX MC training. 
Prospective subjects will be informed about the nature of the research, given the ICF to read, 
and if the subject understands the content, will be asked to provide consent by signing the ICF. 
Individuals scheduled for microwave ablation of the lung will be enrolled after providing 
informed consent and meeting study entry criteria. Subjects will be followed for 12 months 
following the first ablation procedure for safety and effectiveness outcomes. Enrollment will 
continue until up to 145 subjects are enrolled and treated. The Sponsor may also stop or pause 
enrolling new subjects prior to reaching 145 subjects based on either safety events, regulatory 
feedback, or inability to enroll appropriate subjects. 
Subjects with oligometastatic tumors(s) in the lung who meet all inclusion/exclusion criteria will 
have transbronchial microwave ablation performed using cone beam CT (computed 
tomography) scan for probe guidance and confirmation. 
The study will end when all enrolled and treated subjects have completed the 12-month, post- 
ablation follow-up period or have withdrawn consent prior to completion. 
5.2 Enrollment 
Up to 145 subjects will be enrolled and ablated in this clinical study. A subject is considered to 
be enrolled when the ICF is signed. Enrollment will continue until up to 145 subjects have been 
enrolled and had the ablation procedure is initiated. Participants who have the navigation 
initiated but do not receive the microwave ablation will either have the ablation rescheduled, 
pending cause, or will be considered an intra-operative withdraw/screen fail and will not count 
toward the 145 subjects enrolled and ablated. 
If a subject experiences an adverse event (AE) after navigation and does not receive the 
microwave ablation, the subject should be followed from a safety perspective until the AE 
resolves or is deemed stable. 
5.3 Inclusion Criteria 
Subjects satisfying the following criteria will be eligible to participate in this study: 
1. 
Signed informed consent. 
2. 
Subjects > 22 years old. 
3. 
Performance status 0-2 (Eastern Cooperative Oncology Group classification [ECOG]). 
4. 
Willing to fulfill all follow-up visit requirements. 

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5. 
Subjects with no more than five oligometastatic tumors in no more than three organ 
sites with no more than three tumors in any single organ. 
6. 
Presence of at least one oligometastatic lung tumor with colorectal, renal, or sarcoma 
histology where the primary tumor is controlled (in the opinion of the investigator or 
treating oncologist). Histology should be documented by the following criteria: 1) biopsy 
of target lesion, if feasible, or 2) imaging highly suspicious for metastatic lesion in 
context of a previous biopsy of the primary or other metastases. 
7. 
Oligometastatic lung tumor(s) planned to be ablated should be < 2cm (based on the 
Screening Visit image), in the outer two-thirds of the lung, and not closer than 1cm to 
the pleura (including fissures) or contiguous with the pleura. The outer two-thirds is 
defined as beyond the segmental airway, such that proximal endobronchial soft tissue 
tumors are avoided. 
Note 1: A maximum of two ipsilateral oligometastatic tumors may be ablated during a single 
session as part of this protocol. The tumor size measurement will be based on the Screening 
Visit image and does not need to be re-confirmed on the Ablation Day. 
Note 2: A maximum of three total oligometastatic lung tumors may be ablated as part of the 
protocol during the entire study follow-up period. 
Note 3: A second or third oligometastatic lung tumor may only be ablated if its planned ablation 
zone does not overlap with the ablation zone of the previously ablated tumor(s). 
5.4 Exclusion Criteria 
Subjects who meet any of the following criteria will not be eligible to participate in this study: 
1. 
Pregnant or breastfeeding. 
2. 
Subjects with thoracic implantable devices, including pacemakers or other electronic 
implants. 
3. 
Chronic, continuous ventilator support, which uses bi-level positive airway pressure 
(PAP) to improve lung function for severe conditions. (However, intermittent PAP, for 
non-pulmonary conditions, such as sleep apnea, is permitted). 
4. 
Prior pneumonectomy. 
5. 
Severe bronchiectasis (with FEV1 <30%) or disease deemed to be too severe in the 
opinion of the investigator. 
6. 
Clinical or imaging findings consistent with an active pulmonary infection. 
7. 
Platelet count ≤ 50,000/mm3. 
8. 
Subjects with uncorrectable coagulopathy at time of screening. 
9. 
Subjects medically unable to stop anti-platelet agents (e.g., aspirin, clopidogrel, 
prasugrel, ticagrelor) at least 5 days prior to the procedure through 48-72 hours after 
the procedure. 
10. 
Subjects medically unable to stop warfarin at least 3-5 days prior to the ablation 
procedure, or until INR < 1.5, through 48-72 hours after the procedure. On the day of 
the procedure, subjects with an INR > 1.5 cannot have the procedure completed that 
day but may be rescheduled or postponed. 

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11. Subjects medically unable to stop anticoagulants (e.g., rivaroxaban, apixaban, 
dabigatran, endoxaban) at least 3 days prior to the ablation procedure through 48-72 
hours after the procedure. 
12. Subjects who require heparin or low molecular weight heparin bridging. 
13. 
Expected survival less than 6 months in the opinion of the investigator and/or treating 
oncologist. 
14. 
Subjects with known or suspected brain metastases. 
15. 
Subject has had any radiation (i.e., SBRT or EBRT) to the intended ablation zone. 
16. 
Endobronchial tumors proximal to and including the segmental airways. 
17. Tumors where the anticipated zone of ablation would encompass significant (in the 
opinion of the treating physician) emphysematous or bullous disease. 
18. Subject who underwent lung ablation, surgical resection therapy, radiotherapy, or any 
other treating procedure within 30 days prior to the planned study ablation procedure 
or those who plan to receive a lung ablation, surgical resection, or radiation therapy on 
the ablated lung side before completing the primary endpoint assessment (30 days 
post-ablation). 
19. Subject who received systemic therapy (e.g., chemotherapy, targeted drug therapy, or 
immunotherapy) within 14 days prior to the planned study ablation procedure or those 
who plan to receive systemic therapy before completing the primary endpoint 
assessment (30 days post-ablation). 
20. Uncontrolled hypertension pre-procedure (Visit 2). Defined as systolic blood pressure 
≥ 160mmHg and/or diastolic blood pressure ≥ 100mmHg despite pharmacotherapy. 
21. 
Subjects who have participated in an investigational drug or device research study 
within 30 days of enrollment that would interfere with the primary endpoint of this study. 
22. 
Physical or psychological condition that would impair study participation. 
23. 
Severe neuromuscular disease. 
24. 
Subjects judged unsuitable for study participation by the Investigator for any other 
reason. 
Intra-operative exclusion criteria that lead to stopping a procedure: 
25. 
Inability to tolerate anesthesia. 
26. 
Time of navigation to initiation of ablation longer than 60 minutes, per target tumor. 
27. Bleeding estimated to exceed 50cc (visualization via the drainage system) or a 
Nashville grade 2 or higher intervention is required (see Appendix 2). 
28. If the CBCT imaging after a bleeding episode obscures the radiographic visibility of the 
tumor such that the ablation probe/tumor relationship is not discernable, the procedure 
should be terminated. 
29. Any presenting condition discovered intra-procedurally that in the opinion of the 
Investigator would make participating in this study not in the subject’s best interest. 
Note 1: For Exclusion Criterium 26, the procedure may be attempted again at a later time 
providing there were no other complications other than an extended navigation time. 
Note 2: For Exclusion Criteria 27 and 28, the procedure may be attempted again at a later 
time, once, in the opinion of the physician, the area of bleeding is fully resolved. 
Note 3: For any rescheduled ablations, the ablation should be rescheduled as soon as feasible 

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5.6 Screen Failures 
All subjects signing consent who do not meet all inclusion and exclusion criteria, or who do not 
have the procedure initiated (i.e., start of navigation to the target tumor(s)), will be recorded as 
screen failures. The relevant eCRF pages (Demographics, Inclusion/Exclusion Criteria, AEs, 
Subject Completion/Discontinuation, etc.) will be completed for all screen failure subjects. 
Participants who have the navigation initiated but do not receive the microwave ablation will 
either have the ablation rescheduled, pending cause, or will be considered an intra-operative 
withdraw/screen fail and will not count toward the 145 subjects enrolled and ablated. 
5.7 Removal of Subjects from the Study 
In accordance with the current revision of the Declaration of Helsinki and the Code of Federal 
Regulations, a subject has the right to withdraw from the study at any time for any reason 
without prejudice to his/her future medical care by the physician or the institution. Should a 
subject (or subject’s legally authorized guardian/representative) decide to withdraw from the 
study, all efforts will be made to collect any device- or procedure-related AEs or SAEs they may 
have experienced. 
Participation may be terminated prior to completing the study for any of the reasons listed below 
(reasons that do not fit the categories below will be documented as “other”). 
Withdrawal of Consent: 
If 
a 
subject 
chooses 
to 
withdraw 
early 
from 
the 
study, 
the 
eCRF 
Subject 
Completion/Discontinuation page should be completed. When a subject’s participation is 
terminated prior to completing the study, the reason for withdrawal is to be documented on the 
eCRF and in the source documentation. 
Investigator Termination: 
The Investigator has the right to terminate participation in the study at any time (e.g., for safety 
or inability to enroll subjects). Should termination of a site be necessary, the Sponsor will 
provide procedures for termination. 
Death: 
In the case of subject death, all efforts should be made to get the records documenting the 
cause of death including postmortem records. 
Lost to Follow-Up: 
All subjects should be encouraged to return for protocol required clinic visits for evaluation 
during the study follow-up period. If a subject is unable to return for a clinic visit or unable to be 
contacted by telephone, attempts to contact the subject should be documented in the source 
documents. Only after failing to contact the subject at the final follow-up visit, the subject will 
be considered lost to follow-up and the primary reason for early termination will be completed 
in the eCRF. 
Site Termination or Study Termination: 

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The Sponsor may terminate a site or the study at any time. When this occurs all subjects at the 
site will be withdrawn and documented as “early termination.” Reasons for site or study 
termination may include, but are not limited, to the following: 
• 
Administrative concerns (e.g., inadequate subject enrollment, investigator/institution non- 
compliance, change of business strategy, etc.). 
• 
Safety issues, including those due to non-compliance, which substantially affect the risk- 
to-benefit ratio of the study subjects at a site or for the study as a whole. 
• 
Regulatory body mandate(s). 

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6.0 
STUDY PROCEDURES 
6.1 Procedure Description(s) 
Adult subjects with at least one oligometastatic tumor (< 2cm) in the lung located in the outer 
two-thirds and not closer than 1cm to the pleura (including fissures) with colorectal, renal, or 
sarcoma histology will have transbronchial microwave ablation performed using the 
MONARCH Platform. 
 
Multidisciplinary Team 
With regard to the clinical treatment approach for each patient, this is best assessed and 
determined by a local (i.e., site) multidisciplinary team (MDT) (aka tumor board) directly caring 
for the subject. An MDT discussion will be required prior to subject ablation to determine or 
ensure 1) that all oligometastatic tumors present at Screening are deemed treatable, 2) the 
manner/timing that all disease sites will be treated, and 3) the appropriateness of subject 
inclusion in the study. The MDT will include, at a minimum, a medical oncologist, thoracic 
surgeon or appropriate surgical specialist, and radiation oncologist. 
Screening and Planning 
A CT scan of the lung is used at Screening to determine tumor details (e.g., size, location, and 
type, if available). Tumor size must be measured in 3 axes (axial, sagittal, and coronal). 
A maximum of two ipsilateral tumors that meet all inclusion and exclusion criteria may be 
ablated during a single session as part of this protocol. The second tumor may only be ablated 
if its planned ablation zone does not overlap with the ablation zone of the previously ablated 
tumor. 
If a subject had three oligometastatic tumors that met all inclusion and exclusion criteria, but 
only two could be treated, per protocol, on the “Ablation Visit”, the third, non-target tumor may 
be ablated at a later study visit. Similarly, if a new, non-target oligometastatic tumor is identified 
during study follow-up that meets all inclusion and exclusion criteria, it may be ablated. 
However, only up to three total oligometastatic lung tumors (“target” or “non-target”) may be 
ablated as part of this protocol during the 12-month follow-up period. 
If target tumors recur after the original ablation, they may be re-ablated after the Visit 3 
assessment for Technique Efficacy has been completed. A re-ablation will not change or 
extend the follow-up schedule. Additionally, no single tumor should be ablated more than twice 
during the 12-month follow-up period (i.e., the original ablation procedure and a re-ablation 
procedure at a separate visit). Robotic Navigation Portion of Procedure 
Cone beam CT will be used in all cases to confirm the presence of the tumor(s) immediately 
before initiating the procedure. Navigation to the target tumor(s) will be performed using the 
MONARCH Platform. The MONARCH Platform is a novel robotic-assisted, software driven, 
endoscope articulation system which can electromechanically insert, steer, and withdraw a 
flexible endoscope to patient airways under continuous, real-time, direct, visual control by a 
physician operator. 

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Users must follow all instructions for use supplied with the MONARCH Platform, its 
components, instruments, and accessories, including any instructions for use (IFUs) provided 
with instruments or accessories. The provided IFU is the primary source for detailed safety 
information. The MONARCH Platform and its accessories are intended to provide 
bronchoscopic visualization of and access to patient airways for diagnostic and therapeutic 
procedures. 
Microwave Ablation Portion of Procedure 
The ablation will be performed using the NEUWAVE FLEX MC Microwave Ablation System, 
per the device’s User Manual and Instructions for Use (IFU), and the performing physician’s 
clinical judgment. 
All ablations will be performed under general anesthesia via a transbronchial approach. 
Prophylactic antibiotics should be administered pre-ablation per site SOC. 
The size of the tumor(s) will be measured and recorded on the day of ablation (Visit 2). 
Afterwards, the Monarch Platform will be used to navigate the microwave ablation probe to the 
target tumor and CBCT will be used to confirm probe position/placement. 
If the treating physician believes that bleeding during the navigation or ablation requires 
intervention, or if the bleeding obscures the view of the tumor or ablation zone, the physician 
is advised to terminate the procedure. The procedure may be attempted again at a later time, 
once, in the opinion of the physician, the area of bleeding is fully healed. The ablation should 
be rescheduled within four weeks of the originally scheduled ablation. Other than INR, other 
pre-ablation assessments do not need to be repeated. 
If the target tumor(s) is within approximately 5mm of a major vessel (in the opinion of the 
treating physician), this tumor should not ablated, or navigated to, for risk of puncture during 
the navigation. Additionally, tumors where the anticipated zone of ablation would encompass 
a significant (in the opinion of the treating physician) emphysematous disease and should also 
be avoided. 
CBCT will be used to guide the microwave ablation probe to the target tumor(s) and ascertain 
the location of the probe after the robotic bronchoscope has been retracted. CBCT scans will 
be used at a minimum of three timepoints pre- and post- the ablation process: 
(1) Pre-Navigation: Prior to starting navigation, CBCT will be used to establish baseline 
imaging, confirm tumor details, and tumor segmentation for navigation (i.e., augmented 
fluoroscopy). 
(2) Pre-Ablation: Immediately before the ablation, use CBCT to confirm that the probe is in 
the intended location, and if it is not, reposition the probe. 
(3)  Post-Ablation: After completing the ablation, use CBCT to confirm that the ablation 
margins are adequate. 
The smallest and largest length of the entire ablation zone as well as the smallest ablation 
margin (i.e., distance from the edge of the ablation zone to the edge of the target tumor), must 
be measured in 3-dimensions and captured in the clinical database. 

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If a PET scan is taken during the follow-up period, the site must also perform the diagnostic CT 
as per protocol. PET scans, if obtained, should also be uploaded to the study imaging database 
with the other required images. 
After the ablation procedure, the subject will be observed for up to 23 hours before discharge, 
except in cases where the Investigator deems it is necessary for the subject to remain 
hospitalized. 
For specific details regarding the microwave ablation procedure and workflow between 
MONARCH and FLEX, please refer to the User Manual. 
Tumor Ablation Classification 
Ablation classification used for the determination of Technical Success at the time of the final 
post-procedure scan for a target tumor will be determined using 3-dimensional (3D) 
assessment (coronal, sagittal, and axial) and defined as: 
• A0 = Complete tumor ablation with an ideal minimal margin (i.e., a surrounding minimal 
margin of at least 5mm). 
• A1 = Complete tumor ablation with a minimal margin (i.e., a surrounding minimal margin 
of less than 5mm but more than 0mm). 
• A2 = Incomplete tumor ablation. 
While Technical Success will be defined as either an A0 or A1 ablation, the goal is to achieve 
A0 ablation, and this will be a pre-specified secondary analysis. For all A1 and A2 ablation 
classifications, the PI will document the reason(s) why a margin of at least 5mm was not 
attainable on the applicable eCRF. 
 

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6.2 System Overview 
The NEUWAVE FLEX MC Microwave Ablation System is a fully featured soft tissue ablation 
system that uses small diameter flexible ablation probes, a single high-powered, gas cooled 
microwave source operating at 2.45 GHz, a CO2-based cooling system, and a Power 
Distribution Module (PDM). Microwave energy is applied to the target tissue via a single flexible 
ablation probe, heating the tissue to the point of necrosis. The FLEX System received 510(k) 
clearance as a Class II device (K163118) for ablation (coagulation) of soft-tissue. 
The FLEX MC Microwave Ablation System is designed to be used in target ablation. Target 
ablation involves placing a probe into a substantial target and then ablating for up to several 
minutes until the target tissue is necrotic. 
The FLEX probes are designed for improved navigation. They are French gauge 6 (outer 
diameter of less than 2mm) and 150cm long. The FLEX probes contain three temperature 
measurement sensors that help monitor performance and ensure subject and operator safety. 
The FLEX probe antenna was designed to produce an ablation zone substantially equivalent 
to the predicate NEUWAVETM PR probe, but within a flexible probe shaft. Like the predicate 
PR probe, the FLEX probes were designed to produce ablations that encompass the tip of the 
probe while limiting the overall length of the ablation. Testing in ex-vivo liver, lung, and kidney 
tissue confirmed that the FLEX probes produce ablations that are substantially equivalent to 
the predicate probes. 
A CO2 based cooling system ensures the non-active portion of the probe does not exceed 
temperature requirements. The system uses two customer-supplied CO2 cylinders. The system 
monitors the pressure of the tanks and heats the tanks to maintain the desired tank pressure. 
The FLEX System will select which cylinder to initially use based upon tank pressures. 
The MONARCH Platform enables electro-mechanical articulation and precise control of a 
flexible bronchoscope under continuous and direct control by a physician operator. The 
MONARCH Bronchoscope is the subject interfacing component of the MONARCH Platform. 
Additional components of the platform are the MONARCH Cart and the MONARCH Tower. 
The Platform received 510(k) clearance as a Class II device (K211493) for diagnostics and 
therapeutics. The system has several components that interface to the Tower and Cart 
including: The Fluidics tubing, MONARCH Control, Electro-Magnetic Field generator, and 
Reference Electro-Magnetic sensors. 
The flexible MONARCH bronchoscope has a working channel and a camera at the tip. The 
camera provides the operative perspective, an integrated light at the scope tip, and a 2.1mm 
inner diameter working channel for the passing of tools. The bronchoscope’s working channel 
is used for irrigation, aspiration, and access for working channel instruments. The single- 
use bronchoscope is cleared via K193534, and the equivalent re-processed single-use 
bronchoscope is cleared via K203614. 
The MONARCH Bronchoscope is a comprised of two collinear and concentric devices, the 
inner scope, and the outer sheath, both of which possess 4-way steering control. This 
configuration enables the capability of telescoping, which enhances the bronchoscope stability 
and access capability. 

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The inner scope and outer sheath have a distal section capable of achieving articulation in 
pitch, yaw, and any combination of the two to enable precise control while driving the 
bronchoscope. Proximally, the inner scope is equipped with a valve to facilitate the insertion 
and sealing of various ancillary devices, such as a biopsy needle or FLEX probes. Additionally, 
the proximal section routes irrigation and aspiration to the working channel. 
6.3 Identity of Study Products 
For this study, medical devices will be used in accordance with manufacturer design 
specifications, product instructions, and guidelines. All study medical devices are described, 
below: 
• NEUWAVE FLEX MC Microwave Ablation System and Accessories 
Sub-products of the above device are listed, below: 
• NEUWAVE FLEX Microwave Ablation System and Accessories 
o FLEX Microwave Ablation System 
o FLEX Microwave Ablation Probes 
• Auris MONARCH Platform 
o Cart 
o Tower 
o Bronchoscope 
6.4 Study Product Accountability 
The NEUWAVE FLEX MC Microwave Ablation System and Accessories must be stored in 
conditions according to its labeling and IFU. It is the responsibility of the Principal Investigator 
(PI) to ensure that devices are stored correctly at their respective site. 
The PI, or responsible person designated by the PI, must account for all study devices 
throughout and, at the end of, the clinical study. During the course of the study, the study’s 
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. The PI must 
allow the Study Monitor access to the secured facility where the study devices are stored to 
check inventory. 
The Sponsor may supply the Auris MONARCH Platform (including accessories), the 
NEUWAVE FLEX Microwave Ablation System, and the microwave ablation probes to the study 
sites. Upon receipt, the Investigator, or delegated staff, will complete the following: 
• Conduct an inventory. 
• Upon confirmation that all materials arrived intact, complete the Study Article 
Accountability Log. 
• Retain a copy of the signed and dated Packing List for Clinical Supplies for the 
Investigator’s records. 

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The study device inventory must be available for periodic inspection/verification by relevant 
Sponsor representatives, including monitors, auditors, site inspectors (routine or for-cause), 
any regulatory health authority, or IRB/EC. 

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7.0 
STUDY VISIT SCHEDULE 
The Schedule of Assessments may be found in Table 1 at the end of the Protocol Summary. 
7.1 Visit 1 – Screening 
The screening assessments may occur over several dates within 30 days prior to Visit 2 
(Ablation Day), but screening assessments should not be conducted on Visit 2 (Ablation Day). 
Subjects will be selected for microwave ablation based on the pre-procedure assessments and 
the Investigator’s interpretation of the clinical picture. Eligible subjects will be provided with the 
study information, including the ICF. 
The following screening assessments will occur prior to the study procedure: 
• Subjects must be given ample time to review, ask questions, and sign the ICF. 
• PI will review inclusion/exclusion criteria and determine if the subject is eligible to 
participate in the study. 
• Collect demographic information (age at time of Visit 1, sex, race, ethnicity). 
• Review and collect medical and surgical history, radiation history, and smoking status. 
• Record all relevant prior medications (taken within 30 days of Visit 2), including but not 
limited to blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, 
systemic steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and 
medications used to treat adverse events 
• Record all concomitant procedures. 
• Collect height and body weight for BMI. 
• Collect key vitals: blood pressure, heart rate, and pulse oximetry. 
• Evaluate ECOG performance status. 
• Obtain PFTs, which include Spirometry (e.g., FEV1, FVC, FEV1/FVC, FEF25-75, Peak 
Expiratory Flow, and Maximum Ventilation Volume), Diffusion Capacity (DLCO), Total 
Lung Capacity (TLC), Functional Residual Capacity (FRC), and Residual Volume (RV). 
• Laboratory tests. If these tests (based on SOC) were completed within 30 days of Visit 2, 
they do not need to be repeated at the Screening visit: 
o CBC with differentials. 
o Coagulation tests, including APTT and PT per site’s SOC. INR is required. 
o Only for women of childbearing potential, complete a pregnancy test per site SOC 
(urine or serum). 
o Data for any serum-based tumor markers (e.g., CEA and LDH) or molecular profiling 
on the tumor tissue will be collected, if done as part of site SOC. 
• Complete the Numeric Pain Rating Scale. 
• Complete two validated quality of life questionnaires: EORTC QLQ-C30 and the lung- 
specific QLQ-LC13. These questionnaires should be administered in person, during the 
study visit. However, they may be administered over the phone, when needed. 
• Chest CT to determine tumor details (e.g., size and location). Tumor size must be 
measured in 3 axes (axial, sagittal, and coronal). Note: Contrast-enhanced imaging is 

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preferred, but not required. 
• Abdomen and pelvis CT. Note: If the subject had an abdomen and pelvis CT taken within 
90 days of the visit, it does not need to be repeated during this visit. Contrast-enhanced 
imaging is preferred, but not required. 
• Brain MRI (with or without contrast), per site SOC. Note: A brain MRI image may be 
included as part of Screening if it was completed within 12 months of the visit. 
• Extremity CT or MRI (with or without contrast), per site SOC. Note: An extremity CT or 
MRI image may be included as part of Screening if it was completed within 90 days of the 
visit. 
• Record any adverse events (AEs) or serious adverse events (SAEs) that may have 
occurred after the signing of the ICF. 
7.2 Visit 2 – Ablation Procedure Through Discharge 
Visit 2: Pre-Procedure 
INR should be one of the first assessments completed on the ablation day to ensure it is < 1.5 
or the ablation should be rescheduled. Other assessments, if completed, do not need to be 
repeated as long as the ablation is completed within two weeks of the originally scheduled 
ablation. 
• PI will review inclusion/exclusion criteria and determine if the subject continues to be 
eligible to participate in the study. 
• Document any changes or updates to the subject’s relevant concomitant medications 
(blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, systemic 
steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and medications 
used to treat adverse events) 
• Document any changes or updates to the subject’s concomitant procedures. 
• Collect key vitals: blood pressure, heart rate, and pulse oximetry. 
• Evaluate ECOG performance status. 
• Laboratory tests: 
o Coagulation tests, including APTT and PT per site’s SOC. INR is required. 
o Only for women of childbearing potential, complete a pregnancy test per site SOC 
(urine or serum). 
• Complete the Numeric Pain Rating Scale. 
• Record any AEs or SAEs that may have occurred since the last visit. 

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Visit 2: Intra-Procedure 
The Sponsor will provide access to a Product Development Specialist and/or a Medical 
Specialist experienced in this procedure for the treating physician as needed. Please refer to 
the User Manual for additional details. 
• CBCT to guide the microwave ablation probe to the target tumor(s) and ascertain the 
location of the probe after the robotic bronchoscope has been retracted. CBCT scans will 
be used at a minimum of three timepoints pre- and post- the ablation process: 
(1) Pre-Navigation: Prior to starting navigation, CBCT will be used to confirm general 
tumor details and tumor segmentation for navigation (i.e., augmented fluoroscopy). 
(2) Pre-Ablation: Immediately before the ablation, use CBCT to confirm that the probe 
is in the intended location, and if it is not, reposition the probe. 
(3) Post-Ablation: After completing the ablation, use CBCT to confirm that the ablation 
margins are adequate. 
• Perform the microwave ablation procedure: Perform an initial ablation for a maximum of 
5 minutes, then after waiting for approximately 10 minutes, perform a CBCT scan to 
ascertain appropriate progression of the size of the ablation zone. This allows for 
assessment of the ablation zone to determine whether a sufficient margin has been 
achieved. 
o If adequate minimal margin was not achieved, additional ablations may be performed. 
o If probe repositioning is required, additional CBCT confirmation is required to ensure 
the probe is in the intended location. 
o Additional ablations should be no more than 5 minutes per ablation. 
o CBCT imaging must be completed after any additional ablation. 
• Record ablation procedure details, including but not limited to: 
o Date and time of the ablation procedure. 
o Anatomical location of ablations. 
o Number of ablation cycles, power, and time used for each ablation. 
o Number of CBCT scans performed for probe placement and margin assessment. 
o Total radiation exposure from the procedure. 
o Number of probes used, type of probes, and probe placement attempts per ablation. 
o Duration of procedure, measured as the time when the bronchoscope enters the 
endotracheal tube to the time when the last CBCT scan is taken. 
• Evaluate Technical Success, defined as all A0 and A1 ablation classification 
determinations (complete tumor ablation with a surrounding minimal margin) as assessed 
by CBCT imaging, immediately following the ablation procedure. 
• Record any AEs or SAEs that may have occurred during the procedure. 

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Visit 2: Post-Procedure – Discharge 
• Document any changes or updates to the subject’s relevant concomitant medications 
(blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, systemic 
steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and medications 
used to treat adverse events). 
• Document any changes or updates to the subject’s concomitant procedures. 
• Complete the Numeric Pain Rating Scale. 
• Collect key vitals: blood pressure, heart rate, and pulse oximetry. 
• Collect UB-04 data on procedural cost. 
• LOS, measured from post-ablation to discharge. Note: after the ablation procedure, the 
subject will be observed for up to 23 hours before discharge, except in cases where the 
Investigator deems it is necessary for the subject to remain hospitalized. 
• Record any AEs or SAEs that may have occurred after the procedure until the subject is 
discharged. 
 
7.3 Visit 3 – 30-day Follow-up 
Visit 3 occurs 30 days (-7 to +14 days) after the ablation procedure. The subject will visit the 
study site for the following assessments: 
• Document any changes or updates to the subject’s relevant concomitant medications 
(blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, systemic 
steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and medications 
used to treat adverse events) 
• Document any changes or updates to the subject’s concomitant procedures. 
• Complete two validated quality of life questionnaires: EORTC QLQ-C30 and the lung- 
specific QLQ-LC13. These questionnaires should be administered in person, during the 
study visit. However, they may be administered over the phone, when needed. 
• Collect key vitals: blood pressure, heart rate, and pulse oximetry. 
• Evaluate ECOG performance status. 
• Evaluate Technique Efficacy, defined as ablation of the target tumor(s) with the ablation 
zone completely overlapping or encompassing the entire target tumor(s) using CT 
imaging at 30 days (-7 to +14 days) post the original ablation procedure. 
• Record readmission to any hospital for any unplanned reason within 30 days of the 
ablation. The Investigator will assess the reason for the admission and capture the reason 
in the clinical database. 
• Record any applicable AEs or SAEs: 
o If within 30 days of the ablation procedure, record any AEs or SAEs that may have 
occurred since the last study visit. 
o If after 30 days of the ablation procedure, record only device- or procedure-related 
AEs or any SAEs that may have occurred since the last study visit. 

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7.4 Visit 4 – 3-month Follow-up 
Visit 4 occurs 3 months (± 2 weeks) after the ablation procedure. The subject will visit the study 
site for the following assessments: 
• Document any changes or updates to the subject’s relevant concomitant medications 
(blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, systemic 
steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and medications 
used to treat adverse events) 
• Document any changes or updates to the subject’s concomitant procedures. 
• Complete two validated quality of life questionnaires: EORTC QLQ-C30 and the lung- 
specific QLQ-LC13. These questionnaires should be administered in person, during the 
study visit. However, they may be administered over the phone, when needed. 
• Collect key vitals: blood pressure, heart rate, and pulse oximetry. 
• Evaluate ECOG performance status. 
• Obtain PFTs, which include Spirometry (e.g., FEV1, FVC, FEV1/FVC, FEF25-75, Peak 
Expiratory Flow, and Maximum Ventilation Volume), Diffusion Capacity (DLCO), Total 
Lung Capacity (TLC), Functional Residual Capacity (FRC), and Residual Volume (RV). 
• Complete chest CT, abdomen and pelvis CT, brain MRI (if site SOC), and extremity CT 
or MRI (if site SOC) to determine Tumor Progression. Contrast-enhanced images are 
preferred but not required. If a site takes a PET scan per SOC, the other images should 
also be taken, per protocol: 
o Local Tumor Progression (LTP), defined as recurrence of the originally ablated 
tumor(s) within or abutting the ablation zone using Chest CT and the 30-day post- 
ablation imaging as the baseline. 
o Regional Tumor Progression includes new or progression of pre-existing tumors that 
were not previously ablated within either lung using chest CT. 
o Distant Tumor Progression includes new or progression of pre-existing tumors outside 
of the lung using abdomen and pelvis CT, brain MRI, and extremity CT or MRI. 
• Record any applicable AEs or SAEs: 
o Record any AEs or SAEs that may have occurred within 30 days of an ablation or re- 
ablation procedure. 
o Record only device- or procedure-related AEs or any SAEs that may have occurred 
after 30 days of an ablation or re-ablation procedure. 
7.5 Visit 5 – 6-month Follow-up 
Visit 5 occurs 6 months (± 1 month) after the ablation procedure. The subject will visit the study 
site for the following assessments: 
• Document any changes or updates to the subject’s relevant concomitant medications 
(blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, systemic 

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steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and medications 
used to treat adverse events) 
• Document any changes or updates to the subject’s concomitant procedures. 
• Complete two validated quality of life questionnaires: EORTC QLQ-C30 and the lung- 
specific QLQ-LC13. These questionnaires should be administered in person, during the 
study visit. However, they may be administered over the phone, when needed. 
• Collect key vitals: blood pressure, heart rate, and pulse oximetry. 
• Evaluate ECOG performance status. 
• Obtain PFTs, which include Spirometry (e.g., FEV1, FVC, FEV1/FVC, FEF25-75, Peak 
Expiratory Flow, and Maximum Ventilation Volume), Diffusion Capacity (DLCO), Total 
Lung Capacity (TLC), Functional Residual Capacity (FRC), and Residual Volume (RV). 
• Complete chest CT, abdomen and pelvis CT, brain MRI (if site SOC), and extremity CT 
or MRI (if site SOC) to determine Tumor Progression. Contrast-enhanced images are 
preferred but not required. If a site takes a PET scan per SOC, the other images should 
also be taken, per protocol: 
o Local Tumor Progression (LTP), defined as recurrence of the originally ablated 
tumor(s) within or abutting the ablation zone using Chest CT and the 30-day post- 
ablation imaging as the baseline. 
o Regional Tumor Progression includes new or progression of pre-existing tumors that 
were not previously ablated within either lung using chest CT. 
o Distant Tumor Progression includes new or progression of pre-existing tumors outside 
of the lung using abdomen and pelvis CT, brain MRI, and extremity CT or MRI. 
• Record any applicable AEs or SAEs: 
o Record any AEs or SAEs that may have occurred within 30 days of an ablation or re- 
ablation procedure. 
o Record only device- or procedure-related AEs or any SAEs that may have occurred 
after 30 days of an ablation or re-ablation procedure. 
7.6 Visit 6 – 12-month Follow-up 
Visit 6 occurs 12 months (± 1 month) after the first ablation procedure. The subject will visit the 
study site for the following assessments: 
• Document any changes or updates to the subject’s relevant concomitant medications 
(blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, systemic 
steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and medications 
used to treat adverse events) 
• Document any changes or updates to the subject’s concomitant procedures. 
• Complete two validated quality of life questionnaires: EORTC QLQ-C30 and the lung- 
specific QLQ-LC13. These questionnaires should be administered in person, during the 
study visit. However, they may be administered over the phone, when needed. 
• Collect key vitals: blood pressure, heart rate, and pulse oximetry. 
• Evaluate ECOG performance status. 

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• Obtain PFTs, which include Spirometry (e.g., FEV1, FVC, FEV1/FVC, FEF25-75, Peak 
Expiratory Flow, and Maximum Ventilation Volume), Diffusion Capacity (DLCO), Total 
Lung Capacity (TLC), Functional Residual Capacity (FRC), and Residual Volume (RV). 
• Complete chest CT, abdomen and pelvis CT, brain MRI (if site SOC), and extremity CT 
or MRI (if site SOC) to determine Tumor Progression. Contrast-enhanced images are 
preferred but not required. If a site takes a PET scan per SOC, the other images should 
also be taken, per protocol: 
o Local Tumor Progression (LTP), defined as recurrence of the originally ablated 
tumor(s) within or abutting the ablation zone using Chest CT and the 30-day post- 
ablation imaging as the baseline. 
o Regional Tumor Progression includes new or progression of pre-existing tumors that 
were not previously ablated within either lung using chest CT. 
o Distant Tumor Progression includes new or progression of pre-existing tumors outside 
of the lung using abdomen and pelvis CT, brain MRI, and extremity CT or MRI. 
• Record any applicable AEs or SAEs: 
o Record any AEs or SAEs that may have occurred within 30 days of an ablation or re- 
ablation procedure. 
o Record only device- or procedure-related AEs or any SAEs that may have occurred 
after 30 days of an ablation or re-ablation procedure. 
7.7 Unscheduled Visits 
The following data will be collected during each unscheduled visit: 
• Reason for the unscheduled visit. 
• Document any changes or updates to the subject’s relevant concomitant medications 
(blood thinning/anticoagulants, antiplatelets, opioids, systemic chemotherapy, systemic 
steroids, immunotherapies, anti-inflammatories, NSAIDs, antibiotics, and medications 
used to treat adverse events) 
• Document any changes or updates to the subject’s concomitant procedures. 
• Record any applicable AEs or SAEs: 
o Record any AEs or SAEs that may have occurred within 30 days of an ablation or re- 
ablation procedure. 
o Record only device- or procedure-related AEs or any SAEs that may have occurred 
after 30 days of an ablation or re-ablation procedure. 

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8.0 
DATA MANAGEMENT AND INTEGRITY 
8.1 Data Completion and Record Keeping 
Source Documents 
Source documents are documents on which information regarding subjects is first recorded, 
including printed, optical, or electronic documents. Investigator subject files or hospital records 
generally are the basis of source document information. This includes, but is not limited to, the 
following: original subject files; hospital/clinic records; original recordings/tracing; digital images 
from automated instruments (e.g., cameras); radiographs; device accountability records; 
photographic negatives; and, records kept at the investigation site, at the laboratories, and at 
other departments involved in the clinical investigation. Assessments made by the central 
review committee that are directly entered into the CRFs may also be considered as source 
documents. 
Other source data comes from NeuWave Medical’s Call Home Database. The NEUWAVE 
FLEX Ablation System has a functionality that electronically collects procedure data and 
information during the ablation procedure and is transmitted by the NEUWAVE Ablation System 
to NeuWave Medical, Inc., after the conclusion of each ablation procedure; this information is 
collectively called the “Call Home Database.” The procedure data include, but are not limited 
to, the following: date and time of procedure, anatomical location of ablations, number of 
ablation cycles and power used for each ablation, number of probe placement attempts per 
ablation, type of probes used, and type of anesthesia. Some of these relevant ablation 
procedure details will be provided to the site via a report generated from Call Home Database 
called a Call Home Report. The study site will review the report for accuracy and enter the 
procedure details into the study’s clinical database. Reports generated from the Call Home 
Database must be retained by the Investigator as part of the subject’s permanent medical 
record. The report should be retained for review and source data verification by the monitor. If 
a site is unable to receive the report generated from the Call Home Database, the relevant 
ablation procedure details should be manually recorded in the source documents from what is 
displayed on the NeuWave System monitor screen. 
All applicable scans (i.e., cone beam CT scans (taken during the ablation procedure), all 
conventional CT scans (taken during the post-ablation follow-up visits), and applicable PET 
scans should be de-identified and uploaded to the study imaging database in DICOM (digital 
imaging and communications in medicine) format, if possible. The imaging database will be 
controlled and maintained by the same vendor that organized and contracted the Central 
Review Committee, 
 
The Sponsor will have “read-only” access to the imaging database during the study. 
Separate instructions for the site to de-identify and upload all applicable scans will be provided 
in a separate document. 
Also, only for those subjects who specifically consent, some ablation procedures may be filmed 
for training and educational purposes. 
Source documents must be retained by the Investigator as part of the subject’s permanent 
medical record. The information in the source documents is used to complete the eCRFs. All 

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information captured on the eCRFs should be completely and accurately supported in source 
documentation. Any additional information relevant to the study should be included in the 
source documents. Particularly, any deviations from the protocol or procedures should be 
recorded in the source documents. The Investigator will retain originals of all source 
documents, subject consent forms, and study data. 
Electronic Data Capture 
An EDC system will be used by site personnel to transfer data from source records (medical 
records and/or source document worksheets) onto common eCRFs. This system is a web- 
based, secure electronic software application 
 
 
 
. This system was designed and is developed and 
maintained by 
 in a manner that is compliant with national and international GCP 
data protection/data privacy and electronic record/electronic signature (e.g., 21 CFR Part 11) 
regulatory requirements. The EDC system will be used to facilitate the collection of all data at 
the site. Designated site personnel will be responsible for entering subject data into the EDC 
system. All external and Sponsor internal users will be trained on the EDC application at a level 
dependent on their planned function. An EDC digital User Manual will be available under the 
help menu within the 
 website to assist in the collection and entry of source data 
into the electronic casebook. 
A 24/7/365 Help Desk Support line 
 
 staffed by the outsourced vendor will also be 
available to respond to site and monitor questions. 
Data Collection 
Each EDC eCRF will be completed by the PI or PI’s designee. Every effort should be made to 
respond to all monitoring and/or data management questions on each eCRF as completion of 
the data is required by the protocol. A unique ID number will identify each subject. The subject’s 
unique study ID number will be visible on each eCRF. At no time should the subject’s name 
appear on the eCRFs. 
All data should be recorded accurately and completely. The Investigator is responsible for 
reviewing and approving each completed eCRF. The Investigator will document assurance of 
overall review and approval by electronically signing each subject’s electronic casebook. 
Data Correction 
Required data corrections to eCRFs will be prompted via automated electronic edit checks 
and/or queries manually created by Sponsor reviewers. The change, the person making the 
change, and the time the change was made to the eCRFs will be automatically captured in the 
audit trail 
. 
Data Privacy 
The collection, use, and disclosure of all personal data, including subject health and medical 
information, are to be maintained in compliance with applicable personal data protection and 
security laws and regulations that govern protected health information and the informed 
consent given by each subject. When collecting and processing such personal data, 

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appropriate measures are to be taken to maintain the confidentiality of subject health and 
medical information and to prevent access by unauthorized persons. 
None of the data collected and transmitted by Call Home Database is attributable to an 
identifiable subject. 
Record Retention, Inspection, and Custody 
The Investigator must maintain all documentation related to the study until notified by the 
Sponsor. The Investigator will allow representatives of the Sponsor, the FDA, or other 
government regulatory agencies to inspect all study records, eCRFs, and corresponding 
portions of the subject’s office and/or hospital medical records at regular intervals during the 
study. These inspections are to verify adherence to the protocol, integrity of the data being 
captured on the eCRFs, and compliance with applicable regulations. 
Study reports will not identify subjects by name. These reports may be submitted to the FDA 
and/or regulatory authorities. 
If custody of the clinical study records is transferred, notice of such a transfer should be given 
to the Sponsor no later than 10 working days after the transfer occurs. 
8.2 Medical Dictionary Coding 
Medical dictionary coding of medical history and verbatim AEs captured on eCRFs will be 
performed using a coding thesaurus algorithm. The Medical Dictionary for Regulatory Activities 
(MedDRA) and WHODrug dictionaries will be used after data entry and query resolution, via 
auto-encoding and interactive coding processes. 
8.3 Data Quality Assurance 
Steps to be taken to assure the accuracy and reliability of data include the selection of qualified 
investigators and appropriate sites, review of protocol procedures with the Investigator and 
associated personnel prior to the study, and periodic monitoring visits by the Sponsor. The 
Sponsor will review eCRFs for accuracy and completeness during monitoring visits (onsite or 
offsite); any discrepancies will be resolved with the Investigator or designees, as appropriate. 
8.3.1 Investigator Training 
Prior to screening subjects for this study, the PI, sub-Investigators, study coordinators, and 
other designated staff (as applicable) will be provided information on study execution, data 
collection, and procedures specific to this clinical protocol. All training, and retraining, if 
necessary, will be documented accordingly and filed. 
8.3.2 Monitoring 
This study will be monitored by the Sponsor to ensure the following: 
• The rights and well-being of the subjects are protected. 
• The reported data is accurate, complete, and verifiable from source documents where 
utilized. 
• The conduct of the study is in compliance with the currently approved 
protocol/amendment(s), applicable GCPs, and with applicable local/regional regulatory 

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requirements. 
The extent and nature of monitoring will be predetermined and agreed to by the Sponsor and 
investigators. Monitors will comply with established written standard operating procedures as 
well as procedures specified by the Sponsor for monitoring this study as characterized in the 
Monitoring Plan. 

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9.0 
DEVIATIONS FROM THE PROTOCOL 
A protocol deviation is any noncompliance with the registry protocol, Good Clinical Practice, or 
protocol-specific requirements. A deviation (any activity conducted outside the parameters 
established by the protocol) can be identified from a number of sources. Potential sources include 
but are not limited to: a member of the Investigator’s staff, a Sponsor representative during 
monitoring visits, or a member of the data management or statistical groups when entering or 
analyzing data. Regardless of the source, it is crucial to document the deviation in the protocol 
deviation eCRF. The Investigator will report protocol deviations to the IRB/EC as required by the 
IRB/EC procedures. 
Any deviation from the protocol or procedures should be recorded in the source documents. 
Assessments or visits that are not completed because they are not SOC at a site should not be 
considered protocol deviations if the protocol specifies that the assessment or visit is only to be 
collected if SOC. 
Steps to be taken to assure the accuracy and reliability of data include the selection of qualified 
Investigators and appropriate sites, review of protocol procedures with the Investigator and 
associated personnel prior to the study, and periodic monitoring visits by the Sponsor. The Sponsor 
will review eCRFs for accuracy and completeness during monitoring visits; any discrepancies will 
be resolved with the Investigator or designees, as appropriate. All deviations to the protocol 
requirements should be documented in the source as well as the protocol deviation eCRF. 

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10.0 STATISTICAL METHODOLOGY 
10.1 Statistical and Analytical Plans 
The Sponsor Data Management and Biostatistics groups will be responsible for the analysis of 
data from this protocol. A comprehensive and detailed Statistical Analysis Plan (SAP) will be 
finalized prior to database lock to supplement the statistical design and analysis described in 
this section. 
Categorical variables will be summarized descriptively by frequencies and associated 
percentages. Continuous variables will be summarized descriptively by number of subjects, 
mean, standard deviation, median, minimum, and maximum. 
10.2 Study Design 
This is a prospective, multicenter, single-arm study. 
10.3 Ablation Assignment 
This is a single-arm study where all enrolled subjects will receive the same ablation procedure: 
transbronchial microwave ablation using the NEUWAVE FLEX MC Microwave Ablation System 
and Accessories for oligometastatic tumors (< 2cm) in the lung. There will be no blinding or 
randomization. 
10.4 Interval Windows 
Interval windows are provided in Table 1: Schedule of Assessments. No additional windows 
are planned for analysis purposes. 
10.5 Primary Endpoints and Associated Hypotheses 
The following hypotheses will be evaluated in this study: 
H0: p ≤ 0.80 vs. 
H1: p > 0.80 
where p represents the true 30-day Technique Efficacy rate of FLEX MC and 0.80 is the 
performance goal, which was determined through an internal systematic literature review and 
meta-analysis of microwave and radiofrequency ablation systems used in the treatment of lung 
tumors. 
10.6 Levels of Significance 
A one-sided significance level of 0.025 will be used to test the hypotheses above. No other 
formal hypothesis tests are planned for this study and estimation for all other endpoints will be 
performed using two-sided 95% confidence intervals. 
10.7 Analysis Sets 
The primary analysis of safety and effectiveness endpoints will be performed on the Full 
Analysis Set, defined as all subjects who are enrolled in the study and receive ablation. A Per 
Protocol analysis set will be defined as all subjects who have undergone the ablation procedure 

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Demographic and Baseline Characteristics 
Summary statistics will be provided for subject demographics and pre-operative ablation 
characteristics. 
Primary and Secondary Endpoint Analyses 
The number and percentage of tumors achieving Technique Efficacy will be summarized and 
a 95% confidence interval will be estimated. Hypothesis testing for the primary endpoint will be 
performed using the methodology described in the previous section. The number and 
percentage of tumors achieving Technical Success will also be summarized, and a 95% 
confidence interval will be estimated. Local Tumor Progression will be summarized in a similar 
manner. Only target lesions will be included in the primary endpoint analysis for Technique 
Efficacy and primary summaries of Technical Success and local Tumor Progression. Data 
collected on non-target tumors for these endpoints will be summarized separately and not 
included as part of the primary analysis. The analysis of target tumors for these three endpoints 
will also include a subject level summary that will be secondary or supportive to the tumor level 
analysis. 
Summary statistics will be provided for other secondary endpoints, as appropriate, for 
continuous or categorical variables. Local Tumor Progression Free Survival, Progression Free 
Survival, and Overall Survival will be estimated using the Kaplan-Meier method and confidence 
intervals will be provided. 
 
 
 
 
 
The number and percentage of subjects experiencing perioperative AEs (time of consent 
through 30 days of any ablation procedure), device- and procedure-related AEs (30 days post 
any ablation procedure through the end of the study or early discontinuation) and all SAEs (time 
of consent through the end of the study or early discontinuation) will be summarized by 
MedDRA system organ class and preferred term. A similar summary will also be provided for 
all SAEs from Visit 3 (the first post-ablation visit) through Visit 6 (end of study) as well as for 
the entirety of the study (Visit 1 – Visit 6). Ninety-five percent confidence intervals may be 
provided for pre-specified adverse events of interest, which are: 
1. Pneumothorax (overall and CTCAE grade > 2) 
2. Hemorrhage, bleeding requiring medical intervention (CTCAE grade > 2) 
3. Chest wall pain 
4. Pleural effusion or empyema (overall and requiring chest tube drainage) 
5. Pneumonia 
6. Pulmonary abscess 
7. Other lower-tract respiratory infection 

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8. Bronchopleural fistula. 
The Numeric Pain Rating Scale scores will be summarized with methodology consistent to the 
recommendations of the specific survey. Additional endpoints will be summarized with 
descriptive statistics. 
Plans for Interim Analysis 
There are no plans for any formal interim analyses with intent to stop the study early or to 
modify the study design. However, non-formal interim analyses are planned. The first interim 
analysis will occur after 20 subjects complete Visit 3 (30 days) and will be descriptive in nature 
only and will not impact the final analysis. The second interim analysis will occur after all 
subjects complete Visit 3 (30 days) and will include an evaluation of the primary endpoint 
against the performance goal as well as provide a summary of all baseline and procedural- 
related data. A complete summary of all safety-related data observed through the duration of 
follow-up on all subjects will also be provided. The intent of this analysis will be to support 
regulatory filing activities where appropriate. 
An additional interim analysis may be performed after all subjects have completed Visit 5 (6 
months). The final analysis will be completed once all subjects have completed Visit 6 (12 
months) and will summarize all endpoints collected during the trial. 
Complete details for all planned analyses will be included in the study SAP, which will be 
finalized prior to database lock. 
Analysis of Safety 
The analysis of safety is summarized above under Primary and Secondary Endpoint Analyses. 
Handling of Dropouts or Missing Data 
The primary endpoint analysis of Technique Efficacy at Visit 3 (30 days post-ablation) will be 
performed on observed data only. It is anticipated that dropout before the 30-day visit will be 
unlikely. However, several sensitivity analyses will be performed for the primary endpoint to 
assess the robustness of the conclusion based on observed data. This will include a worst- 
case assumption where all subjects not completing Visit 3 will be assumed to have not achieved 
Technique Efficacy. A tipping point analysis and multiple imputation will also be considered as 
alternatives to handling missing data. Time-to-event analyses will use standard censoring 
assumptions for the handling of subjects who do not complete follow-up visits. Complete details 
on sensitivity analyses for the primary and secondary endpoints will be provided in the SAP. 
Analysis of Subgroups 
At a minimum, subgroup analyses are planned to be performed by original histology and tumor 
size. Additional subgroups may be identified pending the distribution of baseline demographic 
or clinical characteristics. All subgroup analyses will be descriptive in nature and summary 
statistics will be provided for procedure-related parameters and time-to-event endpoints and 
adverse events. 

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11.0 RISKS AND BENEFITS OF THE STUDY 
This study may or may not provide any benefits to the subject. However, the data collected 
throughout the study may help to assess the effectiveness and safety of a new ablation technique: 
robotic-assisted transbronchial microwave ablation of oligometastatic tumors in the lung. 
Procedural Risks 
The procedural risks associated with the FLEX MC transbronchial ablation procedure are expected 
to be similar to those associated with diagnostic bronchoscopy as well as those associated with 
thermal ablation, which in extremely rare instances could lead to death. The Sponsor plans on 
mitigating these risks during the clinical study by careful patient selection, implementing 
intraprocedural stopping rules, and the establishment of an independent DSMB to monitor the 
study. 
Most commonly known risks for diagnostic bronchoscopy and thermal ablation procedures in the 
lung are summarized below by expected frequency: extremely rare (< 0.01%), rare (0.01% - 0.1%), 
uncommon (0.1% - 1%), common (1% - 10%), and very common (> 10%): 
 
Known Risks for: 
Diagnostic Bronchoscopy 
Known Risks for: 
TransbronchialThermal Ablation Procedures in 
the Lung 
RARE: 
• 
Cardiovascular events 
UNCOMMON: 
• 
Breathing difficulty 
• 
Vocal cord spasm 
• 
Vomiting 
• 
Dizziness 
• 
Bronchial spasm (muscle contraction of the 
airway) 
• 
Hypoxemia (shortness of breath due to low 
levels of oxygen in the blood) 
COMMON: 
• 
Pneumothorax (when air leaks into the space 
between the lungs and the chest wall) 
• Hemorrhage 
(bleeding 
requiring 
medical 
intervention) 
RARE: 
• 
Bronchopleural fistula (abnormal 
passageway that develops between the large 
airways in the lungs and the space that lines 
the lungs) 
UNCOMMON: 
• 
Air/Gas embolism (blockage or obstruction of 
a blood vessel) 
• 
Infection 
COMMON: 
• 
Pneumothorax (when air leaks into the space 
between the lungs and the chest wall) 
• 
Hemorrhage (bleeding requiring medical 
intervention) 
• 
Pleural effusion (buildup of fluid in tissues 
lining the lungs and the chest requiring tube 
drainage) 
• 
Pneumonia 
VERY COMMON 

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• 
Pain 
• 
Post-ablation syndrome 
Anesthesia Risks 
Subjects will be put under general anesthesia for the study procedure. Common risks of anesthesia 
include nausea, vomiting, dizziness, drowsiness, and shivering. These are typically mild, short-
lived symptoms that are easily managed. In rare instances, liver toxicity and cardiovascular events 
may occur. 
Intubation Risks 
There are some risks related to the intubation procedure as well as passing the bronchoscope into 
the airway. These rare risks include intubation-related airway injury, injury to teeth or dental work, 
bleeding, lung injury, and aspiration. 
Radiation Risks 
The required CT (computerized tomography) images will expose subjects to radiation. The total 
radiation exposure for each subject will be dependent on the number of CTs per subject and the 
type of CTs, as well as many other factors, such as the manufacturer of the scanning equipment. 
Conventional CT has an average radiation range 1mSv to 10mSv, while the average radiation 
range for cone beam CT is 1mSv to 5mSv. Recent pilot studies of bronchoscopic microwave 
ablation have reported a mean radiation dose of 27.8 mSv.22 This is comparable to dose exposure 
seen in other common image guided procedures, such as percutaneous coronary intervention (15 
mSv), atrial fibrillation ablation (17 mSv), and transcatheter aortic valve implantation (37 mSv).29 
The total radiation exposure to the subject during the ablation procedure will be captured. 
Device Risks 
The device risks associated with the FLEX MC procedure includes those of a diagnostic 
bronchoscopy as well as those associated with thermal ablation. These primarily include 
pneumothorax, unintended thermal damage, embolism, excessive bleeding, premature end of 
procedure, and in rare instances could lead to death. These risks have been identified and 
mitigated through the risk management tools compliant with ISO 14971 during the development of 
the MONARCH and the FLEX Systems. A summary of the more common device risks and design 
mitigations are listed below. 
 
Device Risk 
Design Mitigation(s) 
Pneumothorax 
MONARCH platform incorporates pre-procedure planning, facilitates multiple 
imaging modalities during navigation and direct visualization via camera in the 
MONARCH bronchoscope. The NEUWAVE FLEX probe tip is highly visible 
under imaging to allow proximity to the pleura to be assessed throughout the 
procedure. 
Unintended thermal 
damage due to 
ablation zone shape 
NEUWAVE FLEX System includes a Time-Power onscreen ex-vivo ablation 
zone reference for the user. NEUWAVE FLEX System uses CO2 gas to cool 
the FLEX probe while continuously monitoring temperature at three locations 
on the probe. 

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Unintended thermal 
damage due to 
probe placement 
MONARCH platform incorporates pre-procedure planning, multiple imaging 
modalities during navigation and direct visualization via camera in the 
MONARCH bronchoscope. The NEUWAVE FLEX probe is highly visible under 
imaging to allow probe location to be assessed throughout the procedure. 
Embolism due to 
CO2 cooling gas leak 
NEUWAVE FLEX Probe is designed and tested to safely contain high pressure 
CO2 gas in a sealed system. In addition, the user is required to perform a 
functional probe test that includes a CO2 leak check. The system will not allow 
energy delivery if a leak is detected. 
Excessive bleeding 
due to organ 
laceration 
MONARCH facilitates multiple imaging modalities during navigation and 
includes direct visualization via camera in the MONARCH bronchoscope. 
NEUWAVE FLEX Probe tips are coated with non-stick material designed to 
reduce insertion/removal force and help prevent ablated tissue adhesion to the 
probe tip. 
Benefits 
In patients with a controlled primary malignancy who develop oligometastatic disease in the lung 
for which their treatment team believes local tumor control is necessary, FLEX MC provides a 
treatment option via complete tumor ablation. This option may minimize some of the risks 
associated with other options to achieve local control including surgery, SBRT, or percutaneous 
approaches. In addition, FLEX MC may offer patients less of a decrement in health-related quality 
of life as compared to other currently available therapies. The risks of FLEX MC are those 
associated with known risks of bronchoscopy and thermal ablation, which are well established 
procedures. With the existing robust risk mitigations in place (described above), the Sponsor’s 
assessment is that the risks are adequately analyzed, evaluated, controlled, verified for 
effectiveness, and the benefits outweigh the risks in this patient population. 

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12.0 ASSESSMENT OF SAFETY 
Subjects will be evaluated for AEs and SAEs from the time of consent based on the following 
descriptions: 
• 
Perioperative AEs will be captured from the time of subject consent through 30-days post 
any ablation procedure (i.e., the original ablation as well as any re-ablation) regardless of 
relationship to the study device or procedure. 
• 
AEs that are deemed related to the study device or procedure will be captured 30-days 
post any ablation procedure (i.e., the original ablation as well as any re-ablation) through 
the end of the study or early discontinuation. 
• 
Serious adverse events (SAEs) will be captured from the time of subject consent through 
the end of the study or early discontinuation regardless of relationship to the study device 
or procedure. 
Investigators should remind study subjects to notify and/or see them or their study team first, when 
possible, if they experience any adverse events versus seeking treatment elsewhere. 
Ongoing Review 
The Sponsor will also review complications periodically, as per the study’s Safety Management 
Plan. 
12.1 Adverse Events 
Adverse Event (AE) 
For this study, an adverse event is defined as any untoward medical occurrence, unintended 
disease or injury, or any untoward clinical signs, including an abnormal laboratory finding, in a 
subject whether or not related to the study device or procedure. 
Expected Morbidity/Anticipated Adverse Events 
An expected morbidity/procedural complication is defined as an AE that is known to be common 
or usual in nature, severity, or incidence during ablation of the lung. 
Serious Adverse Event (SAE) 
It is the Investigator’s responsibility to determine the “seriousness” of an AE using the protocol 
defined terms below. An SAE is an AE that results in one or more of the following for this study: 
• Death; 
• Serious deterioration in the health of the subject that resulted in any of the following: 
o Life threatening illness or injury; 
o Permanent impairment of a body structure or a body function; 
o Hospitalization or prolongation of patient hospitalization; 
o Medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function; or 
o Chronic disease. 

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• Fetal distress, fetal death, or a congenital physical or mental impairment or birth defect. 
 
Notes: 
1. Progression of the disease under study should not be reported as an SAE. 
2. “Death” should not be reported as an AE. The cause of death should be reported as an 
AE. The only exception is “Sudden Death” when the cause is unknown. 
3. Planned hospitalization for a pre-existing condition should not be considered an SAE. 
4. A procedure required by the protocol should not be considered an SAE, unless the 
subject experiences a serious deterioration in health or hospitalization is prolonged. 
The Sponsor will review all applicably reported AEs and SAEs according to the current Safety 
Monitoring Plan. 
Unanticipated Adverse Device Event (UADE) 
Any SAE caused by, or associated with, the device, if that event was not previously identified 
in nature, severity, or degree of incidence in the protocol or Investigator Brochure, or any other 
unanticipated serious problem associated with the device that relates to the rights, safety, or 
welfare of subjects. 
Investigators are required to submit a report of a UADE to the Sponsor and the reviewing IRB 
as soon as possible, but no later than 72 hours after the investigator first becomes aware of 
the event. 
Sponsors must immediately conduct an evaluation of a UADE and report the results of the 
evaluation to FDA, all reviewing IRBs/ECs, and participating investigators within 10 working 
days after the Sponsor first receives notice of the event. 
SEVERITY OF ADVERSE EVENTS 
It is the Investigator’s responsibility to assess the severity of an AE. AE severity in this study 
will be determined using the current version of the Common Terminology Criteria for Adverse 
Events (CTCAE). The CTCAE uses Grades 1 through 5 with unique clinical descriptions of 
severity for each AE based on the general guidelines, provided below. Please note that a 
change in severity, or grade, may constitute a new reportable AE. 
• Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; 
intervention not indicated; 
• Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age- 
appropriate instrumental activities of daily living (ADL); 
• Grade 3: 
Severe or medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
ADL (e.g., bathing, dressing, and undressing, feeding self, using the toilet, taking 
medications, and not bedridden); 
• Grade 4: Life-threatening consequences; urgent intervention indicated; and 
• Grade 5: Death related to AE. 
Note: A semi-colon indicates “or” within the description of the grade. 

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RELATIONSHIP OF ADVERSE EVENTS 
It is the Investigator’s responsibility to assess the relationship between all AEs and SAEs and 
the study procedure and device. The following guidelines should be used in determining the 
relationship of an AE to a device, study procedure, or other causality: 
 
Not Related 
Relationship to the device or procedure can be excluded when: 
• The event has no temporal relationship with the use of the device or 
the procedures related to the device; 
• The event does not follow a known response pattern to the device 
or procedure (if the response pattern is previously known) and is 
biologically implausible; 
• The discontinuation of the device application or the reduction of the 
level 
activation/exposure 
(when 
clinically 
feasible) 
and 
reintroduction 
of 
its 
use 
(or 
increase 
of 
the 
level 
of 
activation/exposure), does not impact the event; 
• The event involves a body-site or an organ that cannot be affected 
by the device or procedure; 
• The event can be attributed to another cause (e.g., an underlying or 
concurrent illness/clinical condition, an effect of another device, 
drug, treatment, or other risk factors); and 
• The event does not depend on a false result given by the device 
used for diagnosis, when applicable. 
Note: To establish the non-relatedness, not all the criteria listed above 
might be met at the same time, depending on the type of 
device/procedure and the event. 
Possible* 
The relationship with the use of the device or procedure is weak but 
cannot be ruled out completely. Alternative causes are also possible (e.g., 
an underlying or concurrent illness/condition and/or an effect of another 
device, drug, or treatment). Cases where relatedness cannot be 
assessed, or no information has been obtained should also be classified 
as possible. 
Probable* 
The relationship with the use of the device or procedure seems relevant 
and/or the event cannot reasonably be explained by another cause. 
Causal 
Relationship* 
The event is associated with the device or with procedure beyond 
reasonable doubt when: 

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• The event is a known side effect of the product category the device 
belongs to or of similar device and procedures; 
• The 
event 
has 
a 
temporal 
relationship 
with 
the 
device 
uses/application or procedures; 
• The event involves a body-site or organ that: 
▪ The device or procedures are applied to; or 
▪ The device or procedures have an effect on. 
• The event follows a known response pattern to the device (if the 
response pattern is previously known); 
• The discontinuation of the device application (or reduction of the 
level of activation/exposure) and reintroduction of its use (or 
increase of the level of activation/exposure), impact on the event 
(when clinically feasible); 
• Other possible causes (e.g., an underlying or concurrent 
illness/clinical condition and/or an effect of another device, drug, or 
treatment) have been adequately ruled out; 
• Harm to the subject is due to error in use; and 
• The event depends on a false result given by the device used for 
diagnosis, when applicable. 
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. 
*Indicates definitions of relationship that qualify to be recorded as part of the study for AEs only that occur more than 
30-days any ablation procedure. All SAEs, regardless of relationship, will be collected. 
 
12.2 Reporting Adverse Events 
The Investigator is required to report all applicable non-serious AEs to the Sponsor within 14 
days of becoming aware of the event. 
All SAEs and UADEs, regardless of relationship to the study device or procedure, are to be 
reported as soon as possible, but no later than 72 hours after becoming aware of the event. 
The study site will report applicable AEs and all SAEs to the Sponsor by entering the event into 
the EDC system via the AE eCRF, which will trigger an automated email to the Sponsor. 
Additional information, including the Investigator’s assessment, may be added to the eCRF 
later. Any necessary medical management of the event will be recorded in the subject’s 
medical record/source document. If the Sponsor requires supporting documentation or other 
information, the Sponsor will contact the study site. 
Data related to AEs and SAEs will be collected until event resolution, until the event is 
considered stable, or until all attempts to determine the resolution of the event are exhausted. 

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All AEs and SAEs that are unresolved at study completion (or early termination) will be 
recorded as ongoing at study end. 
The report of an AE or SAE by a site does not constitute an admission that study personnel or 
the user facility (hospital/clinic) caused or contributed to the event. The study site is responsible 
for submitting AEs/SAE to the reviewing IRB/EC, per their IRB/EC procedures. 
In addition, the following information should be recorded: 
• 
Onset date. 
• 
Resolution date or date of death. 
• 
Severity of the event. 
• 
Action taken. 
• 
Event status (ongoing at study end or resolved). 
• 
Relationship of AE to the study devices. 
• 
Relationship of AE to the study procedures. 
• 
Indication of seriousness. 
• 
Was AE anticipated. 
• 
Time of AE (navigation, pre-ablation probe placement, ablation, post-ablation). 
A report of a subject death or severe hemorrhage requiring intervention beyond local therapy 
(i.e., Nashville > grade 2 or CTCAE > grade 2) within 30 days of tumor ablation procedure will 
put enrollment on hold and require an investigation to determine if the death or hemorrhage 
was related to the ablation procedure. The investigation will be led by the independent Data 
Safety Monitoring Board, DSMB, described in Section 12.3. 
Based on ongoing reviews of the data, additional stopping rules may be introduced as deemed 
appropriate. 
12.3 Data Safety Monitoring Board 
An independent DSMB will be commissioned to review, on a regular basis, safety data from 
the study. The DSMB will advise the Sponsor regarding the continuing safety of subjects and 
those yet to be recruited to the study. The initial DSMB review of safety data will be conducted 
after five subjects have been ablated and completed the 30-day follow-up visit. Additional 
DSMB reviews will occur after 10 and 20 subjects have been ablated and completed the 30- 
day follow-up visit. After the review of the initial 20 subjects, the DSMB will determine the 
appropriate continued frequency for their reviews, which will continue for the duration of the 
study. Based on accumulating safety data from the study, the DSMB may recommend whether 
to continue, suspend, modify, or stop the study. 
At the conclusion of the review of all enrolled and ablated subjects, the DSMB will also give a 
final assessment of the safety of the procedure. The composition, responsibilities, frequency of 
DSMB meetings, handling of emergency situations, and documentation of DSMB meetings is 
specified in the DSMB Charter. 
Additionally, the DSMB will review all reported deaths. A report of death or severe hemorrhage 
requiring intervention beyond local therapy (i.e., Nashville > grade 2 or CTCAE > grade 2) 
within 30 days of the procedure will put enrollment on hold and require review by the DSMB to 

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determine if the death or hemorrhage was related to the ablation procedure. The DSMB will 
determine whether the study may resume enrollment or state other necessary conditions or 
recommendations to resume enrollment. 
A document outlining membership and responsibilities will be described in detail in a separate 
charter, which will be finalized prior to the first subject being ablated. 

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13.0 PRODUCT COMPLAINT DEFINITION 
A product complaint is defined as any written, electronic, or oral communication that alleges 
deficiencies related to the identity, labeling, quality, durability, reliability, safety, effectiveness, or 
performance of a device (21CFR 820.3 (b)). A product complaint may or may not be associated 
with an AE/SAE. 
Product complaints may include, but are not limited to: 
1. Product contamination; 
2. Defective components; 
3. Poor packaging or product mix-up; 
4. Device malfunction (the failure of a device to perform as intended for this study); 
5. Labeling concerns; and 
6. User errors. 
Reporting Product Complaints 
All product complaints, malfunctions, or failures related to devices in the procedure (including 
both NeuWave and Auris devices) shall be documented in the Product Complaints eCRF in a 
timely manner after becoming aware of the event. The eCRF completion will trigger an 
automated notification email to the Sponsor. 
The device involved in the complaint should be retained on site. A Sponsor representative will 
organize collection of the device for evaluation, as needed. 

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14.0 TRAINING 
All investigators (PIs or Sub-Investigators) who will be performing the FLEX MC ablation 
procedure are required to undergo FLEX MC Training. The training will include lectures on 
microwave ablation of the lung, probe placement, margin planning and assessment, and review 
of cases from the previous Sponsor study on transbronchial microwave ablation using the FLEX 
System.23 The training will also involve a human, simulated, or synthetic tissue lab to 
demonstrate the FLEX MC workflow, probe placement using augmented fluoroscopy and CBCT 
confirmation, scope and probe retraction workflow, and reading post-ablation CBCT images. A 
FLEX MC Training Completion Form will be signed upon completion of the training course and 
filed in the Investigator Site File. 
In addition to the training, per the Investigator Selection Criteria, all investigators who will be 
performing the FLEX MC ablation procedure are also required to complete a minimum of 20 
MONARCH diagnostic bronchoscopy procedures, with at least five of those cases using CBCT, 
and demonstrate proficiency prior to enrolling subjects into the trial. 
The Sponsor will provide access to a Product Development Specialist and/or a Medical Specialist 
experienced in this procedure for the treating physician during the case, as needed. This will be 
mandatory for the first case at each site and may be continued at the request of the site PIs for 
subsequent cases. 
If MONARCH is not commercially available at a site to complete the required minimum 20 
diagnostic bronchoscopy procedures (with at least five of those cases using CBCT), the 
investigator may complete these required lead-in cases, under this protocol per the MONARCH 
IFU/User Manual. Subjects will consent for their diagnostic bronchoscopy as a lead-in case for 
this study. Lead-in cases are not treated (ablated) with the FLEX MC device at the time of the 
diagnostic procedure. Should the patient later qualify for the FLEX MC study, the patient will then 
be consented for FLEX MC study participation. 
After the diagnostic bronchoscopy with MONARCH, the investigator will follow these subjects to 
the first follow up time point per the site’s SOC (either telephone call or clinical visit), or within 7 
days, to note any potential adverse events related to the diagnostic procedure, which will be 
reported the same way as the FLEX MC adverse events. Any data collected from these lead-in 
cases will be in support of appropriate event reporting. 
The investigator may also perform additional “lead-in” diagnostic cases during the course of the 
study enrollment, if deemed warranted by the investigator to maintain proficiency with the 
MONARCH and/or CBCT workflow. 

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15.0 DATA AND PUBLICATION POLICIES 
Publication and authorship policies should be determined and aligned with the clinical study 
agreement executed between the operating company and the clinical site. Publication of the 
results of this study will be governed by Johnson & Johnson publication policies, including current 
and applicable Medical Device Publication Policy. Any presentation, abstract, or manuscript will 
be made available for review by the Sponsor prior to submission. Licensing agreements or 
copyrights applying to tools, work products or intellectual property used during the study should 
be observed and clearly displayed on study documentation and publications, wherever 
appropriate. 
All manuscripts of data obtained from this clinical study will be reviewed and approved by the 
Sponsor, and each author, prior to any submission. Current and applicable Medical Device 
Publication Policy will be followed. The Sponsor will require a written agreement for any external 
author(s) prior to initiating any publication. All authors must disclose financial or personal 
affiliations that could be considered a conflict of interest. 

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16.0 SUPPLEMENTS 
16.1 Appendix 1: Numeric Pain Rating Scale 
 
The Numeric Pain Rating Scale can be administered verbally (therefore also by telephone) or 
graphically for self-completion. Administers will ask respondents to “indicate the numeric value 
on the segmented scale that best describes their pain intensity right now with 0 being NO PAIN, 
5 being MODERATE PAIN, and 10 being WORST POSSIBLE PAIN”. 
 

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16.2 Appendix 2: Nashville Scale for Bleeding 
 
 

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16.3 Glossary 
 
 
Acronyms/ 
Abbreviations 
Terms 
ADL 
Activities of Daily Living 
AE 
Adverse Event 
APTT 
Activated Partial Thromboplastin Time 
BMI 
Body Mass Index 
CBC 
Complete Blood Count 
CBCT 
Cone Beam Computed Tomography 
CEA 
Carcinoembryonic Antigen 
CFR 
Code of Federal Regulations 
CO2 
Carbon Dioxide 
CT 
Computed Tomography 
CTCAE 
Common Terminology Criteria for Adverse Events 
DICOM 
Digital Imaging and Communications in Medicine 
DLCO 
Diffusing [capacity of the] Lung [for] Carbon Monoxide 
DSMB 
Data Safety Monitoring Board 
EBRT 
External Beam Radiation Therapy 
EC 
Ethics Committee 
ECOG 
Eastern Cooperative Oncology Group 
eCRF 
Electronic Case Report Form 
EDC 
Electronic Data Capture 
EKG 
Electrocardiogram 
ENB 
Electromagnetic Navigation Bronchoscopy 
EORTC 
European Organization for the Research and Treatment of Cancer 
EWC 
Extended Working Channel 
FDA 
Food and Drug Administration 
FEF 
Forced Expiratory Flow 
FEV1 
Forced Expiratory Volume 
FRC 
Functional Residual Capacity 

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Acronyms/ 
Abbreviations 
Terms 
FVC 
Forced Vital Capacity 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practice 
HRQOL 
Health-Related Quality of Life 
IB 
Investigator Brochure 
ICF 
Informed Consent Form 
ID 
Identification 
IDE 
Investigational Device Exemption 
IFU 
Instructions for Use 
IGTA 
Image-Guided Thermal Ablation 
INR 
International Normalized Ratio 
IRB 
Institutional Review Board 
LDH 
Lactate Dehydrogenase 
LOS 
Length of Hospital Stay 
LTP 
Local Tumor Progression 
LTPFS 
Local Tumor Progression Free Survival 
MDT 
Multidisciplinary Team 
MedDRA 
Medical Dictionary for Regulatory Activities 
MRI 
Magnetic Resonance Imaging 
MWA 
Microwave Ablation 
NSAID 
Nonsteroidal Anti-Inflammatory Drug 
NSCLC 
Non-Small Cell Lung Cancer 
OS 
Overall Survival 
PAP 
Positive Airway Pressure 
PDM 
Power Distribution Module 
PET 
Positron Emission Tomography 
PFS 
Progression Free Survival 
PFT 
Pulmonary Function Test 
PI 
Principal Investigator 
PT 
Prothrombin Time 

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Acronyms/ 
Abbreviations 
Terms 
RAB 
Robotic-Assisted Bronchoscopy 
RFA 
Radiofrequency Ablation 
RV 
Residual Volume 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SBRT 
Stereotactic Body Radiation Therapy 
SOC 
Standard of Care 
SPO2 
Oxygen Saturation 
TLC 
Total Leukocyte Count 
UADE 
Unanticipated Adverse Device Event 
US 
United States 

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17.0 SCIENTIFIC REFERENCES 
 
 
 
 
 
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3 Pastorino U, Buyse M, Friedel G, et al. Long-term results of lung metastasectomy: prognostic analyses based 
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5 Kim HK, Cho JH, Lee HY, et al. Pulmonary metastasectomy for colorectal cancer: how many nodules, how 
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16 In-house analysis: Systematic review and Meta analysis of outcomes associated with percutaneous ablation 
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