AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

NCT06046001 | Completed Results

• 1 other identifier: XCY607-130895
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  after procedure, up to 1 hour

Study Arms (1)

AirWaze

EXPERIMENTAL

AirWaze - easy and advanced tools for CBCT guided lung interventions

Device: AirWaze

Interventions

AirWaze DEVICE

AirWaze - easy and advanced tools for CBCT guided lung interventions

AirWaze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, Netherlands

Location

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Results Point of Contact

• Title: Pim van Lochem
• Organization: Philips Medical Systems Nederland B.V.

pim.vanlochem@philips.com

+31 6 18 19 87 71

Study Officials

• Erik van der Heijden

  Radboudumc Nijmegen, Netherlands

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: September 21, 2023
• Study Start: October 27, 2023
• Primary Completion: December 20, 2024
• Study Completion: January 3, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-03

Locations

NL (1)