AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

March 27, 2026 updated by: Philips Clinical & Medical Affairs Global

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands
        • Radboudumc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AirWaze
AirWaze - easy and advanced tools for CBCT guided lung interventions
Device: AirWaze
AirWaze - easy and advanced tools for CBCT guided lung interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
after procedure, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Philips Clinical & Medical Affairs Global

Investigators

  • Principal Investigator: Erik van der Heijden, Radboudumc Nijmegen, Netherlands

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2023

Primary Completion (Actual)

December 20, 2024

Study Completion (Actual)

January 3, 2025

Study Registration Dates

First Submitted

September 4, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

March 27, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XCY607-130895

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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