AirWaze - easy and advanced tools for CBCT guided lung interventions

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 37

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 course of 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 & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br><br /><br>- System Usability Score (SUS) of AirWaze investigational device.<br /><br>- Accuracy of the tool-in-lesion confirmation scan CBCT-FS compared to the<br /><br>conventional CBCT (gold-standard) based on tool-in-lesion definitions and<br /><br>usefulness of the scans in order to guide to the lesion.</p><br>

Secondary Outcome Measures