AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions
Phase: NA
Conditions: Lung Diseases
Sponsor: Philips Clinical & Medical Affairs Global

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
Doc ID: XCY607-130895 
Rev: 04 
Date: 2024-Jun-19 
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Author:  
Sander Langereis 
 
PEPF: Clinical Operations Clinical Research Associate (CRA) 
 
 
Sponsor:  
Philips Medical Systems Nederland BV 
Veenpluis 6  
5684 PC Best 
The Netherlands 
 
Department:  
 
 
Philips IGT-S Clinical Science & Medical Affairs. 
 
 
 
Protocol version and date:  
 
Revision 04 (2024-June-19) 
 
Approval 
Name 
Role 
Date 
(Electronic) Signature 
Kevin Najarian 
PEPF: Biostatistician 
 
Pim van Lochem 
PEPF: Clinical Development 
 
Joris de Groot 
Clinical Operations Lead 
 
Yesheshvi Anush Puvvada  Regulatory Affairs Officer 
 
Controlled Document is approved when all approvers have signed. Approval and effective date are the dates of the latest signature. 
 
 
 
 

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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Revision History 
Revision 
Revision Date 
Author 
Changes/Comments 
00 
2022-Nov-22 
Sander Langereis 
Initial version 
 
01 
2022-Dec-14 
Sander Langereis 
(Cross-)references issues fixed 
IFU revision updated 
02 
2023-June-02 
Sander Langereis 
Update of: study timelines, wording on safety 
reporting, references IFU and IB, Risks and 
benefits, table of anticipated adverse device 
effects 
03 
2023-Jul-11 
Sander Langereis 
Clarification major protocol deviations section 8.1 
04 
2024-Jun-19 
Sander Langereis 
Increase sample size, IFU revision updated due to 
iteration device, administrative change to address 
error in description intra-procedural study practice 
 
Open Issues 
None 
 
 

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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Date: 2024-Jun-19 
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Table of Contents 
 
Approval ..............................................................................................................................................................1 
Revision History ..................................................................................................................................................2 
Open Issues ........................................................................................................................................................2 
Table of Contents ...............................................................................................................................................3 
1. 
Document Introduction ................................................................................................................................5 
1.1. 
Purpose ...............................................................................................................................................5 
1.2. 
Scope ..................................................................................................................................................5 
1.3. 
References..........................................................................................................................................5 
1.4. 
Definitions & Abbreviations .................................................................................................................5 
2. 
Summary.....................................................................................................................................................7 
3. 
Device Description ................................................................................................................................... 11 
3.1. 
Summary description of the investigational device.......................................................................... 11 
3.2. 
Intended Purpose ............................................................................................................................ 12 
3.2.1. 
Indications for Use/medical purpose ....................................................................................... 12 
3.2.2. 
Intended Operator Profile ........................................................................................................ 12 
3.2.3. 
Clinical Environment ................................................................................................................ 13 
3.2.4. 
General Safety and Effectiveness ........................................................................................... 13 
3.2.5. 
Contraindications ..................................................................................................................... 13 
3.2.6. 
Operating principle ................................................................................................................... 13 
3.2.7. 
Necessary training and experience needed to use the investigational device ........................ 13 
3.3. 
Materials that will be in contact with tissues or body fluids ............................................................. 13 
3.4. 
Device Traceability .......................................................................................................................... 13 
4. 
Justification for the design of the study ................................................................................................... 13 
4.1. 
State-of-the-art ................................................................................................................................. 13 
4.2. 
Evaluation of (pre)clinical testing ..................................................................................................... 15 
4.3. 
Evaluation of clinical data ................................................................................................................ 16 
5. 
Risks and benefits of the investigational device and feasibility clinical investigation .............................. 17 
5.1. 
Benefit-to Risk rationale ................................................................................................................... 18 
6. 
Objectives ................................................................................................................................................ 18 
6.1. 
Primary objective ............................................................................................................................. 18 
6.2. 
Secondary objective(s) .................................................................................................................... 18 
7. 
Study Design ........................................................................................................................................... 19 
7.1. 
General ............................................................................................................................................ 19 
7.1.1. 
Endpoints ................................................................................................................................. 19 
7.1.2. 
Maintenance and calibration .................................................................................................... 20 
7.1.3. 
Operators / users ..................................................................................................................... 20 
7.2. 
Investigational device exposure and comparators .......................................................................... 20 
7.3. 
Subjects ........................................................................................................................................... 21 
7.3.1. 
Inclusion and exclusion criteria ................................................................................................ 21 
7.3.2. 
Enrollment and duration ........................................................................................................... 21 
7.3.3. 
Number of subjects .................................................................................................................. 22 
7.3.4. 
Procedure for the replacement of subjects .............................................................................. 22 
7.3.5. 
Subject withdrawal ................................................................................................................... 22 
7.4. 
Procedures....................................................................................................................................... 22 
7.5. 
Monitoring Plan ................................................................................................................................ 23 
8. 
Statistical considerations ......................................................................................................................... 24 
8.1. 
Analysis Populations ........................................................................................................................ 24 
8.2. 
Sample Size Justification ................................................................................................................. 25 
8.3. 
General Consideration ..................................................................................................................... 25 
8.4. 
Subject Disposition .......................................................................................................................... 25 
8.5. 
Demographics and Baseline Characteristics ................................................................................... 25 
8.6. 
Primary objective ............................................................................................................................. 26 
8.7. 
Secondary objectives ....................................................................................................................... 26 

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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8.7.1. 
Secondary objective: Intuitiveness of AirWaze Features ........................................................ 26 
8.7.2. 
Secondary objective: Quantitative and qualitative assessment of developed algorithms ....... 27 
8.7.3. 
Secondary objective: Quality of the Interventional plan .......................................................... 27 
8.7.4. 
Secondary objective: Confidence level .................................................................................... 28 
8.7.5. 
Secondary objective: Cognitive load during navigation ........................................................... 28 
8.7.6. 
Secondary objective: Radiation exposure for patients and staff ............................................. 28 
8.7.7. 
Secondary objective: Adverse events ..................................................................................... 29 
8.7.8. 
Secondary objective: Adverse Device Effects ......................................................................... 29 
8.7.9. 
Secondary objective: Device Deficiencies ............................................................................... 29 
9. 
Data management ................................................................................................................................... 30 
9.1. 
Retention period .............................................................................................................................. 30 
10. Amendments to the Feasibility Clinical Investigation Protocol ................................................................ 30 
11. Deviations from the feasibility clinical investigation protocol ................................................................... 31 
12. Device accountability ............................................................................................................................... 31 
13. Statements of compliance ....................................................................................................................... 31 
14. Informed consent process ....................................................................................................................... 32 
14.1. 
Incapacitated subjects ..................................................................................................................... 32 
14.2. 
Minors .............................................................................................................................................. 32 
14.3. 
Subject unable to give informed consent in case of emergency treatment ..................................... 32 
15. Adverse event reporting ........................................................................................................................... 32 
15.1. 
Definitions ........................................................................................................................................ 32 
15.2. 
Reporting ......................................................................................................................................... 34 
15.3. 
Anticipated adverse device effects .................................................................................................. 36 
15.4. 
Unreportable adverse events........................................................................................................... 38 
16. Vulnerable population .............................................................................................................................. 38 
17. (Early) termination or suspension of the feasibility clinical investigation ................................................. 38 
18. Publication policy ..................................................................................................................................... 39 
19. Bibliography ............................................................................................................................................. 40 
Appendix I: System Usability Scale (SUS) of AirWaze ................................................................................... 41 
Appendix II: CBCT-FS compared to CBCT ..................................................................................................... 42 
Appendix III: Semi-structured Questionnaires – Assessment of the intuitiveness of AirWaze features ......... 43 
Appendix IV: Semi-structured Questionnaire for quantitative and qualitative assessment of the developed 
algorithms ........................................................................................................................................................ 45 
Appendix V: AirWaze Procedural Analysis ...................................................................................................... 48 
Appendix VI: Radiation Dose of CBCT-guided NB .......................................................................................... 53 
Appendix VII: Roles, responsibilities and qualifications of Investigators ......................................................... 55 
 
 

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
Doc ID: XCY607-130895 
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Date: 2024-Jun-19 
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1. 
Document Introduction 
1.1. 
Purpose 
This document describes the minimum amount of information to be included in the feasibility clinical 
investigation protocol based on the regulations to ensure safety and well-being of human subjects and users.  
1.2. 
Scope 
The AirWaze investigational device (version 1.1, Philips Medical Systems), hereafter referred to as AirWaze, 
has been designed to reduce the cognitive load and therewith overall procedural accuracy of CBCT guided 
navigation bronchoscopy (NB) for lung interventions. The main goal of the AirWaze prototype is to improve the 
ease-of-use of CBCT-guided NB to help improve widespread implementation and overall accuracy of this novel 
technology for minimally-invasive lung interventions. This widespread implementation of CBCT guided NB is 
necessary for coping with the increasing number of patients with pulmonary lesions suspicious of malignancy. 
 
The software tools of the AirWaze investigational device (version 1.1) have an improved user interface 
compared to a previously clinically evaluated AirWaze prototype (version 1.0) which now consists of a 
procedural planning module, an image-guided navigation module with augmented fluoroscopy, and dedicated 
low dose radiation imaging protocols for tool-in-lesion confirmation. Benefits may include a reduction in the 
procedure time, less radiation exposure for the patient, and less cognitive load for the physicians during 
navigation bronchoscopy, while maintaining patient safety and a high diagnostic accuracy for peripheral 
pulmonary nodules. 
 
The clinical investigation protocol (CIP) is aimed to assess the clinical and technical feasibility of the AirWaze 
tools for CBCT-guided lung interventions. This feasibility clinical investigation protocol applies to study: 
“AirWaze – easy and advanced tools for CBCT-guided lung interventions”. 
1.3. 
References  
Reference 
Identification 
Title / additional remarks 
[REF-1] 
XCY607-131101_rev02 
Investigator Brochure AirWaze 
[REF-2] 
XCY607-131132_r03 
Instructions for Use (IFU) AirWaze clinical 
 
1.4. 
Definitions & Abbreviations 
Term 
Description 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
AF 
Augmented Fluoroscopy 
ASA  
American Society of Anesthesiologists  
CA 
Competent Authority 
CBCT 
Cone-Beam Computed Tomography 
CBCT-FS 
Cone-Beam Computed Tomography-FluoroSweep 
CE 
Conformité Européenne (European Conformity) 
CFR 
Code of Federal Regulation 
CL 
Confidence Level 
(e-)CRF 
(Electronic) Case Report Form 
CIP 
Clinical Investigation Protocol 
CRO 
Contract Research Organization 
DAP 
Dose Area Product 
(r-)EBUS 
(radial-)Endobronchial Ultrasound 
ENB 
Electromagnetic Navigation Bronchoscopy 
EU 
European Union 
EU-MDR 
Medical Device Regulation (EU) 2017/745 of the European Parliament  

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
Doc ID: XCY607-130895 
Rev: 04 
Date: 2024-Jun-19 
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Term 
Description 
FDA 
Food Drug Administration 
FS 
FluoroSweep 
HCP 
Health Care Professional 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
MEC 
Medical Ethic Committee 
OR 
Operating Room 
PoC 
Proof-of-Concept 
PPN 
Peripheral Pulmonary Nodule 
NOACs 
Novel Oral Anticoagulants 
NB 
Navigation Bronchoscopy 
RAB 
Robot assisted bronchoscopy 
ROSE 
Rapid on-site evaluation 
SAE 
Serious Adverse Event 
SURG-TLX 
Surgical Task-load Index 
SUS 
System Usability Scale 
TLCA  
Tool-in-lesion confirmation accuracy  
TSM 
touch-screen module 
TTNA 
transthoracic needle aspiration 
UMC 
University Medical Centre 
USADE 
Unanticipated Serious Adverse Device Effect 

 
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Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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2. 
Summary 
 
Identification of investigational device 
The AirWaze investigational device (version 1.1, Philips Medical Systems, The Netherlands) has been 
developed for CBCT-guided bronchoscopic interventions in order to reduce the operator's cognitive load 
and therewith improve the overall accuracy for Cone-Beam Computed Tomography (CBCT)-guided 
navigation bronchoscopy (NB) procedures. The AirWaze software tools are designed to facilitate the 
physician to plan the envisioned pathway to the target lesion, to navigate devices to the target lesion under 
image-guidance, and to confirm tool-in-lesion positioning for subsequent interventions.  
 
The AirWaze investigational device (version 1.1) consists of the following features:   
  
1. Advanced planning software that supports bronchoscopists in optimally preparing the NB procedure 
by reconstructing the patient-specific airways, proposed navigation trajectory and target lesion in 
3D from a pre-procedural CT scan; 
2. Augmented fluoroscopy based upon an intra-procedurally acquired CBCT that provides in-room 
image-guided, real-time navigation by augmenting the fluoroscopy imaging with an overlay of the 
airways, proposed navigation trajectory, and target lesion;   
3. Automatic device detection that visualizes the endobronchial catheter and lesion to support device-
in-lesion assessment; 
4. Directional guidance software that provides guidance for accurate device navigation, positioning, 
and device-in-lesion confirmation;  
5. CBCT-FluoroSweep, a dedicated low dose radiation protocol, that supports pulmonologists in 
acquiring lower radiation dose tool-in-lesion confirmation scans instead of the conventionally 
performed CBCT scan. 
 
Study design 
This is a prospective, single center, feasibility clinical investigation at the Radboud University Medical Centre 
that is sponsored by Philips Medical Systems (Best, The Netherlands). This study involves the assessment 
of the system usability of the AirWaze investigational device and the accuracy of the tool-in-lesion 
confirmation scan CBCT-FluoroSweep compared to the conventional CBCT. 
 
Objectives  
Primary objective 
The primary objectives of this feasibility clinical investigation are to assess the overall usability of the Philips 
AirWaze investigational device as measured by the System Usability Score (SUS), and the accuracy of the 
tool-in-lesion confirmation scan CBCT-FluoroSweep compared to the conventional CBCT. 
 
Secondary objectives 
The secondary objectives of this feasibility clinical investigation are: 
 
- 
To assess intuitiveness of the individual AirWaze features by the physicians. 
- 
To assess performance of the following algorithms: 
a) Segmentation of the bronchial tree on pre-procedural CT. 
b) Elastic registration of the intraoperative CBCT scans with preprocedural CT scan.  
c) Automatic device detection on intraoperative CBCT scans. 
 
- 
To assess the quality of the interventional plan (pre-procedural planning). 
- 
To assess the confidence levels of interventional pulmonologists while using AirWaze (pre-
procedural planning). 
- 
To assess the intraprocedural cognitive load of CBCT-guided NB.  
- 
To determine the radiation exposure for patients and staff. 
- 
Report all adverse events, adverse device effects and device deficiencies. 
 

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
Doc ID: XCY607-130895 
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Endpoints  
Primary endpoint 
 
- 
System Usability Score (SUS) of AirWaze investigational device. 
- 
Accuracy of the tool-in-lesion confirmation scan CBCT-FS compared to the conventional CBCT 
(gold-standard) based on tool-in-lesion definitions and usefulness of the scans to guide to the lesion. 
 
Secondary endpoints 
 
The secondary endpoints of this clinical feasibility investigation are: 
- 
Semi-structured questionnaires to assess intuitiveness of AirWaze features for CBCT-guided biopsy 
of peripheral pulmonary nodules.   
- 
Quantitative and qualitative assessment of developed algorithms: 
a) Segmentation bronchial tree on pre-procedural CT. 
b) Elastic registration of the intraoperative CBCT scans with preprocedural CT scan. 
c) Automatic device detection on intraoperative CBCT scans.  
- 
The quality of the interventional planning utilizing the AirWaze planning software assessed by 
semi-structured questionnaires. 
- 
Confidence levels of pulmonologists regarding: (i) the localization of the lesion and planned 
navigation trajectory; (ii) reaching the first pulmonary lesion based on the planning assessed by 
semi-structured questionnaires. 
- 
The cognitive load of pulmonologists during CBCT-guided navigation to the first pulmonary lesion 
assessed by semi-structured questionnaires. 
- 
Radiation exposure for patients and staff. 
- 
Adverse events, adverse device effects and device deficiencies. 
Main inclusion criteria 
In order to be eligible to participate in this study, a subject must meet the following criteria:  
• 
Age 18 years or older at the time of informed consent. 
• 
ASA physical status between 1 and 3. 
• 
Subject is willing and able to give written informed consent for clinical investigation participation 
prior to the procedure. 
• 
Subject has a pulmonary lesion with an indication for diagnostic evaluation following current clinical 
guidelines and/or as decided by multi-disciplinary team consultation. 
• 
Suitable for CBCT-guided endobronchial nodule biopsy under general anaesthesia. 
• 
Pre-procedural (PET-)CT scan is available prior to the CBCT-NB intervention. 
 
Main exclusion criteria 
A potential subject who meets any of the following criteria will be excluded from participation in this study: 
• 
Aged 17 or younger at the time of informed consent. 
• 
ASA physical status is equal to and greater than 4. 
• 
Not willing or not able to give informed consent. 
• 
Does not indicate diagnostic evaluation with navigation bronchoscopy. 
• 
Not suitable for CBCT-guided endobronchial nodule biopsy via navigation bronchoscopy under 
general anaesthesia.  
• 
There is no recent pre-procedural (PET-)CT scan available. 
• 
Known bleeding disorders. 
• 
Contra-indication for temporary interruption of the use of anticoagulant therapy, such as 
acenocoumarol, warfarin, therapeutic dose of low molecular weight heparins, clopidogrel, or 
analogues, NOACs). 
• 
Known allergy for lidocaine or other allergies interfering with the procedure. 
• 
Uncontrolled pulmonary hypertension. 
• 
Recent and/or uncontrolled cardiac disease. 

 
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AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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• 
Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for 
any reason such that endobronchial access is considered unsafe). 
• 
Potentially confounding drug or device trial during the clinical study. Co-enrollment in concurrent 
trials may be allowed provided pre-approval is obtained from the Philips Clinical Study Manager. 
• 
All vulnerable subjects, such as immune-compromised subjects, subjects lacking the capacity to 
provide consent, patients in emergencies, pregnant or breastfeeding women, or any other subject 
who meets exclusion criteria, according to applicable national laws, if any. 
• 
Woman of childbearing potential who is known to be pregnant on admission.  
• 
Any condition that in the judgment of the investigator could impose hazards to the patient if study 
therapy is initiated or affect the participation of the subject in the study.  
• 
Subject is Philips employee or their family members residing with this Philips employee. 
No. of subjects 
A total of 37 patients will be included in this feasibility study.   
 
Taking into account a 10% drop-out rate, it is expected by experts that a Per Protocol population of 33 
patients is to collect sufficient data for the evaluation of the primary and secondary objectives and to de-
risk the AirWaze features.  
 
Operators 
In the pre-procedural evaluation of the AirWaze software device, at least three users (n=3) (e.g. 
interventional pulmonologist experts) will be performing the pre-procedural planning of the CBCT guided 
peripheral pulmonary nodules biopsies. In the peri-procedural evaluation of the AirWaze software device, 
at least three certified bronchoscopists (n=3) (e.g. interventional pulmonologist experts) will be performing 
CBCT guided biopsies of peripheral pulmonary nodules biopsies. 
 
Study procedures 
Current clinical practice 
• 
Pre-procedural 
In current clinical practice, the lesion identification and trajectory planning are performed by interventional 
pulmonologists who need to mentally reconstruct the navigation trajectory (mind-map) based on the 
available CT-images in routine DICOM viewers.  
 
• 
Intra-procedural 
The procedure starts with an inspection bronchoscopy to examine the trachea and proximal airways. If the 
tumour is not visible endobronchially, navigation bronchoscopy is continued by advancing a pre-formed 
curvature catheter through the bronchoscope under image guidance. Advanced imaging with CBCT and AF 
will expedite catheter guidance through the airways. The CBCT gives feedback about the position of the 
catheter in a three-dimensional space. Once tool-in-lesion is confirmed with either radial-endobronchial 
ultrasound (rEBUS), rapid on-site evaluation (ROSE) and/or CBCT, tissue sampling is performed. If 
indicated, an EBUS is performed for staging lung cancer. 
 
Study practice 
• 
Pre-procedural 
In this study, pre-procedural planning will be performed with Philips’ AirWaze software. The CT-scan is 
loaded into the software system and the airways will be segmented and visualized. The target lesion is 
segmented with a one-click segmentation by the physician and is followed by a selection of the pathway to 
the target lesion.  
  
• 
Intra-procedural 
As performed routinely, an inspection bronchoscopy is performed at the start of the procedure. The selected 
pathway to the target lesion from the planning will be registered to and overlayed on the first performed 
CBCT. This overlay is visible at any time and will help the physician guide to the target lesion. If CBCT is 
indicated in conventional procedures, a low-dose CBCT-FluoroSweep (CBCT-FS) scan will be performed 
of the same catheter and tool position. The CBCT-FS has the same function as the regular CBCT, but it will 

 
IGT Systems 
Feasibility Clinical Investigation Protocol 
 
AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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be evaluated whether the low-dose CBCT-FS is as accurate as the CBCT. Once tool-in-lesion is confirmed 
with either rEBUS, ROSE and/or CBCT-FluoroSweep (with regular CBCT as gold standard), tissue sampling 
is performed. If indicated, an EBUS is performed for staging lung cancer. 
 
Follow-up 
Subjects are enrolled in the clinical investigation for the duration of the interventional procedure until 1 week 
post-procedure. A safety follow-up visit will take place at 1 week post-procedure.  
 
 
Duration of the study 
The total duration of the study is expected to take approximately 18 months, from the first patient to the last 
patient (excluding reporting). The first patient was enrolled in October 2023. 
 
 
 
 

 
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AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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3. 
Device Description 
3.1. 
Summary description of the investigational device 
The AirWaze Investigational Device (version 1.1) is developed by Philips Medical Systems, and hereinafter 
referred to as AirWaze. The investigational software device consists of five main features (Figure 1): 
 
1. Advanced planning software that supports bronchoscopists in optimally preparing the navigation 
bronchoscopy (NB) procedure by reconstructing the patient-specific airways, proposed navigation 
trajectory and target lesion in 3D from a pre-procedural CT scan; 
2. Augmented fluoroscopy based upon an intra-procedurally acquired CBCT that provides in-room 
image-guided, real-time navigation by augmenting the fluoroscopy imaging with an overlay of the 
airways, proposed navigation trajectory, and target lesion;   
3. Automatic device detection that visualizes the endobronchial catheter and lesion to support device-in-
lesion assessment; 
4. Directional guidance software that provides guidance for accurate device navigation, positioning, and 
tool-in-lesion confirmation;  
5. CBCT-FluoroSweep, a dedicated low dose radiation protocol, that supports pulmonologists in 
acquiring lower radiation dose tool-in-lesion confirmation scans instead of the conventionally 
performed CBCT scan.  
 
 
 
 
 
Figure 1. Software features of the AirWaze investigational device (version 1.1), namely advanced planning software (top 
left), augmented fluoroscopy (top middle), automatic device detection (top right), directional guidance software (bottom 
left), and CBCT-FS imaging protocols (bottom right). 
Advanced planning software
Augmented fluoroscopy
Automatic device detection
Directional guidance software
CBCT-FluoroSweep (low dose radiation protocol)

 
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AirWaze – easy and advanced tools for 
CBCT guided lung interventions 
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Table 1. Overview of the medical devices involved in the clinical study. 
 
# 
Device Name 
Manufacturer 
Regulatory Status 
1 
Philips Interventional X-ray 
System:  
Azurion 7 M20 FlexArm R2.1  
Philips Medical Systems Nederland B.V, 
Veenpluis 6, 
5684 PC, Best,  
The Netherlands 
EU: CE marked 
US: FDA 510(k) cleared 
Azurion R2.1: K200917 
 
2 
Interventional Workspot R1.6 
and future updates as 
required (workstation 
containing Interventional 
Tools software) 
Philips Medical Systems Nederland B.V, 
Veenpluis 6, 
5684 PC, Best,  
The Netherlands 
EU: CE marked 
US: FDA 510(k) cleared 
K181177 
 
 
3 
AirWaze Investigational 
Device (version 1.1) 
Philips Medical Systems Nederland B.V, 
Veenpluis 6,  
5684 PC, Best,  
The Netherlands 
 
Investigational device 
 
There is an Investigator Brochure, and Instructions for Use related to AirWaze [REF-1] and [REF-2], 
respectively. 
3.2. 
Intended Purpose 
 
For a more detailed description of the investigational device including safety precautions and handling, see 
the Instructions for Use (IFU) [REF-2]. 
3.2.1. 
Indications for Use/medical purpose 
 
Device Description 
AirWaze Investigational Device 1.1 : 
• 
is a post processing software medical device intended to assist physicians with lung interventions 
under X-ray guidance; 
• 
enables inspection of 3D reconstructions of the thorax, segmentation of airways and lesions, 
endobronchial path-planning and overlay of 3D reconstruction with correspondent planning 
information on live 2D fluoroscopic images; 
• 
provides real-time feedback on device position with respect to the planned path and ablation zone; 
• 
is based on the commercial Interventional Workstation 3DRA products.  
 
 
Indications for Use 
The AirWaze Investigational Device 1.1: 
• 
is intended as an adjunct means to help with the planning and guidance of lung procedures such as 
biopsy or ablation; 
• 
is intended to be suitable for patients with medical conditions such as where peripheral 
bronchoscopy is necessary, biopsy is considered a suitable diagnosis procedure, or ablation is 
considered a suitable therapy; 
• 
is a software medical device and does not interact directly with the patient. 
3.2.2. 
Intended Operator Profile 
The AirWaze Investigational Device 1.1 is intended to be used and operated by: adequately trained, qualified, 
and authorized health care professionals who have understanding of the safety information and emergency 
procedures as defined by local laws and regulations for radiation workers and staff. 
Operators are clinical specialists such as Interventional Pulmonologists, Thoracic Surgeons or Interventional 
Radiologists who are fully skilled and responsible for sound clinical judgment and for applying the best clinical 
procedure. The operator may also be an assisting HCP authorized by the physician. 

 
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3.2.3. 
Clinical Environment 
The AirWaze Investigational Device 1.1 is a fixed and stationary system that can be used in the control room 
and in the exam room of an interventional suite or operating room fulfilling the local laws and regulations for 
radiological X-Ray systems in sterile and non-sterile environments. The system is connected to a Philips 
Allura or Philips Azurion X-ray system. 
3.2.4. 
General Safety and Effectiveness 
To facilitate safe and efficacious operation of the system by a trained healthcare professional, instructions for 
use are provided as part of the device labelling, as well as training at system handover. 
3.2.5. 
Contraindications 
No specific contraindications were identified. 
3.2.6. 
Operating principle 
The system uses X-ray image processing for medical imaging. The control mechanisms are input devices 
and controls as mouse and keyboard in the control room and the TSM at the exam room. The system 
provides feedback by visual means. 
3.2.7. 
Necessary training and experience needed to use the investigational 
device  
The interventional pulmonologist and the technical team with experience in CBCT-guided navigation 
bronchoscopy will receive the necessary training to use the AirWaze investigational device. To facilitate safe 
and efficacious operation of the system by a trained healthcare professional(s), instructions for use are 
provided as part of the device labelling, as well as training at system handover. 
3.3. 
Materials that will be in contact with tissues or body fluids 
Not applicable. 
3.4. 
Device Traceability 
Traceability of the investigational device will be achieved during and after the clinical investigation by the 
following identification: 
 
Table 2. Identification. 
Investigational Device 
Identifier  
AirWaze Investigational Device 
(version 1.1) 
Will be identified by the AirWaze software archive identifier in 
combination with the related unique software revision number 
 
Records shall be kept to document when the investigational device is received, installed, returned, or 
uninstalled at the hospital. 
4. 
Justification for the design of the study 
4.1. 
State-of-the-art  
Lung cancer remains the leading cause of cancer-related deaths, counting 1.8 million cases worldwide in 2020 
and expects to rise in the upcoming years 1,2. Lung cancer has a high mortality, because of its often already 
metastatic disease at time of symptom presentation and diagnosis. Computed Tomography (CT) and Positron 
Emission Tomography (PET) are important imaging modalities in lung cancer diagnosis and show suspected 
pulmonary lesions as high-density or high-avidity, respectively. These imaging methods are useful, but 
pulmonary lesions with an intermediate to high risk of malignancy should preferably be diagnosed by image-
guided biopsy, such as surgical biopsy or CT-guided transthoracic needle aspiration (CT-TTNA). The latter is 
a minimally invasive approach that performs a percutaneous biopsy by advancing a needle under CT guidance. 

 
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Although CT-TTNA has a high sensitivity for malignancy (approximately 90%), complications such as 
pneumothorax (pooled complication rate 18.8-25.3%) and associated chest tube placement (6-7%) are 
relatively high because traversing the thoracic wall and pleura with a needle 3. 
 
Another technology with a well-accepted safety profile is navigation bronchoscopy (NB). This approach is a 
less invasive and less pneumothorax-inducing technique (pooled complication rate 1.5%, requiring chest tube 
placement in only 0.6%) using the airways for navigation4. Several technological innovations have been 
developed for endobronchial navigation to pulmonary lesions. Bronchoscopy combined with electromagnetic 
navigation bronchoscopy (ENB), virtual bronchoscopy navigation or robotic assisted bronchoscopy (RAB) all 
achieve good results for navigation, but a second imaging modality is needed for positioning of the catheter 
and tool-in-lesion confirmation 5–7. For instance, radial endobronchial ultrasound (rEBUS), fluoroscopy and/or 
cone-beam CT (CBCT) can provide catheter positioning confirmation.  
 
• 
ENB is a minimally invasive, image-guided approach to access lung lesions for biopsy. The 
NAVIGATE trial evaluated ENB safety and diagnostic yield in a multi-centre cohort study. A recent 
update of the NAVIGATE trial reported a diagnostic yield of 67.8% overall and 62% for nodules smaller 
than 20 mm. The reported overall complication rate for pneumothorax is 4.7%, and 3.2% require 
intervention or hospitalisation8. In conclusion, ENB procedures have been proven to have low 
complication rates, however, the diagnostic yield cannot compete with the diagnostic yield of CT-
TTNA. 
 
• 
RAB is a technology that has gained much attention since the introduction of the first system in the 
US in 2018. Nowadays, there are two systems available in the US market: Auris Monarch and Intuitive 
Ion. The diagnostic yield of these systems varies between 69.1 and 81.7%, respectively, and have 
demonstrated low complication rates for pneumothoraxes 5,9. 
 
• 
The diagnostic yield increases even more, when CBCT and augmented fluoroscopy (AF) are 
involved in navigation bronchoscopy. Pritchett et al. Used ENB in combination with CBCT and AF to 
guide to the lesions. This resulted in a navigation success of over 83% for both small and large lesions 
10. Verhoeven et al. Reported a diagnostic yield of 90.6% after experiencing the effect of a learning 
curve 11. As additional guidance and confirmation method, r-EBUS was used. In conclusion, utilizing 
intraprocedural CBCT image guidance—a relatively new technique in interventional pulmonology 
field—may retain complication risk while further increasing the accuracy (83.7 – 90.6%) of this 
technology-enhanced navigation bronchoscopy procedure. Aside from its unique ability to acquire 
intraprocedural three-dimensional (3D) information, deemed valuable for meticulous positioning of 
tools, the CBCT system can also augment a navigation pathway and lesion position as an overlay on 
two-dimensional (2D) ﬂuoroscopic imaging. With this unique combination of features, CBCT has the 
potential to meticulously help guide the endoscopist during the different aspects of the procedure. 
CBCT-guided NB can provide 3D positioning confirmation and has a diagnostic accuracy of 90% for 
peripheral pulmonary nodules.  
 
Unfortunately, CBCT-guided NB has a significant learning curve, mainly because of the high cognitive load for 
the bronchoscopist 11. Cognitive load is the overall effort expended by individuals in response to a task and is 
closely related to the usability of devices for medical procedures. A high cognitive load is associated with poor 
surgical outcomes and represents a bottleneck for learning that directly affects performance and acquisition of 
competency12. In CBCT navigations, the bronchoscopist must mentally reconstruct the patient-specific 
anatomy including the airways, relevant vasculature, and the lesion, which requires a high cognitive load. This 
3D visualization of the bronchial tree and the translation into the rotational catheter progression using AF 
overlays in different directions increases the cognitive load more and more. This cognitive load diminishes the 
widespread implementation of this technique. Therefore, there is a need for imaging assistance with easy and 
advanced software tools for CBCT-guided navigation bronchoscopy.  
 

 
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4.2. 
Evaluation of (pre)clinical testing 
The 3D segmentation of the endobronchial tree based on pre-procedural CT, lesion segmentation, and 
pathway generation with the AirWaze investigational device (version 1.0) have been evaluated in a preclinical 
setting. Here, the first-pass navigation success was between 73 and 79% and was 100% in a second pass 
and overall. Fluoroscopy times were in clinically relevant timeframes. Navigation error, which is defined as the 
distance from the catheter tip to the bifurcation measured on the confirmatory CBCT, was another important 
endpoint. These errors were 2.2 ± 1.2 mm ex vivo and 4.9 ± 3.2 mm in vivo and are more accurate than results 
reported with ENB. In conclusion, endobronchial navigation was assessed as feasible and accurate with CBCT 
and AF guidance in both ex vivo and in vivo models 13. 
 
In a clinical feasibility study, the AirWaze investigational device (version 1.0) was used to plan and guide the 
navigation procedure with CBCT and augmented fluoroscopy of the target lesion, pathway and bronchial tree 
(Figure 2) 14. A total of 52 subjects and 59 lesions with an average median lesion size of 19.0 mm (range 7-48 
mm) were included in this study. The navigation success was 98.3% and the overall diagnostic yield was 
91.4% (91.2% for lesions <20 mm). No severe adverse events related to CBCT NB with the AirWaze 
investigational device (version 1.0), such as pneumothorax, respiratory failure, were observed. These results 
are comparable with findings from the same clinical center using a combination of ENB and CBCT with AF of 
the target lesion for navigation bronchoscopy. These results demonstrate the safety of CBCT and AF guided 
biopsies of peripheral pulmonary lesions with the AirWaze investigational device (version 1.0) to obtain high 
diagnostic yields. 
 
Figure 2. CBCT guidance in bronchoscopy with advanced software tools for peri-procedural planning and 3D image-
guidance (AirWaze investigational device, version 1.0). After 3D segmentation of the target lesion and the 
bronchial tree on pre-operative CT data, the virtual pathway to the target nodule was generated (A-D). 
Automatic elastic registration of the pre-operative CT with intraprocedural CBCT data enabled live guidance 
with augmented fluoroscopy views of the airways and virtual pathway to the segmented target lesion I. 
Confirmation of tool-in-lesion (F). 
 
 

 
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4.3. 
Evaluation of clinical data  
The AirWaze software tools enable the physician to plan, guide and confirm during navigation bronchoscopy 
of peripheral pulmonary nodules.  
 
Background clinical application 
This study is for subjects with peripheral pulmonary lesions suspicious of malignancy. Traditionally, there are 
three pathways for lung lesion diagnosis: (i) watchful waiting with CT follow-up, (ii) minimally invasive 
diagnostic techniques, and (iii) surgical excision with diagnostic analysis. There are two ways to obtain 
minimally invasive tissue diagnosis, namely via CT-guided TTNA and navigation bronchoscopy (Section 4.1). 
CBCT-guided navigation bronchoscopy combines navigation guidance with 3D-image confirmation of tool-in-
lesion positioning. It can help guide and verify sampling in 3D in near real-time. CBCT-guided NB has proven 
to have a lower complication rate compared to CT-TTNA while maintaining diagnostic accuracy. However, 
disadvantages of CBCT-guided NB are the high cognitive load during planning and procedure, and the inherent 
use of radiation.  
 
The AirWaze Investigational Device (version 1.1) with an improved user interface compared to version 1.0 has 
been designed to reduce the cognitive load before- and during CBCT-guided NB, and therewith improve overall 
navigation bronchoscopy procedure accuracy. Furthermore, dedicated low dose imaging protocols have been 
designed to reduce the radiation dose of intraprocedural 3D imaging (i.e. CBCT-FluoroSweep). The improved 
ease-of-use, reduced cognitive load and tailored radiation protocols for CBCT-guided interventions are 
anticipated to increase the overall accuracy of the procedure and help implement it in routine clinical practice 
across institutes fuel the adoption of CBCT-guided NB. 
 
 
 
 

 
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5. 
Risks and benefits of the investigational device and feasibility 
clinical investigation 
The risk assessment process that Philips follows is in accordance with ISO14971. This will ensure that the 
level of risk is acceptable prior to the start of the clinical feasibility study. 
 
Benefits 
Benefits related to the investigational device compared to state-of-the-art devices are an improved ease-of-
use and a reduced cognitive load for the physicians during CBCT-guided navigation bronchoscopy, while 
maintaining patient safety and a high diagnostic accuracy for peripheral pulmonary nodules.  
 
Future patient benefit (= after clinical feasibility study of CBCT-FS): 3D confirmation of tool-in-lesion with 
CBCT-FS may result in less radiation dose compared to conventional CBCT and augmented fluoroscopy 
 
There is a possibility that the patient may not benefit from participating in the study. 
 
Risks 
Risks related to the AirWaze investigational device 1.1 compared to state-of-the-art devices, the standard of 
care/procedure, is: 
 
• 
As the novel AirWaze software will be evaluated by combining a CBCT with immediate FluoroSweep 
afterwards (with the intention that they will both give similar image information), radiation dose will be 
increased for staff and patient. The additional fluoroscopy level dose will have a minimal impact on the 
overall procedure and staff dose. 
• 
Based on incorrect anatomical overlay information, the operator might deploy the catheter/biopsy tool 
inaccurately. Possible harm is: 
o 
Bronchial hemorrhage (E0707) 
o 
Pneumothorax (E0734) 
o 
Procedure related complications (E21) 
o 
Delay to treatment/therapy (F05) 
 
The risks of participating in the clinical feasibility study with the AirWaze investigational device are illustrated 
in Table 3. All risks have been reduced as far as possible and individual residual risks after mitigation are all 
classified as acceptable, marked by the green zone in Table 3. No additional risks were identified when verifying 
the risk mitigation. 
 
Anticipated adverse device effects are listed in section 15.3 Anticipated adverse device effects (including the 
steps that are taken to control or mitigate the risks). 
 
Table 3. Overview of the residual risk profile of the investigational device. 
Count of Residual Severity 
Delta Residual Severity* 
Residual Probability of Harm 
(PoH) occurrence** 
S0 
S1 
S2 
S3 
S4 
PoH 5 
≥ 10 000 
0 
0 
0 
0 
0 
PoH 4 
1 000 - <10 000 
0 
0 
0 
0 
0 
PoH 3 
100 - <1 000 
0 
0 
0 
0 
0 
PoH 2 
10 - <100 
2 
1 
6 
0 
0 
PoH 1 
<10 
0 
0 
0 
0 
0 
Grand Total 
2 
1 
6 
0 
0 
*Severity is defined according to: 
S0 – Negligible: Results in Inconvenience or temporary discomfort not requiring professional medical 
intervention OR in customer dissatisfaction where there is no injury. 
S1 – Minor: Results in injury or temporary impairment not requiring professional medical intervention 
S2 – Major: Results in injury or temporary impairment requiring professional medical intervention 

 
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S3 – Critical: Results in permanent impairment OR in an injury, which is life-threatening if professional medical 
intervention is not obtained 
S4 – Catastrophic: Directly results in death 
 
** Probability is defined as likelihood per 1000000 examinations 
PoH–5 – Occurs ‘every time’ (≥10 000 per 1000000). 
PoH–4 – Good chance to occur; considerable certainty to occur (1 000— <10 000 per 1000000). 
PoH–3 – Expected to occur from time to time; rarely occurring (100—<1 000 per 1000000). 
PoH–2 – Not expected to occur (10— <100 per 1000000). 
PoH 1 – Improbable (<10 per 1000000). 
 
There are no possible interactions with concomitant medical treatments. 
5.1. 
Benefit-to Risk rationale 
The outcome of the risk management process for the clinical study including the use of the investigational 
device is that the medical benefits of the device outweigh the risks associated with its use.  
 
There is no unacceptable risk when participating in the clinical study with the AirWaze investigational device. 
The residual risks for the investigational device use are low and therefore outweighed by the medical benefits 
as outlined above. The investigational device can be safely used in clinical practice. 
 
6. 
Objectives  
6.1. 
Primary objective  
The primary objectives of this feasibility clinical investigation are to assess the overall system usability of the 
Philips AirWaze investigational device as measured by the System Usability Score (SUS) and the accuracy of 
the tool-in-lesion confirmation scan CBCT-FluoroSweep compared to the conventional CBCT.  
 
6.2. 
Secondary objective(s) 
The secondary objectives of this clinical feasibility investigation are: 
 
- 
To assess intuitiveness of the individual AirWaze features by the physicians. 
- 
To assess performance the following developed algorithms: 
(a) Segmentation bronchial tree on pre-procedural CT. 
(b) Elastic registration of the intraoperative CBCT scans with preprocedural CT scan.  
(c) Automatic device detection on intraoperative CBCT scans. 
- 
To assess the quality of the interventional plan (pre-procedural planning). 
- 
To assess the confidence levels of interventional pulmonologists while using AirWaze (pre-
procedural planning). 
- 
To assess the intraprocedural cognitive load of CBCT-guided NB.  
- 
To determine the radiation exposure for patients and staff. 
- 
Report all adverse events, adverse device effects and device deficiencies.  
 
 

 
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7. 
Study Design 
7.1. 
General 
The AirWaze software tools for CBCT-guided diagnosis of peripheral pulmonary nodules will be studied at the 
Radboud University Medical Centre with the Principal Investigator described below: 
 
Name Principal Investigator(s) 
Name and address investigation site(s) 
 
Erik H.F.M. van der Heijden, MD, PhD 
Professor of Interventional Pulmonology 
 
 
Radboud University Medical Center Nijmegen 
Department of Pulmonary Diseases 
6500 HB Nijmegen, The Netherlands 
 
 
An interview guide will be used to collect data regarding the primary endpoint. Data about the primary endpoints 
will be collected with semi-structured interviews as described in Appendix I: System Usability Scale (SUS) and 
Appendix II: CBCT-FS compared to CBCT.  
 
A total of 37 prospectively included subjects in the Intention-To-Treat population are necessary to collect 
sufficient data for the evaluation of the objectives of this clinical investigation. After applying a drop-out rate of 
10% of subjects will be lost, a total of 33 subjects in the Per Protocol population is required. More information 
on the statistical considerations can be found in Section 8. 
 
7.1.1. 
Endpoints 
The primary and secondary endpoints are based on the objectives (Section 6) and are described below. 
 
 
Primary endpoints 
The system usability will be assessed by using the System Usability Scale (SUS) 15. An average SUS of greater 
than 70 will indicate a good usability design of the AirWaze Software solution. The SUS will be measured per 
operator every 4 procedures.   
 
Image-based tool-in-lesion confirmation accuracy of CBCT-FS is defined as the number of procedures where 
CBCT-FS scans were adequate to define tool-in-lesion compared to conventional CBCT scans (gold-
standard). The image-based tool-in-lesion accuracy is defined as the sum of the number of tool-in-lesion in 
both the CBCT-FS and CBCT images (i.e. true positives), and the number of no tool-in-lesion confirmation in 
both the CBCT-FS and CBCT images (i.e. true negatives), divided by the total number of CBCT-FS and CBCT 
pairs. Image based tool-in-lesion confirmation accuracy of 90% will indicate that the CBCT-FS is postulated to 
be sufficient for navigation bronchoscopy. 
 
 
 

 
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Secondary endpoints 
 
The secondary endpoints of this feasibility clinical investigation are: 
 
- 
Semi-structured questionnaires to assess intuitiveness of AirWaze features for CBCT-guided biopsy 
of peripheral pulmonary nodules (Appendix III). 
- 
Quantitative and qualitative assessment of the developed algorithms is assessed through a 
questionnaire (Appendix IV). 
(a) Segmentation bronchial tree on pre-procedural CT. 
(b) Elastic registration of the intraoperative CBCT scans with preprocedural CT scan.  
(c) Automatic device detection on intraoperative CBCT scans. 
- 
The quality of the interventional planning is defined by comparing the pre-procedural planned 
navigation trajectory compared to the actual navigation trajectory towards the first lesion (Appendix 
V). 
- 
Confidence levels of pulmonologists are defined as a score (0-10) to examine the degree of confidence 
of specialists regarding: (i) the localization of the lesion and planned navigation trajectory; (ii) reaching 
the first pulmonary lesion based on the planning (Appendix V). 
- 
The cognitive load of pulmonologists during the navigation towards the first lesion will be measured 
with the Surgical Task Load Index (SURG-TLX) which is a validated method for measuring cognitive 
load. The questionnaire is asked after tool-in-lesion confirmation (either rEBUS, CBCT, or CBCT-FS) 
12,16,17 (Appendix V). 
- 
Radiation exposure for patients will be measured in effective dose (mSv) and DAP (Gy·cm2) per 
procedure including fluoroscopy, CBCT and CBCT-FS radiation dose. The fluoroscopy time 
(minutes) will be measured as well (Appendix V). 
- 
Radiation exposure for the staff is measured in an average scattered effective dose (mSv) per 
procedure at hand and chest (Appendix V).  
- 
Report 
all 
adverse 
events 
(including 
but 
not 
limited 
to 
pneumonia, 
pneumothorax, 
bleeding/hemorrhage). 
- 
Report all adverse device effects.  
- 
Report all device deficiencies. Device deficiencies that could have led to an SAE need to be reported 
in the Clinical Study End Report. 
 
7.1.2. 
Maintenance and calibration 
The equipment relevant for the assessment of the clinical investigation is the Philips Azurion C-arm system. 
Maintenance and calibration of this equipment will be monitored if this is appropriately performed and 
documented. 
 
7.1.3. 
Operators / users 
In the pre-procedural evaluation of the AirWaze software device, at least three users (n=3) (e.g. interventional 
pulmonologist experts) will be performing the pre-procedural planning of the CBCT guided peripheral 
pulmonary nodules biopsies. In the peri-procedural evaluation of the AirWaze software device, at least three 
certified bronchoscopists (n=3) (e.g. interventional pulmonologist experts) will be performing CBCT guided 
biopsies of peripheral pulmonary nodules biopsies. 
7.2. 
Investigational device exposure and comparators 
During this study, a single investigational device (the AirWaze software device) will be used in this clinical trial, 
from the Philips workstation connected to the Philips Azurion. The AirWaze device will be used for procedural 
planning, image-guided navigation, and tool-in-lesion confirmation for bronchoscopic biopsy. 

 
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7.3. 
Subjects  
7.3.1. 
Inclusion and exclusion criteria 
In- and exclusion criteria ensure the inclusion of subjects within the intended patient population of the 
investigational device. 
7.3.1.1. 
Inclusion criteria 
In order to be eligible to participate in this study, a subject must meet the following criteria:  
• 
Age 18 years or older at the time of informed consent. 
• 
ASA physical status between 1 and 3. 
• 
Subject is willing and able to give written informed consent for clinical investigation participation prior 
to the procedure. 
• 
Subject has a pulmonary lesion (e.g. a focal rounded opacity mostly surrounded by aerated lung or a 
ground glass opacity or part- or (sub)solid lesion) with an indication for diagnostic evaluation following 
current clinical guidelines and/or as decided by multi-disciplinary team consultation. 
• 
Suitable for CBCT-guided endobronchial nodule biopsy under general anaesthesia. 
• 
Pre-procedural (PET-)CT scan is immediately available prior to procedure.  
 
7.3.1.2. 
Exclusion criteria 
A potential subject who meets any of the following criteria will be excluded from participation in this study: 
• 
Aged 17 or younger at the time of informed consent.  
• 
ASA physical status is equal to and greater than 4.  
• 
Not willing or not able to give informed consent.  
• 
Does not indicate diagnostic evaluation with navigation bronchoscopy.  
• 
Not suitable for CBCT-guided endobronchial nodule biopsy via navigation bronchoscopy under 
general anaesthesia.  
• 
There is no recent pre-procedural (PET-)CT scan available.  
• 
Known bleeding disorders. 
• 
Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, 
warfarin, therapeutic dose of low molecular weight heparins, clopidogrel or analogues, NOACs). 
• 
Known allergy for lidocaine or other allergies interfering with the procedure. 
• 
Uncontrolled pulmonary hypertension. 
• 
Recent and/or uncontrolled cardiac disease. 
• 
Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any 
reason such that endobronchial access is considered unsafe). 
• 
Potentially confounding drug or device trial clinical study. Co-enrollment in concurrent trials may be 
allowed if pre-approval is obtained from Philips Clinical Study Manager. 
• 
All vulnerable subjects, such as immune-compromised subjects, subjects lacking the capacity to 
provide consent, patients in emergencies, pregnant or breastfeeding women, or any other subject who 
meets exclusion criteria, according to applicable national laws, if any. 
• 
Woman of childbearing potential who is known to be pregnant on admission.  
• 
Any condition that in the judgment of the investigator could impose hazards to the patient if study 
therapy is initiated or affect the participation of the subject in the study.  
• 
Subject is Philips employee or their family members residing with this Philips employee. 
7.3.2. 
Enrollment and duration 
The total duration of the study is expected to take approximately 18 months, from the first patient to the last 
patient (excluding reporting). The first patient was enrolled in October 2023.  
 
• 
Subjects are enrolled in the feasibility clinical investigation after they have signed the informed consent 
form. No study procedures will be performed before this moment.  

 
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• 
Subjects are enrolled in the clinical investigation for the duration of the interventional procedure until 
1 week post-procedure. A safety follow-up visit (either by phone or clinic visit) will take place at 1 week 
(-2 days/+7 days) post procedure.  
 
The clinical investigation is completed when the last subject has undergone CBCT-guided NB and follow-up 
visit, whether the clinical investigation concluded according to the pre-specified clinical investigation plan or 
was terminated prematurely.  
7.3.3. 
Number of subjects 
A total of 37 prospectively included subjects in the Intention-To-Treat population are necessary to collect 
sufficient data for the evaluation of the primary and secondary objectives of this clinical investigation. After 
applying a drop-out rate of 10% of subjects will be lost, a total of 33 subjects in the Per Protocol population is 
required. More information on the statistical considerations can be found in Section 8. 
 
7.3.4. 
Procedure for the replacement of subjects  
Subjects in the study will be replaced in case of withdrawal of consent or the subject is found illegible for the 
study after signing the informed consent and before the procedure. The data of these subjects will not be 
analyzed (per protocol analysis, see section “statistical considerations”).  
 
7.3.5. 
Subject withdrawal  
Subjects can withdraw informed consent at any time for any reason during the clinical investigation. The 
investigator can decide to withdraw a subject from the study for urgent medical reasons. Normal clinical 
standard of care will be followed to obtain a diagnosis.  
7.4. 
Procedures 
The flowchart for current clinical practice and study practice CBCT-guided navigation bronchoscopy are 
depicted in Figure 3 below.  
 
Current clinical practice 
• 
Pre-procedural 
In current clinical practice, the lesion identification and trajectory planning are performed by interventional 
pulmonologists who need to mentally reconstruct the navigation trajectory (mind-map) based on the available 
CT-images in routine DICOM viewers.  
 
• 
Intra-procedural 
The procedure starts with an inspection bronchoscopy to examine the trachea and proximal airways. If the 
tumour is not visible endobronchially, navigation bronchoscopy is continued by advancing a pre-formed 
curvature catheter through the bronchoscope under image guidance. Advanced imaging with CBCT and AF 
will expedite catheter guidance through the airways. The CBCT gives feedback about the position of the 
catheter in a three-dimensional space. Once tool-in-lesion is confirmed with either rEBUS, rapid on-site 
evaluation (ROSE) and/or CBCT, tissue sampling is performed. If indicated, an EBUS is performed for staging 
lung cancer. 
 
Study practice 
• 
Pre-procedural 
In this study, pre-procedural planning will be performed with Philips’ AirWaze software. The CT-scan is loaded 
into the software system and the airways will be segmented and visualized. The target lesion is segmented 
with a one-click segmentation by the physician and is followed by a selection of the pathway to the target 
lesion.  
  

 
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• 
Intra-procedural 
As performed routinely, an inspection bronchoscopy is performed at the start of the procedure. The selected 
pathway to the target lesion from the planning will be registered to and overlayed on the first performed CBCT. 
This overlay is visible at any time and will help the physician guide to the target lesion. If CBCT is indicated in 
conventional procedures, a low-dose CBCT-FluoroSweep scan will be performed of the same catheter and 
tool position. The CBCT-FluoroSweep has the same function as the regular CBCT, but it will be evaluated 
whether the low-dose CBCT-FluoroSweep is as accurate as the CBCT. Once tool-in-lesion is confirmed with 
either rEBUS, ROSE and/or CBCT-FluoroSweep (with regular CBCT as gold standard), tissue sampling is 
performed. If indicated, an EBUS is performed for staging lung cancer. 
Follow-up 
Safety follow-up visit will take place 1 week post-procedure (+7 days / -2 days). This visit may occur via phone 
or clinic visit. All adverse events that have occurred until this visit will be collected and monitored, including 
any prolonged hospital stay because of procedural complications, as well as unexpected complications. 
  
 
Figure 3. Flowchart of the CBCT-guided navigation bronchoscopy procedure of the current clinical practice 
(bottom flow) and study practice with the AirWaze investigational device (top flow).  
*Will be excluded from the PP population, see section 8.1. 
7.5. 
Monitoring Plan 
Monitoring will be performed by a trained person appointed by Philips to ensure compliance with the feasibility 
clinical investigation protocol, applicable national regulations and international standards, patient safety and 
data validity. The Sponsor may designate one or more individuals to monitor the progress of a clinical study. 
The Sponsor may also delegate the monitoring responsibilities to a third party. However, the Sponsor remains 
ultimately responsible for the conduct of the study. The Institution is responsible for the appropriate de-
identification of subject data. The investigational site should provide access to the source data of the subjects. 
 
The first visit will occur as soon as possible after the first subject is enrolled at each study site. The monitoring 
schedule is based on the following considerations: enrollment rate, study compliance at the center, the 
magnitude of data corrections required, the complexity of the feasibility clinical investigation, IRB/MEC request, 
and audit/inspection.  
 
The monitor activities include: 

 
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• 
Check that the study is conducted, recorded and reported in compliance with the clinical protocol, good 
clinical practice, and applicable regulations. Acts to oversee the progress of the study. 
• 
Check signed and dated informed consent of the subjects and check that this is signed before any 
study-related procedures are undertaken. 
• 
Ensure that essential documents (e.g., legal contract, MEC/IRB approval) are maintained in the Site 
Regulatory File. 
• 
Ensure recording of deviations from protocol and store in Site Regulatory File or e-CRF. 
• 
Ensure that all adverse events and device deficiencies are reported to the sponsor, and all serious 
adverse events and device deficiencies that could have led to a serious adverse device effect are 
reported to the sponsor without unjustified delay. 
• 
Ensure that applicable adverse event and device deficiency are reported to the MEC/IRB and 
Competent Authority (if applicable) within the required timeframe. 
• 
Ensure that the principal investigator is informed and knowledgeable of all relevant document updates 
concerning the feasibility clinical investigation (e.g., feasibility clinical investigation protocol and 
Investigator Brochure). Ensure that substantial amendments to the protocol and/or Investigators 
Brochure are submitted to the MEC/IRB and/or Competent Authority (if applicable) if required by the 
national regulations.  
• 
Ensure device accountability. 
 
Critical data and processes will be monitored for this study prior to clinical report completion based on a 
selective monitoring approach. The monitor activity solely involves the review of critical clinical data that effect 
study endpoints. Data collection for reasons other than to support the protocol-defined endpoints will not be 
monitored. A site close-out visit will be conducted once the site has completed collecting data for the study. 
 
Details of the monitoring approach and names of the involved monitor(s) will be laid down in the Monitoring 
Plan.  
8. 
Statistical considerations 
8.1. 
Analysis Populations 
The following analysis populations will be defined in this study:  
 
Enrolled Population  
The enrolled population is defined as all subjects who signed informed consent during the study.  
 
Intention-to-treat Population  
The intention-to-treat population (ITT) is defined as all subjects in the Enrolled Population that have undergone 
the CBCT-guided navigation bronchoscopy procedure as depicted in Figure 3 because suspected pulmonary 
lesions with intermediate to high risk of malignancy in early-stage disease were found on pre-procedural CT 
scans.  
 
Per Protocol population 
The Per Protocol population (PP) is defined as all ITT subjects without major protocol deviations. Protocol 
deviations will be divided into major protocol and minor protocol deviations. A major protocol deviation is one 
that may impact subject safety, affect the integrity of study data and/or affect subject's willingness to remain in 
the study. An example of a major violation is enrolling a participant who did not meet all the inclusion/exclusion 
criteria or failing to obtain or document informed consent prior to initiation of study procedures. Major protocol 
deviations would exclude the subject from the PP population.  
Minor protocol deviations are those that are not considered to significantly affect the primary endpoint analysis 
and hence do not warrant subjects’ exclusion from the PP population.  
Subjects with a tumor location endobronchial found during the inspection bronchoscopy and therefore not 
require the CBCT-guided navigation bronchoscopy (as displayed in Figure 3), will be excluded from the PP 
population. 
The PP population will be the primary population for the analyses as described in study objectives and 
endpoints. 

 
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8.2. 
Sample Size Justification 
A total of 37 patients will be included in this feasibility study. The physicians are familiar with the AirWaze 
investigational device in a non-clinical setting. The clinical setting will function as clinical and technical de-
risking of the software program and the information from this study will be used to design a robust pivotal claim-
driven study. Semi-structured questionnaires will be used to assess the overall system usability and the 
accuracy of the AirWaze CBCT-FS scan. Furthermore, the number of imaging and algorithm failures and the 
ability to work around quickly will be evaluated. Taking into account a 10% drop-out rate, it is expected by 
experts that a Per Protocol population of 33 patients is sufficient to de-risk the AirWaze features.  
 
 
8.3. 
General Consideration 
All results will be summarized using the following descriptive statistics: n, mean with 95% confidence interval 
(CI), standard deviation (SD), median, interquartile range (IQR), minimum and maximum. Categorical data will 
be summarized as the number and percentage of subjects in each category (including the category ‘missing’ 
if applicable). Generally, percentages will be calculated for missing categories and all percentages will be 
based on the total number of subjects in the population (denoted by N on the summary tables and figures) 
Statistical analysis will be performed using SAS (SAS® Life Science Analytics Framework) and/or R statistical 
software (https://www.r-project.org/).  
 
All data will be listed for the enrolled population. The data will be sorted by subject number.  
 
For summary statistics, the mean and median will be displayed to one decimal place greater than the original 
value and the measure of variability (e.g., SD) will be displayed to two decimal places greater than the original 
value. Minimum and maximum will be reported to the same decimal places as the original value. Percentages 
will be displayed in 1 decimal place. P-values will be reported to three decimal places; p-values less than 0.001 
will be reported as p<0.001. 
 
8.4. 
Subject Disposition 
Subject disposition, including the total number of subjects evaluated, will be presented. In addition, a listing 
will be provided with the reasons why the subject was not evaluated. 
8.5. 
Demographics and Baseline Characteristics 
Demographics Subjects  
Information on age (years), height (cm), and body mass index (BMI) (kg/m2) will be reported and summarized 
as continuous data. Gender (male, female, other), and comorbidities will be reported as categorical data. 
 
Demographics Operators 
The experience as a medical specialist (years), and the number of CBCT-guided bronchoscopy procedures 
performed (n) will be reported and summarized as continuous data.  
 
Baseline Subject Characteristics  
Lesion size (mm, long axial axis), and volume (mm3), will be reported and summarized as continuous data 
(mean ±SD). Location (lobe; LUL, LLL, RUL, RML, RLL), nodule aspect (solid, sub-solid, ground glass opacity, 
cystic), PET FDG avidity (no uptake, faint, moderate, intense) will be reported as categorical data. Overall 
ROSE pathology outcome at index procedure will be divided into benign, malignant, atypical cells (non-
diagnostic) and not representative biopsy samples.  
  

 
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8.6. 
Primary objective 
Objective 
The primary objectives of this feasibility clinical investigation are to assess the overall system usability of the 
Philips AirWaze investigational device (version 1.1) as measured by the System Usability Score (SUS) and 
the accuracy of the tool-in-lesion confirmation scan CBCT-FluoroSweep compared to the conventional CBCT. 
 
Primary Endpoints  
The system usability will be assessed by using the System Usability Scale (SUS)15. An average SUS of greater 
than 70 will indicate a good usability design of the AirWaze Software solution. The SUS will be measured per 
operator every 4 procedures that they have operated the AirWaze software solution.  
 
Image-based tool-in-lesion confirmation accuracy of CBCT-FS is defined as the number of procedures where 
CBCT-FS scans were adequate to define tool-in-lesion compared to conventional CBCT scans (gold-
standard). The accuracy is defined as the sum of the number of tool-in-lesion in both CBCT-FS and CBCT, 
and the number of no tool-in-lesion confirmation in both CBCT-FS and CBCT, divided by the total number of 
CBCT-FS and CBCT pairs. Image based tool-in-lesion confirmation accuracy of 90% will indicate that the 
CBCT-FS is postulated to be sufficient for navigation bronchoscopy.  
   
Analysis 
The results will be analyzed by using the average SUS and the SUS score development in time. No statistical 
test will be performed on the SUS scores due to limited data points. A SUS greater than 70 will indicate a good 
usability design of the AirWaze software device. More information on the SUS questionnaire can be found in 
Appendix I: System Usability Scale (SUS). 
 
The results will be analyzed by calculating the overall accuracy of the CBCT-FS for tool-in-lesion confirmation. 
More information on the CBCT-FS scan questions can be found in Appendix II: CBCT-FS compared to CBCT. 
An additional analysis will be performed within the tool-in-lesion confirmation group. Tool-in-lesion scans are 
evaluated and subdivided into center-strike and off-center confirmation scans18, subsequently the accuracy is 
calculated.  
 
8.7. 
Secondary objectives 
The secondary objectives are descriptive with no performance requirements and no sample size has been 
calculated. 
8.7.1. 
Secondary objective: Intuitiveness of AirWaze Features 
Objective 
To assess intuitiveness of the individual AirWaze features by the physicians. 
 
Endpoint 
Semi-structured questionnaire to assess intuitiveness of AirWaze features for CBCT-guided biopsy of 
peripheral pulmonary nodules.  
 
Analysis 
The results will be analysed by using the average intuitiveness scores per feature and the intuitiveness score 
development in time per feature. The intuitiveness of the AirWaze features is indicated as sufficient when the 
average score per AirWaze feature equals or is higher than 4 (= agree). No statistical test will be performed 
due to limited data points. More information on the intuitiveness questionnaire can be found in Appendix III: 
Semi-structured Questionnaires – Assessment of the intuitiveness of AirWaze features. 

 
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8.7.2. 
Secondary objective: Quantitative and qualitative assessment of developed 
algorithms 
Objective 
The objective is to assess the performance of the developed AirWaze algorithms. These algorithms are: (i) the 
segmentation of the bronchial tree based on the pre-procedural CT; (ii) the elastic registration of the pre-
procedural CT scan (including segmentations) to the intraoperative CBCT scan(s), and (iii) the automatic 
device detection on the intraoperative CBCT scans.  
Endpoint 
Quantitative and qualitative assessment of developed algorithms endpoints: 
• 
The quality of the segmented bronchial tree is defined on a 5-point Likert scale. The segmentation of 
the bronchial tree is rated independently from the location of the lesion. The segmentation is rated with 
a Likert score 1 = only trachea, right/left main bronchus, and bronchus intermedius are segmented, to, 
Likert score 5 = Bronchioles on a distance < 2 cm from the pleura are segmented.  
• 
The quality of the image registration is defined on a 5-point Likert scale from 1 (bad) to 5 (excellent). 
The image registration is bad if the registration around the target of interest shows large errors. The 
image registration is excellent if the images are registered accurately around the target of interest.  
• 
The quality of the automatic device detection is defined on a 5-point Likert scale from 1 (bad) to 5 
(excellent). The automatic device detection is poor if the device is barely or wrongly detected. The 
automatic device detection is excellent if the device is detected completely. 
• 
Algorithm failures are defined as the percentage of algorithm failures and the ability to quickly 
correct/work around them related to 1) segmentation of bronchial tree on preoperative CT scan, 2) 
image registration of the preoperative CT scan to the intraoperative CBCT and/or CBCT-FS scans or 
between CBCT(-FS) scans and 3) automatic catheter detection on both CBCT and CBCT-FS. 
Analysis 
The objective related to the clinical and technical feasibility of CBCT-FS will be evaluated by calculating:  
• 
Quality of the segmented bronchial tree is considered sufficient when the average Likert score equals 
or is higher than 4. For this categorical variable, counts and percentages will be calculated as well.  
• 
Quality of the image registration is considered sufficient when the average Likert score equals or is 
higher than 4. For this categorical variable, counts and percentages will be calculated as well. 
• 
Quality of the automatic device detection is considered sufficient when the average Likert score equals 
or is higher than 4. For this categorical variable, counts and percentages will be calculated as well. 
• 
Algorithm failures are acceptable when in <5 % of the cases for pulmonary lesions algorithm failures 
related to CBCT or CBCT-FS occurred.  
 
8.7.3. 
Secondary objective: Quality of the Interventional plan 
 
Objective 
To determine the quality of the interventional plan (pre-procedural planning).  
 
Endpoint 
The quality of the pre-procedural plan will be determined by comparing the pre-procedural planned navigation 
trajectory with the actual navigation trajectory towards the first lesion. 
 

 
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Analysis 
The objective will be expressed in the percentage of performed navigation trajectories that match the planned 
pre-procedural navigation trajectory divided by all performed navigation trajectories. The cases where the 
planned and performed navigation trajectories do not match, the reason for discrepancy will be presented. 
8.7.4. 
Secondary objective: Confidence level 
Objective 
To assess the confidence levels of interventional pulmonologists while using AirWaze (pre-procedural 
planning). 
 
Endpoint 
Confidence levels of pulmonologists are defined as a score (0-10) to examine the degree of confidence of 
specialists regarding: 
1) the localization of the lesion and planned navigation trajectory. 
2) reaching the first pulmonary lesion based on the planning. 
 
Analysis 
The level of confidence is scored between 0 and 10, respectively (not confident to very confident). The 
analysis includes a calculation of the mean, median and standard deviation assuming a normal distribution. 
This objective succeeds if the mean confidence level is 6.5 or higher for both confidence level scorings. More 
information about the confidence level can be found in  
 

 
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Appendix V: AirWaze Procedural Analysis.  
8.7.5. 
Secondary objective: Cognitive load during navigation 
Objective 
To assess the intraprocedural cognitive load of CBCT-guided NB. 
 
Endpoint 
The cognitive load of pulmonologists during the navigation of the first lesion will be measured with the 
Surgical Task Load Index (SURG-TLX) which is a validated method for measuring cognitive load, asked after 
tissue sampling of the first lesion 12,16,17.  
 
Analysis 
The objective will be expressed in the SURG-TLX, which is a score from 0 to 300 for the complexity of the task 
in the procedure based on a variety of demands. The analysis includes a calculation of the mean, medians 
and standard deviation assuming a normal distribution. Also the individual demands will be analyzed with 
calculated means, medians and standard deviations. More information about the cognitive load can be found 
in Appendix V: AirWaze Procedural Analysis.  
8.7.6. 
Secondary objective: Radiation exposure for patients and staff 
Objective 
To assess the radiation exposure for patients and staff. 
 
Endpoint 
• 
Radiation exposure for patients will be measured in effective dose (mSv) and DAP (Gy·cm2) per 
procedure including disaggregated fluoroscopy, CBCT and CBCT-FS scan dose. Also, the 
fluoroscopy time (minutes) will be measured. 
• 
Radiation exposure for staff is measured in an average scattered effective dose (mSv) per procedure 
at hand and chest.  
Analysis 
• 
The radiation exposure for patients will be expressed in an average effective dose and DAP per 
procedure. The average effective dose and DAP will be higher compared to conventional procedures, 
but the increase in radiation dose will be relatively low (Appendix VI: Radiation Dose of CBCT-guided 
NB). The analysis includes a calculation of the mean, medians and standard deviations for effective 
dose and DAP per procedure. 
• 
The radiation exposure for staff will be expressed in the average effective dose at hand and chest. 
The average effective dose and DAP will be higher compared to conventional procedures, but this 
increase in radiation dose will be relatively low (Appendix VI: Radiation Dose of CBCT-guided NB). 
The analysis includes a calculation of the mean, medians and standard deviations for effective dose 
at hand and chest.  
8.7.7. 
Secondary objective: Adverse events 
Objective 
Report all adverse events, except for the unreportable adverse events (section 15.4). 
 
Endpoint 
Adverse events, including information on the seriousness, treatment needed, resolution and relevant judgment 
concerning the causal relationship with the investigational devices, comparator or procedure will be 
summarized for safety information. 
 
Analysis 
The objective is descriptive with no performance requirements and no sample size has been calculated. 
All subjects will be included in this analysis. 
 

 
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All adverse events will be presented in a tabular format. 
8.7.8. 
Secondary objective: Adverse Device Effects 
Objective 
Report all adverse device effects. 
 
Endpoint 
Adverse device effects, including information on the seriousness, treatment needed, resolution and relevant 
judgment concerning the causal relationship with the investigational devices or procedure will be summarized 
for safety information. 
 
Analysis 
The objective is descriptive with no performance requirements and no sample size has been calculated. All 
subjects will be included in this analysis. 
 
All adverse device effects will be presented in a tabular format. 
8.7.9. 
Secondary objective: Device Deficiencies  
Objective 
Report all device deficiencies.  
 
Endpoint 
Device deficiencies, including any corrective actions taken during the study, if any, will be summarized for 
safety information. Device deficiencies that could have led to an SAE will be reported in the Clinical Study End 
Report. 
 
Analysis 
The objective is descriptive with no performance requirements and no sample size has been calculated. All 
subjects will be included in this analysis. 
 
All device deficiencies will be presented in tabular format. 
9. 
Data management 
 
All data will be recorded in a timely manner in the electronic Case Report Form (e-CRF), which will be provided 
by the sponsor. Conducting a clinical trial and the related use of e-CRFs should not detract from the routine 
data recording in the source documents. It should be clearly marked in the source medical records of the 
subject at the trial site that the subject is participating in a clinical trial. Source data must be available to 
document the existence of the subject and substantiate integrity of trial data collected. Source data must 
include the original documents related to the trial (e.g. procedure image data) and history of subject.  
e-CRF will be used to collect medical history, subjects' demographics, procedure-related information, follow-
up data, protocol deviations, adverse events and device deficiencies. The e-CRF will be used for data tracking, 
data review, data cleaning and issuing and resolving data queries. The e-CRF contains an audit trail for 
recording data and rectifying errors and reconciliation. Entered data will be verified via automatic edit checks 
and manual review. This e-CRF is a web-based e-CRF which is password protected and is 21 CFR part 11 
compliant. The database will be locked at the start of the final analysis. At the end of the study, the data will 
be stored as a frozen dataset and will be retained. 
 
The data from the subjects will be key-coded (pseudo anonymized) when entered in the e-CRF. The personal 
information related to the subjects (like name) is kept separately in the enrollment log at the hospital.  
Imaging data (Pre-operative (PET-)CT scans, Intraprocedural CBCT scans and (augmented) fluoroscopy 
scans) will be collected and exported. . Exported data will be de-identified. Procedure date and time will be 
recorded within the e-CRF and will be used to link the image data to the corresponding e-CRF data.  
 

 
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The following questionnaire information may be recorded directly in the e-CRF and should be considered as 
source data: 
- 
System Usability Scale (SUS) 
- 
Semi-structured Questionnaires – Intuitiveness of AirWaze features 
- 
Semi-structured Questionnaire – Qualitative assessment of developed algorithms 
- 
AirWaze procedural analysis. 
 
All data will be collected and stored in a secure location. 
9.1. 
 Retention period 
The investigator shall maintain the records related to this study during the feasibility clinical investigation and 
for a period according to national regulations. Philips will maintain the records for a period of device End of 
Life (EoL) plus 15 years after the clinical investigation with the device in question has ended, or, if the device 
is subsequently placed on the market after the last device has been placed on the market.  
 
The sponsor and principal investigator shall take measures to prevent accidental or premature destruction of 
these documents. 
10. 
Amendments to the Feasibility Clinical Investigation Protocol 
The Investigator Brochure, Clinical Investigation Protocol, CRFs, informed consent form and other subject 
information, or other clinical investigation documents such as instructions for use shall be amended as needed 
throughout the clinical investigation and document controlled.  
Documentation of changes shall include a description of the changes, justification of the changes and their 
potential impact on the performance, effectiveness, safety or other endpoints, and identification of the affected 
documents. 
The amendments to the Clinical Investigation Protocol and the subject's informed consent form shall be notified 
to, or submitted for approval to the MEC and regulatory authorities, if required. The version number and date 
of amendments shall be documented. The Principal investigator shall refrain from implementing any 
modifications to the CIP without agreement from the sponsor, MEC and regulatory authorities, if required. 
Changes to the Clinical Investigation Protocol will be made by the Sponsor. 
 
For non-significant changes of any document already approved by the MEC or competent authority (e.g. minor 
logistical or administrative changes, changes of monitor(s), telephone numbers, renewal of insurance) not 
affecting the rights, safety and well-being of human subjects or not related to the clinical investigation objectives 
or endpoints, will be provided for notification to the MEC and, where appropriate, regulatory authorities, in case 
required per local regulations. 
Significant changes (such as device modifications, and study procedures) shall be agreed upon with the 
principal investigator. Significant changes shall be submitted to and approved by the MEC and the Competent 
Authority (if applicable) before implementation. Exempt from this requirement are measures which have to be 
taken immediately in order to protect the participants.  
If the amendment impacts the integrity of the clinical investigation, the data collected before and after the 
amendment shall be analyzed statistically to assess the effect of the amendment on endpoint analysis. This 
analysis shall be included in the clinical investigation report. 
11. 
Deviations from the feasibility clinical investigation protocol 
The investigator is not allowed to deviate from the feasibility clinical investigation protocol (CIP) neither to enroll 
subjects that do not comply with all inclusion and exclusion criteria. Under emergency circumstances, 
deviations from the CIP to protect the rights, safety and well-being of human subjects may proceed without 
prior approval of the sponsor and the MEC. Such deviations shall be documented and reported to the sponsor 
and the MEC as soon as possible. The principal investigator shall promptly report any deviations from the CIP 
that affect the rights, safety or well-being of the subject or the scientific integrity of the clinical investigation, 
including those which occur under emergency circumstances, if required by the MEC or national regulations. 
 

 
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All deviations from the CIP will be documented with date, subject, reason, actions taken and if the deviation 
affects the subject's rights, safety and well-being or the scientific integrity of the feasibility clinical investigation. 
The deviation shall be notified to the sponsor as soon as possible via the site monitor. Deviations shall be 
discussed with the principal investigator(s) or authorized designer. Deviations will be reviewed by the sponsor 
and in case of serious or repetitive deviations, a corrective action plan may represent a need to initiate a 
corrective action plan with the principal investigator. In some cases, termination or suspension of the 
participation of a particular site or investigator. 
12. 
Device accountability 
Access to the investigational device shall be controlled and the investigational device shall be used only in 
the feasibility clinical investigation and according to the feasibility clinical investigation Protocol. 
The sponsor shall keep records to document the physical location of the investigational device from shipment 
of investigational device to the clinical site until return. 
 
The principal investigator shall keep records documenting the receipt, installation, use and return of the 
investigational device, including the name(s) of person(s) who received, used, or returned the device and the 
subject identification and date the device was used.  
13. 
Statements of compliance 
This feasibility clinical investigation shall be conducted in accordance with the feasibility clinical investigation 
protocol, and with the ethical principles that have their origin in the Declaration of Helsinki and all applicable 
regional and/or national regulations. Furthermore, the feasibility clinical investigation conducted in the 
European Union shall be conducted in accordance with the International Standards ISO 14155 Clinical 
investigation of medical devices for human subjects - Good clinical practice and the Medical Device Regulation.  
 
This feasibility clinical investigation shall not be started prior to obtaining a favorable opinion from a Medical 
Ethics Committee (MEC)/Institutional Review Board (IRB) and Regulatory authority (if required). Any additional 
requirements imposed by the MEC/IRB and/or regulatory authority/FDA shall be followed. 
 
Philips is the sponsor of this study and financing this study. There will be an agreement between the 
participating site/investigator and Philips IGT-S. Insurance shall be provided for the subjects participating in 
this clinical trial according to local law. 
 
14. 
Informed consent process 
Informed consent will be obtained from every subject in writing by the investigator or his authorized designee 
before any study procedures are started. The subject will be informed about all aspects that are relevant to the 
subject’s decision to participate in the trial, including the trial procedures and risks and benefits of participation 
in the feasibility clinical investigation. The investigator shall avoid any coercion or undue improper influence 
on, or inducement of, the subject to participate and shall not waive or appear to waive the subject's legal rights. 
Information is provided in native, non-technical language, which is understandable to the subject. Ample time 
should be provided for the subject to read and understand the informed consent form and to consider 
participation. The informed consent will include personally dated signatures of the subject and the principal 
investigator or an authorized designee responsible for conducting the informed consent process. A copy of the 
signed and dated informed consent form and any other written information will be provided to the subject. 
 
Investigator shall document the process in the subject source document and maintain the signed informed 
consent at the site. 
 
Subjects who are unable or unwilling to provide informed consent will not be included in the feasibility clinical 
investigation. 
 

 
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If new information becomes available that might significantly affect the subject’s future health and medical 
care, it shall be provided to the affected subject(s) in written form. If relevant, all affected subject(s) shall be 
asked to reconfirm their continuing informed consent in writing. 
14.1. 
Incapacitated subjects 
Not applicable. 
14.2. 
Minors 
Not applicable. 
14.3. 
Subject unable to give informed consent in case of emergency treatment 
Not applicable. 
15. 
Adverse event reporting 
15.1. 
Definitions 
 
Adverse Event  
ISO14155: Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the 
investigational medical device and whether anticipated or unanticipated 
NOTE 1 This definition includes events related to the investigational medical device or the comparator. 
NOTE 2 This definition includes events related to the procedures involved. 
NOTE 3 For users or other persons, this definition is restricted to events related to the use of investigational 
medical devices or comparators. 
 
EU-MDR: An Adverse Event (AE) is defined as any untoward medical occurrence, unintended disease or injury 
or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in 
the context of a clinical investigation, whether or not related to the investigational device. 
 
Adverse Device Effect 
ISO14155: Adverse event related to the use of an investigational medical device.  
NOTE 1 This definition includes adverse events resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational medical device 
NOTE 2 This definition includes any event resulting from use error or intentional misuse of the investigational 
medical device. 
 
Serious Adverse Event 
ISO14155: Adverse event that led to any of the following:  
a) death  
b) serious deterioration in the health of the subject, users, or other persons as defined by one or more of the 
following: 
1) a life-threatening illness or injury, or 
2) permanent impairment of a body structure or a body function including chronic disease, or 
3) In-patient or prolongation hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure of a body function. 
5) a chronic disease  
c) foetal distress, foetal death or a congenital abnormality or birth defect including physical or mental 
impairment 
 
EU-MDR: Any adverse event that led to any of the following:  
(a) death,  

 
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(b) serious deterioration in the health of the subject, that resulted in any of the following:  
(i) life-threatening illness or injury,  
(ii) permanent impairment of a body structure or a body function,  
(iii) hospitalization or prolongation of patient hospitalization,  
(iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a 
body structure or a body function,  
(v) chronic disease,  
(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect 
 
Serious Health Threat 
Signal from any adverse event or device deficiency that indicates an imminent risk of death or a serious 
deterioration in the health of subjects, users or other persons, and that requires prompt remedial action for 
other subjects, users or other persons 
Note 1: This would include events that are of significant and unexpected nature such that they become 
alarming as a potentially serious health hazard or the possibility of multiple deaths occurring at short intervals. 
 
Serious Adverse Device Effect (SADE) 
Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. 
 
Unanticipated Serious Adverse Device Effect  
ISO14155: Unanticipated Serious Adverse Device Effect (USADE) is a serious adverse device effect that by 
its nature, incidence, severity or outcome has not been identified in the current risk assessment 
NOTE Anticipated serious adverse device effect (ASADE) is an effect that by its nature, incidence, severity or 
outcome has been identified in the risk assessment. 
 
Device Deficiency 
ISO14155: Inadequacy of a medical device with respect to its identity, quality, durability, reliability, usability, 
safety or performance 
NOTE 1 Device deficiencies include malfunctions, use errors, and inadequacy in the information supplied by 
the manufacturer including labelling. 
NOTE 2 This definition includes device deficiencies related to the investigational medical device or the 
comparator 
 
EU-MDR: Any inadequacy in the identity, quality, durability, reliability, safety or performance of an 
investigational device, including malfunction, use errors or inadequacy in information supplied by the 
manufacturer. 
15.2. 
Reporting 
Any person identifying an event or information that could have an impact on subjects’, users’ or other persons’ 
safety, has an obligation to inform the principal investigator and the sponsor of their concerns. Signals from 
adverse events or device deficiencies that might indicate a serious health threat can be detected by either the 
sponsor or principal investigator but are evaluated by the sponsor. Any occurrence of a serious health threat 
can require a specific reporting process according to regulatory requirements. 
 
The investigator shall report to the Sponsor via the adverse event form or device deficiency form in the e-CRF 
promptly: 
a) any Adverse Event 
b) any Device Deficiency 
c) any new information concerning these events 
  
Investigator will report to the sponsor any Adverse Event of a type identified in the clinical investigation protocol 
as being critical to the evaluation of the results of that clinical investigation. 
 
Adverse events associated with users or other persons can be documented separately from adverse events 
associated with the subject, taking into account the data privacy regulations. 

 
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The investigator shall report all serious adverse events and device deficiencies that might have led to a Serious 
Adverse Event if appropriate action had not been taken, the intervention had not occurred, or if circumstances 
had been less fortunate are reported to the sponsor without unjustified delay. 
 
Investigator Reporting Requirements  
Event Classification  
Communication Method  
Communication Timeline  
Serious Adverse Event 
including Serious Adverse 
Device Effects  
Complete AE eCRF page with 
all available new and updated 
information  
Within 3 calendar days of first 
becoming aware of the event  
 
Adverse Event  
Complete AE eCRF page 
• No later than 10 working days 
after becoming aware of the 
information  
• Reporting required through 
the end of the study  
 
Device Deficiencies   
Note: Any Investigational Device 
Deficiency that might have led to a 
serious adverse event if a) suitable 
action had not been taken or b) 
intervention had not been made or c) if 
circumstances had been less fortunate 
is considered a reportable event.  
Complete eCRF page with all 
available new and updated 
information  
• Within 3 calendar days of first 
becoming aware of the event  
• Reporting required through 
the end of the study  
 
 
The investigator shall supply the Sponsor, upon the Sponsor’s request, with any additional information related 
to the safety reporting of a particular event. The Sponsor and Monitor can request access to this information 
at any time. 
Any adverse event experienced by the subject from the time of signing the informed consent until the 1-week 
follow-up visit will be recorded on the e-CRF. All AEs that are considered related to the investigational device 
or procedure will be followed until they have abated, or until a stable situation has been reached. 
The e-CRF will include the following information for adverse events: date of the adverse event, description, 
actions taken (including treatment), resolution, assessment of both the seriousness and the relationship to the 
investigational device, comparator and procedure. Information collected for device deficiencies is the date of 
device deficiency, whether this could have led to a Serious Adverse Device Effect (SADE) if a) suitable action 
had not been taken or b) intervention had not been made or c) if circumstances had been less fortunate.  
 
 
Sponsor will ensure review of the investigator's assessment of all adverse events and device deficiencies. 
Ongoing safety evaluation of the investigational device will be done to determine whether risk analysis needs 
to be updated.  
The Sponsor shall report to the competent authority and/or MEC all reportable events and safety updates as 
required following the reporting requirements and within the specified timelines as required per local legislation.  
 
Where necessary to ensure timely reporting, the sponsor may submit an initial report that is incomplete 
followed by a complete report.  
 
 

 
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15.3. 
Anticipated adverse device effects 
Anticipated adverse device effects are described below in Table 4. 
 
Table 4. Anticipated adverse device effects. 
 
Anticipated adverse device effects 
Sev
erity  
Likely incidence 
(PoH) 
Risk category 
Mitigation or treatment 
Hazardous situation 
Possible harm 
Wrong treatment 
decisions due to errors 
or missing information in 
Investigational Device. 
Patient exposed to 
inadequate / 
inappropriate 
treatment or 
diagnostic exposure 
during clinical use 
(F10) 
S1 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
Add a message in the user 
manual stating that feature is 
not for clinical decision-making. 
Permanent malfunction 
of the Interventional Tool 
or Interventional 
Workstation during an 
interventional procedure 
due to software or 
hardware failure. The 
result is that the user 
needs to continue the 
procedure on X-Ray 
modality without the 
Interventional Tool. 
No Health 
Consequences or 
Impact (F26) 
S0 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
No measures need to be taken 
The C-arc has been 
moved in the 
longitudinal and/or 
transversal direction 
invalidating the current 
registration. 
Patient exposed to 
incorrectly deployed 
biopsy/ablation tools 
during clinical use  
 
Possible harm is: 
- Bronchial 
hemorrhage (E0707) 
- Pneumothorax 
(E0734) 
- Procedure related 
complications (E21) 
- Delay to 
treatment/therapy 
(F05) 
S2 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
In the IFU, inform the clinical 
user that the C-arc should not 
be moved in the longitudinal 
and/or 
transversal 
direction 
anymore after planning, and 
what the possible impact is 
when it happens. 
The planned path is not 
at the right location due 
to a badly geometrically 
calibrated system 
(deviation after a long 
use), so the geometry 
space of 3D image is not 
matching the geometry 
space of 2D images 
(fluoro). 
Patient exposed to 
incorrectly deployed 
biopsy/ablation tools 
during clinical use  
 
Possible harm is: 
- Bronchial 
hemorrhage (E0707) 
- Pneumothorax 
(E0734) 
- Procedure related 
complications (E21) 
- Delay to 
treatment/therapy 
(F05) 
S2 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
Standard 
(field) 
service 
procedures will detect and 
correct 
badly 
calibrated 
systems. 
During roadmap the: 
- Table has been moved 
and/or 
- C-arc has been moved 
in the longitudinal or 
transversal direction 
Consequently, the 
alignment of the live 2D 
X-ray images with the 
3D volume may be 
incorrect. The clinical 
user neglects the visual 
Patient exposed to 
incorrectly deployed 
biopsy/ablation tools 
during clinical use  
 
Possible harm is: 
- Bronchial 
hemorrhage (E0707) 
- Pneumothorax 
(E0734) 
- Procedure related 
complications (E21) 
S2 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
For C-arc movement: 
Whenever the system detects, 
during 3D roadmapping, that 
the C-arc has been moved, 
the clinical user will be 
informed to check the 
alignment of the overlay of the 
2D X-ray images with the 3D 
volume.  
For AD5 table: 
Table is locked before start of 
3D roadmapping. Whenever 

 
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mismatch and bases his 
decisions only on the 
overlay image. 
- Delay to 
treatment/therapy 
(F05) 
the system detects, during 3D 
roadmapping, that the table 
has been unlocked, the clinical 
user will be informed to check 
the alignment of the overlay of 
the 2D X-ray images with the 
3D volume.  
For AD7 and Maquet table: 
Whenever the system detects, 
during 3D roadmapping that 
the table is tilted, pivoted or 
cradled, the user is informed 
to check the alignment of the 
2D Xray images and the 3D 
volume.  
(For other movements table 
tracking is implemented, so 
additional mitigation is not 
necessary). 
In case the system contains a 
table that does not support 
table position tracking, the 
following mitigation is 
applicable: 
The 
clinical 
user 
will 
be 
informed that in case he moves 
the table during roadmap the 
alignment will be lost. 
After the biopsy or 
ablation device planning 
and alignment with the 
X-ray system (i.e. 
XperCT or 2D X-ray 
registration),  
- Table has been moved 
and/or 
- C-arc has been moved 
in the longitudinal or 
transversal direction 
Consequently, the 
device planning may 
have become invalid. 
Based on incorrect 
anatomical overlay 
information the 
operator might deploy 
the device 
inaccurately. Possible 
harm is: 
• biopsy of incorrect 
tissue 
• airway or vessel 
inadvertent rupture by 
the guide wire 
• ablation of other 
essential tissue 
S2 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
Whenever the system detects 
that the Table and/or C-arc are 
not in the same position and 
orientation 
(head/side) 
as 
where the planning has been 
performed, the clinical user will 
be informed to check the 
alignment of the overlay of the 
2D X-ray images with the 3D 
volume. 
Patient movement 
during guidance phase; 
fluoro overlay on 
XperCT image and 
guiding graphics 
(planned path) do not 
match because patient, 
or patient tissue, has 
moved. As a result, the 
user will have to perform 
re-registration to correct 
the mismatch before 
proceeding. 
Patient exposed to 
incorrectly deployed 
biopsy/ablation tools 
during clinical use  
 
Possible harm is: 
- Bronchial 
hemorrhage (E0707) 
- Pneumothorax 
(E0734) 
- Procedure related 
complications (E21) 
- Delay to 
treatment/therapy 
(F05) 
S2 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
In the IFU, inform the clinical 
user that overlay might become 
unreliable if the patient moves 
during acquisition. 
Insufficient image quality 
No Health 
Consequences or 
Impact (F26) 
S0 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
No measures need to be taken. 
Large error in CT to 
CBCT registration which 
goes unchecked by 
physician during 
verification and 
subsequent biopsy / 
ablation in close 
proximity to fissure or 
pleura. 
Patient exposed to 
incorrectly deployed 
biopsy/ablation tools 
during clinical use  
 
Possible harm is: 
- Bronchial 
hemorrhage (E0707) 
S2 
PoH 2 - Not 
expected to occur 
(10— <100 per 
1000000) 
Acceptable 
The clinical user is shown 
registration 
results 
and 
explicitly asked to confirm or 
correct the registration. 

 
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- Pneumothorax 
(E0734) 
- Procedure related 
complications (E21) 
- Delay to 
treatment/therapy 
(F05) 
*Severity is defined according to: 
S0 – Negligible: Results in Inconvenience or temporary discomfort not requiring professional medical 
intervention OR in customer dissatisfaction where there is no injury. 
S1 – Minor: Results in injury or temporary impairment not requiring professional medical intervention 
S2 – Major: Results in injury or temporary impairment requiring professional medical intervention 
S3 – Critical: Results in permanent impairment OR in an injury, which is life-threatening if professional medical 
intervention is not obtained 
S4 – Catastrophic: Directly results in death 
15.4. 
Unreportable adverse events 
The following adverse events do not need to be reported if occurred in the timeframe indicated below.  
 
Table 5. Unreportable adverse events 
Unreportable adverse event 
Time frame 
Rationale 
Haemoptysis 
<48h 
May occur after bronchoscopy by 
causing damage to the airway walls 
or taking biopsies in the lung 
parenchyma. These inconveniences 
will disappear within 48 hours.  
Fever 
<48h 
May occur after the procedure. Is no 
reason for alarm and can be treated 
with antipyretic medication, such as 
paracetamol.  
16. 
Vulnerable population 
This section is not applicable. No vulnerable population. 
17. 
(Early) termination or suspension of the feasibility clinical 
investigation 
There are no provisions or interim analyses planned that can result in early termination of the trial. The principal 
investigator, MEC, or regulatory authority may suspend or prematurely terminate participation in the clinical 
investigation at the investigation sites for which they are responsible.  
Any signs of unknown or increased risks for the subjects will be discussed by the sponsor and investigator to 
assess the impact on the subjects and clinical investigation. If suspicion of an unacceptable risk to subjects 
arises during the clinical investigation, or when so instructed by the MEC or regulatory authorities, the sponsor 
shall suspend the clinical investigation while the risk is assessed. 
 
The sponsor shall terminate the clinical investigation if an unacceptable risk is confirmed.  
If suspension or premature termination occurs, the terminating party shall justify its decision in writing and 
promptly inform the other parties with whom they are in direct communication. The principal investigator and 
sponsor shall keep each other informed of any communication received from either the MEC or the regulatory 
authority.  
 
Serious or repetitive occurrences of deviations from study protocol or non-compliance with regulations may 
also be the reason for early termination or suspension of a study site. In such situations, there is no change to 
the planned standard of care follow-up of patients, and follow-up of adverse events. 
  

 
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The competent authority and the MEC will be informed in case of (early) termination or temporarily halt of the 
study, if required, according to the timelines established in national regulations. 
18. 
Publication policy 
It is the intention of the investigator and sponsor to submit the clinical investigation data for publication. Prior 
to submission, claims on intellectual property will be assessed by the Sponsor. 
 
Criteria for authorship are based on the following ICMJE guidelines: 19 
 
• 
Substantial contributions to the conception or design of the work; or the acquisition, analysis, or 
interpretation of data for the work; AND  
• 
Drafting the work or revising it critically for important intellectual content; AND  
• 
Final approval of the version to be published; AND  
• 
Agreement to be accountable for all aspects of the work in ensuring that questions related to the 
accuracy or integrity of any part of the work are appropriately investigated and resolved. 
 
This study will also be registered on clinicaltrials.gov before first enrollment and the content shall be updated 
throughout the conduct of the clinical investigation and the results entered at completion of the clinical 
investigation. The results will be submitted for publication within 6 months of primary completion date. 
 
 

 
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19. 
Bibliography 
 
1.  
Sung H, Ferlay J, Siegel RL, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and 
Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;71(3):209-249. 
doi:10.3322/caac.21660 
2.  
Wild, C.P., Weiderpass, E., Stewart BW. World Cancer Report: Cancer Research for Cancer Prevention. Lyon, 
France; 2021. http://publications.iarc.fr/586. 
3.  
Heerink WJ, de Bock GH, de Jonge GJ, Groen HJM, Vliegenthart R, Oudkerk M. Complication rates of CT-
guided transthoracic lung biopsy: meta-analysis. Eur Radiol. 2017;27(1):138-148. doi:10.1007/s00330-016-4357-
8 
4.  
Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the 
pulmonary nodule. Chest. 2012;142(2):385-393. doi:10.1378/chest.11-1764 
5.  
Chaddha U, Kovacs SP, Manley C, et al. Robot-assisted bronchoscopy for pulmonary lesion diagnosis: results 
from the initial multicenter experience. BMC Pulm Med. 2019;19(1):243. doi:10.1186/s12890-019-1010-8 
6.  
Folch EE, Pritchett MA, Nead MA, et al. Electromagnetic Navigation Bronchoscopy for Peripheral Pulmonary 
Lesions: One-Year Results of the Prospective, Multicenter NAVIGATE Study. J Thorac Oncol. 2019;14(3):445-
458. doi:10.1016/j.jtho.2018.11.013 
7.  
Casal RF, Sarkiss M, Jones AK, et al. Cone beam computed tomography-guided thin/ultrathin bronchoscopy for 
diagnosis of peripheral lung nodules: a prospective pilot study. J Thorac Dis. 2018;10(12):6950-6959. 
doi:10.21037/jtd.2018.11.21 
8.  
Folch EE, Bowling MR, Pritchett MA, et al. NAVIGATE 24-Month Results: Electromagnetic Navigation 
Bronchoscopy for Pulmonary Lesions at 37 Centers in Europe and the United States. J Thorac Oncol. 
2022;17(4):519-531. doi:10.1016/j.jtho.2021.12.008 
9.  
Kalchiem-Dekel O, Connolly JG, Lin I-H, et al. Shape-Sensing Robotic-Assisted Bronchoscopy in the Diagnosis 
of Pulmonary Parenchymal Lesions. Chest. 2022;161(2):572-582. doi:10.1016/j.chest.2021.07.2169 
10.  
Pritchett MA, Schampaert S, De Groot JAH, Schirmer CC, Van Der Bom I. Cone-Beam CT With Augmented 
Fluoroscopy Combined With Electromagnetic Navigation Bronchoscopy for Biopsy of Pulmonary Nodules. J 
Bronchology Interv Pulmonol. 2018;25(4):274. doi:10.1097/LBR.0000000000000536 
11.  
Verhoeven RLJ, van der Sterren W, Kong W, Langereis S, van der Tol P, van der Heijden EHFM. Cone-beam 
CT and Augmented Fluoroscopy-guided Navigation Bronchoscopy: Radiation Exposure and Diagnostic Accuracy 
Learning Curves. J Bronchology Interv Pulmonol. 2021;28(4):262-271. doi:10.1097/LBR.0000000000000783 
12.  
Kapp CM, Akulian JA, Yu DH, et al. Cognitive Load in Electromagnetic Navigational and Robotic Bronchoscopy 
for Pulmonary Nodules. ATS Sch. 2020;2(1):97-107. doi:10.34197/ats-scholar.2020-0033OC 
13.  
de Ruiter QMB, Karanian JW, Bakhutashvili I, et al. Endobronchial Navigation Guided by Cone-Beam CT-Based 
Augmented Fluoroscopy without a Bronchoscope: Feasibility Study in Phantom and Swine. J Vasc Interv Radiol. 
2020;31(12):2122-2131. doi:10.1016/j.jvir.2020.04.036 
14.  
Pritchett M, Schirmer C, van Alfen M, Schampaert S. NOVEL CBCT-BASED NAVIGATION PROTOTYPE FOR 
BRONCHOSCOPIC BIOPSY OF PERIPHERAL LUNG NODULES: A FEASIBILITY STUDY. Chest. 
2019;156(A831). doi:10.1016/j.chest.2019.08.794 
15.  
Brooke J. SUS: a retrospective. J Usability Stud. 2013;8:29-40. 
16.  
Wilson MR, Poolton JM, Malhotra. Neha, Ngo K, Bright E, Masters RSW. Development and validation of a 
surgical workload measure: the surgery task load index (SURG-TLX). World J Surg. 2011;35:1961-1969. 
17.  
Kennedy-Metz LR, Wolfe HL, Dias RD, Yule SJ, Zenati MA. Surgery Task Load Index in Cardiac Surgery: 
Measuring Cognitive Load Among Teams. Surg Innov. 2020;27(6):602-607. doi:10.1177/1553350620934931 
18.  
RICKMAN OB, MAHAJAN AK, HOGARTH DK, BHADRA K. "TOOL-IN-LESION” ACCURACY OF GALAXY 
SYSTEM: ROBOTIC-ASSISTED, ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY WITH INTEGRATED 
TOOL-IN-LESION-TOMOSYNTHESIS TECHNOLOGY: THE MATCH STUDY. Chest. 2022;162(4):A2650-
A2651. doi:10.1016/j.chest.2022.08.2165 
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ICMJE | Recommendations | Defining the Role of Authors and Contributors. 
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contributors.html. Accessed September 4, 2022. 
20.  
Rijksinstituut voor Volksgezondheid en Milieu. Gemiddelde effectieve dosis per type CT-onderzoek. 
21.  
REINDERS L, SOTIROPOULOS G, BARANOWSKI R, FONSECA L, LANGEREIS S, LAU K. ULTRA-LOW 
DOSE CONE-BEAM CT INCREASES POSITIVE DIAGNOSIS RATE OF PERIPHERAL NODULE 
BRONCHOSCOPY WHILE IMPROVING RADIATION SAFETY. Chest. 2022;161(6):A505. 
doi:10.1016/j.chest.2022.04.039 

 
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CBCT guided lung interventions 
Doc ID: XCY607-130895 
Rev: 04 
Date: 2024-Jun-19 
Page 41 of 56 
 
 
 
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Appendix I: System Usability Scale (SUS) of AirWaze 
The System Usability Scale (SUS) is a reliable tool for measuring the overall usability of a product or service. 
This score represents how usable and learnable the product or service is. The SUS questionnaire for the 
AirWaze investigational device will be conducted after every 4 procedures per operator. In total, the SUS 
questionnaire will be conducted approximately 9 times. The questionnaire consists of a 10-item 
questionnaire with five response options for respondents; from Strongly agree to Strongly disagree 15.  
 
Please indicate how much you disagree 
or agree with the following statements: 
Strongly 
Disagree 
Disagree 
Neutral 
Agree 
Strongly 
Agree 
1. I think that I would like to use the 
AirWaze Software Device frequently. 
 
 
 
 
 
2. I found the AirWaze Software Device 
unnecessarily complex. 
 
 
 
 
 
3. I thought the AirWaze Software Device 
is easy to use. 
 
 
 
 
 
4. I think that I would need the support of a 
technical person to be able to use the 
AirWaze Software Device. 
 
 
 
 
 
5. I found the various functions in the 
AirWaze Software Device were well 
integrated. 
 
 
 
 
 
6. I thought there was too much 
inconsistency in the AirWaze Software 
Device. 
 
 
 
 
 
7. I imagine that most people would learn 
to use these AirWaze Software Device very 
quickly. 
 
 
 
 
 
8. I found the AirWaze Software Device 
very awkward to use. 
 
 
 
 
 
9. I felt very confident using the AirWaze 
Software Device system. 
 
 
 
 
 
10. I needed to learn a lot of things before I 
could get going with these AirWaze 
Software Device. 
 
 
 
 
 

 
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Appendix II: CBCT-FS compared to CBCT 
 
CBCT-FluoroSweep 
1. What is the purpose of the CBCT-FS scan? 
a. Confirm tool-in-lesion 
b. Determine location of the catheter compared to the lesion 
c. Other, ….  
2. If confirm tool-in-lesion purpose, can you confirm tool-in-lesion based on the CBCT-FS scan? 
a. Yes, there is tool-in-lesion confirmation. 
b. No, there is no tool-in-lesion confirmation. 
c. Inconclusive, because ……  
3. If confirm tool-in-lesion purpose AND tool-in-lesion confirmation, is the tool-in-lesion center-strike 
or off-center18?  
a. Center-strike 
b. Off-center strike 
4. To what extent is the CBCT-FS imaging useful to reposition or continue (for all purposes)? 
 
Scan 
1 
Not useful at all 
2  
 
3 
 
4 
 
5 
Very useful 
CBCT-FS 
o 
 
o 
 
o 
 
o 
 
o 
 
 
5. Did you notice/experience any artefacts or glitches? If yes, please elaborate. 
…........................................................................................................................................... 
 
CBCT (gold-standard imaging) 
 
6. What is the purpose of the CBCT scan? 
a. Confirm tool-in-lesion 
b. Determine location of the catheter compared to the lesion 
c. Other, ….  
7. If confirm tool-in-lesion purpose, can you confirm tool-in-lesion (in all three orthogonal 
orientations) based on the CBCT scan? 
a. Yes, there is tool-in-lesion confirmation in all three orthogonal orientations. 
b. No, there is no tool-in-lesion confirmation. 
c. Maybe, the quality of the CBCT scan is not sufficient to determine tool-in-lesion 
confirmation. 
8. If confirm tool-in-lesion purpose AND tool-in-lesion confirmation, is the tool-in-lesion center-strike 
or off-center18?  
a. Center-strike 
b. Off-center 
c. Lesion is too small to define center-strike or off-center*  
9. Did the CBCT scan change your plan based on the CBCT-FS? 
a. Yes 
b. No 
10. Did you notice/experience any artefacts or glitches? If yes, please elaborate. 
…........................................................................................................................................... 
* The lesion size is comparable to the catheter size.  

 
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Appendix III: Semi-structured Questionnaires – Assessment of the 
intuitiveness of AirWaze features 
The AirWaze study is focused on researching the intuitiveness of the different AirWaze features. These 
semi-structured questionnaires will be conducted after every 4 procedures per operator. 
 
The AirWaze software feature is intuitive (from a clinical perspective) to use: 
 
AirWaze feature 
1 
Strongly 
disagree 
2  
Disagree 
3 
Neutral 
4 
Agree 
5 
Strongly 
agree 
Advanced planning 
software 
o 
 
o 
 
o 
 
o 
 
o 
 
Augmented 
fluoroscopy 
o 
 
o 
 
o 
 
o 
 
o 
 
Automatic device 
detection 
o 
 
o 
 
o 
 
o 
 
o 
 
Directional guidance 
software 
o 
 
o 
 
o 
 
o 
 
o 
 
CBCT-FluoroSweep 
 
 
o 
 
o 
 
o 
 
o 
 
 
Additional questions: 
 
1. Is the information displayed visible/readable? If not, what could be improved? 
a. Yes 
b. No, because …................................................................................................. 
c. Other, …........................................................................................................... 
 
 
2. Was the relevant information that you need in the decision-making visible? If yes, what was most 
important information for you? If not, what could be improved? 
a. Yes, ….............................................................................................................. 
b. No, because …................................................................................................. 
c. Other, …........................................................................................................... 
 
3. Based on your experience, what aspects of the AirWaze software solution are most valuable to 
you?  
 
………………………………………………………………………………………………………………… 
 
4. What is still missing in the AirWaze software solution and/or what feature should still be further 
improved? 
 
…………………………………………………………………………………………………………… 
 
 

 
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5. What are the top three advantages that you experienced when using the AirWaze investigational 
device? 
a.  _________ 
b.  _________ 
c.  _________ 
6. What are the first three disadvantages that come to your mind when using the AirWaze   
 investigational device? 
a.  _________ 
b.  _________ 
c.  _________ 
7. Any other comment? 
………………………………………………………………………………………………………………… 
 
 

 
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Appendix IV: Semi-structured Questionnaire for quantitative and 
qualitative assessment of the developed algorithms  
 
The quality of the algorithms will be assessed through this questionnaire and will be conducted after 
every procedure per operator. 
 
Advanced planning software 
The advanced planning software contains two major algorithms for: 1) segmentation of the bronchial tree, 
and 2) image registration. 
 
1. Segmentation of the bronchial tree 
 
The segmentation of the bronchial tree is rated independently from the location of the lesion.  
- 
1: Only the trachea, right/left main bronchus, and bronchus intermedius are segmented. 
- 
2: RB1 t/m RB10 and LB1 t/m LB10 are segmented. 
- 
3: Few (1-2) branches beyond the RB or LB branches are segmented.  
- 
4: More (≥ 3) branches beyond the RB or LB branches are segmented to 2 cm from the pleura.  
- 
5: Bronchioles on a distance < 2 cm from the pleura are segmented.  
 
a. Please rate the quality of the segmented bronchial tree on the preoperative CT scan:  
 
1 
2 
3 
4 
5 
Segmentation 
failed 
Please elaborate: 
 
 
b. Based on the segmentation of the bronchial tree, is there a bronchus sign? 
a. Yes, there is a bronchus sign.  
b. No, there is no bronchus sign.  
c. Cannot be determined, because insufficient level of bronchial tree segmentation. 
 
c. If not sufficient level of bronchial tree segmentation: Do you have any clue what was the origin of 
the unacceptable segmentation? 
 ………………………………………………………………………………………….. 
 
d. Did you notice/experience any glitches? If yes, please elaborate.  
 ………………………………………………………………………………………….. 
 
 
 

 
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2. Image registration 
The image registration is bad if the registration around the target of interest shows large errors. The 
image registration is excellent if the images are registered accurately around the target of interest. 
 
The image registration is evaluated between the different CBCT-scans made during the procedure. The 
most recent acquired image is the fixed image, and the older acquired image is the moving image.  
In future AirWaze implementation, it is desirable to replace the CBCT with the low-dose CBCT-FS. In 
those procedures one normal-dose CBCT is acquired. The navigation trajectory and lesion segmentations 
are moved from the CBCT image to the CBCT-FS images. If there are less CBCT(-FS) performed, the 
image registration is addressed as N/A.  
 
a. Please rate the quality of the image registration at the location of the lesion: 
 
Image registration 
between moved and 
fixed scans 
1 
Bad 
2  
Poor 
3 
Fair 
4 
Good 
5 
Excellent 
Image 
registration 
failed 
Pre-op CT --> CBCT1 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
CBCT1 --> CBCT-FS1 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
…….… --> ……........... 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
…….… --> ……........... 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
…….… --> ……........... 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
 
b. If not acceptable level of image registration: Can it be corrected manually? And do you have any 
clue for the origin of the unacceptable levels of image registration? 
………………………………………………………………………………………….. 
 
c. Did you notice/experience any glitches? 
………………………………………………………………………………………….. 
Automatic device detection  
The automatic device detection is poor if the device is barely or wrongly detected. The automatic device 
detection is excellent if the device is detected completely. 
 
1. Please rate the quality of the automatic catheter detection during the procedure after acquiring a 
CBCT scan: 
Scan 
1 
Bad 
2  
Poor 
3 
Fair 
4 
Good 
5 
Excellent 
Automatic 
device detection 
failed 
CBCT1 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
CBCT-FS1 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
…….… 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
…….… 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
…….… 
o 
 
o 
 
o 
 
o 
 
o 
 
o 
 
 

 
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2. If not acceptable level of automatic device detection. What is in your view the origin of the 
unacceptable levels of automatic device detection? 
 ………………………………………………………………………………………….. 
 
3. Did you notice/experience any glitches? If yes, please elaborate.  
 
………………………………………………………………………………………….. 
 
 
 

 
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Appendix V: AirWaze Procedural Analysis  
PART A: Pre-Procedural Planning 
OPERATOR:  
STUDY CODE:  
1) Time start planning?  
 
(Measured from opening preoperative CT 
scan OR from opening AirWaze) 
… : … 
2) Catheter curvature for 
navigating to target lesion?  
o 
180   
o 
Medial 
o 
Other, please specify... 
3) Bronchus sign? 
 
o 
Yes 
 
o 
No 
o 
Maybe 
4) Pulmonary branch for 
navigation 
 
o 
RB 1 
o 
RB 2        
o 
RB 3         
o 
RB 4 
o 
RB 5 
o 
RB 6 
o 
RB 7 
o 
RB 8 
o 
RB 9 
o 
RB 10 
o 
LB 1+2        
o 
LB 3         
o 
LB 4 
o 
LB 5 
o 
LB 6 
o 
LB 8 
o 
LB 9 
o 
LB 10 
o 
Anatomical deviation: 
…….. 
5) How would you describe your planned 
trajectory? Be as specific as possible. 
 
(In the post-procedural questionnaire, you will 
evaluate whether your trajectory prediction was 
accurate).  
…………………………………………………………… 
 
 

 
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6) Time end planning?  
 
(Measured till the closing of the pre-
operative CT scan during the pre-
procedural planning (e.g. control group) 
OR till closing AirWaze).   
 
… : … 
7) Total planning time? 
………….. minutes of planning time  
8) How complex was the lesion 
localization and trajectory 
planning, to the first target lesion? 
Low                                                                                                   High 
 0       1        2        3        4        5        6        7        8        9      10 
9)  How confident are you that 
you have accurately localized and 
planned the trajectory to the first 
pulmonary target lesion? 
Low                                                                                                    High 
  0       1        2        3        4        5        6        7        8        9      10 
10)  Based on the planning, how 
complex do you expect the 
CBCT-guided bronchoscopy 
towards the first lesion to be? 
Low                                                                                               High 
0       1        2        3        4        5        6        7        8        9      10 
11) Based on the planning, how 
confident are you that you are 
going to successfully reach the 
first pulmonary target lesion?  
 Low                                                                                                  High 
 0       1        2        3        4        5        6        7        8        9      10 
12) Comments regarding the pre-
procedural planning?  
(e.g. quality (PET-)CT, software 
bugs, distractions) 
…………………………………………………………… 
 

 
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PART B: Intra-procedural navigation SURG-TLX Form 
OPERATOR:  
 
STUDY CODE:  
 
 
 
 
1) How would you rank the demands related to the navigation to the first target 
pulmonary lesion from less important to most important demand (scale 0 to 5)? You 
are only allowed to use every number once.  
 
o 
Mental demand: ………… 
o 
Physical demand: ……… 
o 
Temporal demand: …… 
o 
Task complexity: ……… 
o 
Situational stress: ……… 
o 
Distractions: ……… 
 
 
0 
 
 
 
 
5 
 
 
 
 
10 
 
 
 
 
15 
 
 
 
 
 
20 
 
1A) Mental demands: How 
mentally fatiguing was the 
navigation? 
Very Low 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very High 
1B) Physical demands: 
How physically fatiguing 
was the navigation? 
Very Low 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very High 
1C) Temporal demands: 
How hurried or rushed was 
the pace of the 
navigation? 
Very Low 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very High 
1D) Task complexity: How 
complex was the 
navigation? 
Not Very 
Complex 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very 
Complex 
1E) Situational stress: How 
anxious did you feel while 
performing the 
navigation? 
Not Very 
Anxious 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very 
Anxious 
1F) Distractions: How 
distracting was the 
operating work environment 
during the navigation? 
Not Very 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Very 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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PART C: End-procedural Form 
OPERATOR:  
STUDY CODE:  
1) Was the lesion targeted 
successfully? 
 
o 
Yes 
 
 
o 
No 
 
2) Curvature catheter (for target 
lesion)?  
o 
Medial 
o 
180  
o 
Other  
3) Does the performed 
navigation trajectory match the 
trajectory as planned in the pre-
procedural form?   
 
 
o 
Yes 
 
 
o 
No 
 
 
4) Which situation matches the 
performed navigation trajectory 
compared to the pre-procedural 
trajectory of the operator? 
 
 
The performed trajectory….. 
 
 
 
o 
fully matches the planned trajectory. 
o 
bifurcates different late in the navigation. 
o 
bifurcates different early in the navigation. 
o 
is mispositioned. 
o 
has a transparenchymal route instead of an endobronchial 
route. 
o 
has an endobronchial route instead of a transparenchymal 
route. 
o 
does not reach the target at all. 
o 
is hard to compare with the planned trajectory, because of 
atelectasis or displacement of the lesion. 
o 
Other, ………………………………………  
 
5) To what extent did the 
planning contribute to reaching 
the first target lesion? 
  
Low                                                                                                          High    
 0       1         2         3         4         5         6         7        8        9      10 
6) Effective dose fluoroscopy and 
time fluoroscopy radiation during 
navigation and confirmation of first 
target lesion?  
…… 
mSv 
……… 
Gy*cm2 
………… 
fluoroscopy time (s) 
7)  Effective dose CBCT and No. of 
CBCT scans during navigation and 
confirmation of first target lesion? 
…… 
mSv 
……… 
Gy*cm2 
………….. CBCT 
scans (n) 
8) Effective dose CBCT-FS and 
No. of CBCT-FS scans during 
navigation and confirmation of first 
target lesion? 
….. 
mSv 
……… 
Gy*cm2 
………….. CBCT-
FS scans (n) 

 
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9) Average (scattered) radiation 
dose staff (main operator)? 
 
 
…............ mSv  
(ring dosimeter) 
 
…............. mSv  
(chest dosimeter) 
9) ROSE pathology outcome 
 
o 
Malignant 
o 
Atypical cells 
 
o 
Benign specific 
o 
Benign non-specific 
o 
Not representative  
10) Patient Safety issues?  
 
(To be reported in the Clinical Study End 
Report) 
o 
Yes, adverse events, namely: …………………………. 
o 
Yes, adverse device effects namely: …………………………. 
o 
Yes, device deficiencies, namely: ………………………… 
12) Comments regarding the 
AirWaze software tools during the 
procedure?  
 
 
(Quality CBCT or CBCT-FS scans, software 
bugs, distractions in OR, other) 
 

 
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Appendix VI: Radiation Dose of CBCT-guided NB 
Besides the learning curve related to the high cognitive load of CBCT-guided NB in current clinical practice, 
the overall radiation exposure is a point of concern in image-guided interventions. Literature studies have 
reported on radiation exposure with CBCT and AF in interventional pulmonology. For instance, Casal et al. 
reported a dose area product (DAP) and effective dose of 64.6 Gycm2 and 11-29 mSv per procedure, 
respectively 7. More recently, Verhoeven et al. reported on procedural radiation exposure during CBCT-
guided bronchoscopy for biopsy of peripheral lung nodules 11. The procedural radiation dose was initially 
47.5 Gy·cm2 (effective dose: 14.3 mSv) and gradually reduced to 25.4 Gy·cm2 (effective dose: 5.8 mSv), due 
to increased experience and different fluoroscopic and CBCT protocols including the latest Philips Azurion 
system. The reduction in fluoroscopic DAP was highest, from 19.0 Gy·cm2 (effective dose: 5.2 mSv) to 2.2 
Gy·cm2 (0.37 mSv, 88% reduction), despite a significant increase of fluoroscopy time 11. In comparison, a 
diagnostic CT scan of the thorax has an average effective dose of 7.8 mSv 20. Even though the radiation 
exposure of CBCT-guided NB is acceptable, the ALARA principle (As Low As Reasonably Achievable) must 
be maintained. Radiation exposure is encountered to a learning curve, meaning that with an increased level 
of performance, the radiation exposure decreases 11,21. 
 
The procedural radiation dose in the study set-up of Verhoeven et al. can be divided into the Fluoroscopy DAP 
and the CBCT DAP11. The low dose fluoroscopy DAP using the Azurion system was on average 2.2 Gy·cm2 
in total per procedure with 935 seconds of fluoroscopy time per procedure (n=43). The DAP per CBCT 
rotational acquisition using the Azurion system was for the original dose protocol 11.6 Gy·cm2 using on average 
2.25 acquisitions per procedure resulting in a total DAP of 28.2 Gy·cm2 (n=13). Additionally, for the low dose 
protocol the average DAP was 8.02 Gy·cm2 using on average 2.93 acquisitions per procedure resulting in a 
total DAP of 25.4 Gy·cm2 (n=30). The relevant data from this study are provided in Table 6.  
 
Table 6. Radiation exposure of CBCT-guided NB11 
Sample 
size 
System 
Fluoroscopy 
CBCT 
Total 
DAP 
Protocol 
DAP 
Time (s) 
Protocol 
DAP/ 
acquisition 
Acquisitions 
n=13 
Azurion 
Low dose 
2.2 
935 
Normal dose 
11.55 
2.25 
28.2 
n=30 
Azurion 
Low dose 
8.02 
2.93 
25.4 
 
The estimated radiation exposure of the AirWaze study is depicted in Table 7. 
 
• 
Radiation exposure assumptions: 
o 
Verhoeven et al. has reported the radiation exposure of CBCT-guided navigation 
bronchoscopy for biopsy of PPNs. An average fluoroscopy time of 935 seconds was used for 
real-time navigation and sampling guidance. The average total DAP for these 935 seconds 
was 2.2 Gycm2. 
o 
It is expected that the implementation of AirWaze CBCT-FS will reduce the fluoroscopy time 
and thus the overall DAP. This benefit of an expected reduction in fluoroscopy time is not 
considered in the calculations as depicted in Table 7. 
 
• 
AirWaze and CBCT-FS are implemented for testing the clinical and technical feasibility. The first 
performed scan during a procedure is a conventional CBCT. In case additional scans are required, a 
CBCT-FS scan is performed on top of the conventional imaging protocol. A comparison between the 
additional CBCT and CBCT-FS is then made. The DAP per CBCT-FS acquisition is less than 1.45 
Gy·cm2 based on preclinical studies.   
 
 

 
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Table 7. Expected estimated radiation exposure during this Feasibility Clinical Investigation 
 
Low Dose 
Fluoroscopy 
CBCT 
CBCT-FS* 
Total DAP 
(Gy·cm2) 
DAP 
(Gy·cm2) 
Time (s) 
Protocol 
DAP  
(Gy·cm2) / 
acq. 
Acqs. 
DAP 
(Gy·cm2) / 
acq. 
Acquisitions 
CBCT-NB 
w/o AirWaze 
2.2 
935 
Normal 
dose 
11.55 
1 
- 
- 
20.8-37.8 
Low dose 
8.02 
1-3 
Study (n=22) 
2.2 
935 
Normal 
dose 
11.55 
1 
- 
- 
22.3-42.2 
Low dose  
8.02 
1-3 
1.45 
1-3 
* The number of CBCT-FS scans are expected to be equal to the number of additional low dose CBCT scans 
performed (=total number of CBCT minus one). 
 
In current standard of care of CBCT-guided NB, the staff is exposed to scattered radiation during the 935 
seconds of fluoroscopy. All staff members are leaving the operation room (OR) during CBCT-image acquisition 
and are therefore not exposed to scattered radiation. During CBCT-FS, it is not required for the staff to leave 
the room. This is one of the reasons why the scans can increase the staff dose. The expected increase will 
not be visible in this study, since the staff will already leave the OR during CBCT, and will most likely be outside 
the OR during the CBCT-FS at that same moment. Some measures and expected effects will diminish radiation 
exposure for staff, such as the use of lead shields and increasing distance to the source (inversed quadratic 
relationship). It is also expected that the total fluoroscopy time will be reduced by using AirWaze and CBCT-
FS since navigation guidance and tool-in-lesion visibility has been improved. To measure the staff (scattered) 
radiation dose, we apply two dosimeters (head and chest) on all attending operators during all procedures 
performed in this study to measure the exact effects. 
 
The dose area product (DAP) and effective dose will be measured, as proposed by Verhoeven et al. 11. During 
this study, the indirect radiation bundle for the staff closest to the CBCT is measured at the hand and chest 
with validated dosimeters which are commercially available. 
 
 
 

 
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Appendix VII: Roles, responsibilities and qualifications of Investigators 
 
Roles and Responsibilities of investigators 
 
The investigator:  
a) has the responsibility to implement and manage the day-to-day conduct of the clinical study as well as to 
ensure data integrity and the rights, safety and well-being of the subjects involved in the clinical study. 
b) shall ensure proper communication with the EC as described in ISO14155 
c) shall ensure compliance with the applicable regulatory requirements and ethical principles for the process 
of obtaining informed consent as described in ISO14155.  
d) shall conduct the clinical investigation in compliance with the clinical protocol as described in ISO14155.  
e) shall provide adequate medical care as described in ISO14155.  
f) shall ensure safety reporting as described in ISO14155. 
g) has the required number of eligible subjects needed within the agreed recruitment period, and 
h) can demonstrate that the investigation site has one or more qualified investigators, a qualified investigation 
site team and adequate facilities for the foreseen duration of the clinical investigation.  
 
Qualification of the investigator 
 
Before the start of the study, the principal investigator shall be qualified in accordance with ISO14155:  
a) by education, training and experience to assume responsibility for the proper conduct of the clinical 
investigation.  
b) by experience in the field of application and training in the use of the investigational device under 
consideration. 
c) by the disclosure of potential conflicts of interest, including financial, that interfere with the conduct of the 
clinical investigation or interpretation of results, and 
d) be knowledgeable about the method of obtaining informed consent.  
 
 
 
 

 
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Date: 2024-Jun-19 
Page 56 of 56 
 
 
 
Form ID: XCT-0302017 rev.17 / 2022 Jul 11 
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