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NCT06046001

AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

Completed NA Results posted Last updated 16 April 2026
What this trial tests

NA trial testing AirWaze in Lung Diseases in 37 participants. Completed in 3 January 2025.

Timeline
27 October 2023
Primary endpoint
20 December 2024
3 January 2025

Quick facts

Lead sponsorPhilips Clinical & Medical Affairs Global
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment37
Start date27 October 2023
Primary completion20 December 2024
Estimated completion3 January 2025
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Philips Clinical & Medical Affairs Global — full company profile →

Who can join

18 and older, any sex, with Lung Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

System Usability Scale (SUS) Primary · 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.

GroupValue95% CI
AirWaze (Per Protocol Population)44.7± 24.35
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) Primary · 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 CBC

GroupValue95% CI
AirWaze (Per Protocol Population)21

Adverse events — posted to ClinicalTrials.gov

Time frame: from enrollment until end of follow-up, up to 1 week. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

AirWaze (Enrolled Population)
Serious: 2/37 (5%)
Deaths: 0/37

Serious adverse events (2 terms)

ReactionSystemAirWaze (Enrolled Populati…
Chest painCardiac disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Other adverse events (4 terms — click to expand)

ReactionSystemAirWaze (Enrolled Populati…
Back painNervous system disorders
BleedingInjury, poisoning and procedural complications
FeverInfections and infestations
PneumoniaRespiratory, thoracic and mediastinal disorders

Most-reported serious reactions: Chest pain, Dyspnea.

Data from ClinicalTrials.gov NCT06046001 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Lung Diseases

Currently open trials in the same condition.

Other Philips Clinical & Medical Affairs Global trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06046001.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing