AirWaze - Easy and Advanced Tools for CBCT Guided Lung Interventions

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.
• •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.