Lung DiseasesNCT06046001

AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

A study testing AirWaze in people with Lung Diseases, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to assess the overall usability of the Philips AirWaze investigational device in patients indicated for CBCT-guided navigation bronchoscopy procedure. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Diseases
What is being tested?: AirWaze
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 1 siteNetherlands
Study dates: 27 Oct 2023to 3 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.
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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Radboudumc
Nijmegen, Gelderland

Other trials in Netherlands

About this study

The goal of this clinical trial is to assess the overall usability of the Philips

AirWaze investigational device in patients indicated for CBCT-guided navigation bronchoscopy procedure. The main questions it aims to answer are to assess the:

overall usability of the device
accuracy of the tool-in-lesion confirmation scan

Participants will undergo bronchoscopy with the new navigation device and additional confirmation scans. Follow-up visit at 7days will be performed.

Conditions: Lung Diseases
Being tested: AirWaze
Medical subject headings: Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AirWazeDevice
AirWaze - easy and advanced tools for CBCT guided lung interventions

Study groups in NCT06046001
Study group	Role	What they receive
AirWaze	Experimental	AirWaze - easy and advanced tools for CBCT guided lung interventions Receives: Device: AirWaze

What is being measured

The primary outcome is the main question the study is designed to answer.

System Usability Scale (SUS)
System Usability Scale (SUS) of AirWaze investigational device. 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. The questionnaire consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Minimum total score is 0 and maximum, 100.
Measured: after procedure, up to 2 hours
Number of Participants With Accurate Tool-in-lesion Confirmation Scan (Ultra-low Dose CBCT Scan) Compared to the Conventional Tool-in-lesion Confirmation Scan (CBCT Scan)
Accuracy of the tool-in-lesion confirmation scan (ultra-low dose CBCT scan) is defined as the number of participants where ultra-low dose CBCT 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 scans in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true positives), and the number of no tool-in-lesion confirmation in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true negatives), divided by the total number of ultra-low dose CBCT and conventional CBCT scan pairs.
Image based tool-in-lesion confirmation accuracy of 90% will indicate that the ultra-low dose CBCT scan is postulated to be sufficient for navigation bronchoscopy.
Measured: after procedure, up to 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Oct 20233 Jan 2025

First posted21 Sep 2023
Study start27 Oct 2023
Primary completion20 Dec 2024
Study completion3 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06046001
Sponsor's protocol ID: XCY607-130895
Status last verified: Mar 2026
First submitted: 4 Sep 2023
Last updated: 16 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions
ClinicalTrials.gov ID: NCT06046001
Acronym / sponsor ID: XCY607-130895
Conditions: Lung Diseases
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
Study start: 27 Oct 2023 (actual)
Primary completion: 20 Dec 2024 (actual)
Study completion: 3 Jan 2025 (actual)
First posted: 21 Sep 2023 (actual)
Results: Posted 16 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The goal of this clinical trial is to assess the overall usability of the Philips

AirWaze investigational device in patients indicated for CBCT-guided navigation bronchoscopy procedure. The main questions it aims to answer are to assess the:

overall usability of the device
accuracy of the tool-in-lesion confirmation scan

Participants will undergo bronchoscopy with the new navigation device and additional confirmation scans. Follow-up visit at 7days will be performed.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
AirWaze	Experimental	Device: AirWazeAirWaze - easy and advanced tools for CBCT guided lung interventions

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (17 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AirWazeAirWaze - easy and advanced tools for CBCT guided lung interventions	Device	AirWaze

Primary outcome

System Usability Scale (SUS)
Time frame: after procedure, up to 2 hours
System Usability Scale (SUS) of AirWaze investigational device. 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. The questionnaire consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Minimum total score is 0 and maximum, 100.
Number of Participants With Accurate Tool-in-lesion Confirmation Scan (Ultra-low Dose CBCT Scan) Compared to the Conventional Tool-in-lesion Confirmation Scan (CBCT Scan)
Time frame: after procedure, up to 1 hour
Accuracy of the tool-in-lesion confirmation scan (ultra-low dose CBCT scan) is defined as the number of participants where ultra-low dose CBCT 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 scans in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true positives), and the number of no tool-in-lesion confirmation in both the ultra-low dose CBCT and conventional CBCT scans (i.e. true negatives), divided by the total number of ultra-low dose CBCT and conventional CBCT scan pairs. Image based tool-in-lesion confirmation accuracy of 90% will indicate that the ultra-low dose CBCT scan is postulated to be sufficient for navigation bronchoscopy.

Results and safety

Results posted to the registry on 16 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AirWaze (Enrolled Population)	37	34

Primary outcome: System Usability Scale (SUS)

Time frame: after procedure, up to 2 hours. Mean (Standard Deviation). Unit: units on a scale

Measure	AirWaze (Per Protocol Population) n = 34
Value	44.7 (24.35)

Primary outcome: Number of Participants With Accurate Tool-in-lesion Confirmation Scan (Ultra-low Dose CBCT Scan) Compared to the Conventional Tool-in-lesion Confirmation Scan (CBCT Scan)

Time frame: after procedure, up to 1 hour. Count of participants. Unit: Participants

Measure	AirWaze (Per Protocol Population) n = 25
Value	21

Population analysed: All participants with an ultra-low dose CBCT scan and a conventional CBCT scan to confirm tool-in-lesion with the same catheter and tool position, are included in this analysis. For 9 of the 34 participants, no ultra-low dose CBCT scan and/ or conventional CBCT scan was performed to confirm tool-in-lesion and therefore no tool-in-lesion accuracy was determined.

Adverse events

Time frame: from enrollment until end of follow-up, up to 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AirWaze (Enrolled Population)	2 of 37 (5.4%)	4 of 37 (10.8%)	0 of 37

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 2/3
Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7
Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
RecruitingPhase 3
A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
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Not yet recruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Erik van der Heijden principal investigator

Radboudumc Nijmegen, Netherlands

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing AirWaze in people with Lung Diseases, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

System Usability Scale (SUS) (time frame: after procedure, up to 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.