Open (masking not used), Uncontrolled, Parallel, Diagnostic

N/A

The primary objective of this safety and efficacy study is to assess the overall diagnostic yield. Diagnostic yield is defined as the number of times the procedure was diagnostic (either malignant or benign), relative to the total number of attempted navigation procedures. The criteria for what constitutes a diagnostic sample will be modelled after the strict definitions as proposed by Vachani et al. (Vachani et al. Chest, 2020). When applying this definition, a diagnosis can only be determined based on pathology results from the study procedure and without follow-up information. Diagnostic outcomes are malignant or specific benign diagnoses (e.g., granulomatous inflammation, fungal infection). All other findings are categorized as non-diagnostic. This definition allows for a conservative analysis of the outcomes, and has strong clinical applicability.

• ASA physical status 1-3
• Age above 18 years
• A single pulmonary nodule with an indication for diagnostic evaluation following current clinical guidelines
• Subject is willing and able to give written informed consent for clinical investigation participation prior to the procedure

• Contra-indication for navigation bronchoscopy
• Not fit to undergo navigation bronchoscopy
• Patient is pregnant
• Inability to consent
• Less than 18 years old
• Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarin, warfarin, therapeutic dose of low molecular weight heparins, clopidogrel or analogs, NOAC*s)
• Uncontrolled pulmonary hypertension
• Recent and/or uncontrolled cardiac disease
• Compromised upper airway (e.g., central airway stenosis for any reason such that endobronchial access is considered unsafe)
• Patient is involved in another pulmonary intervention study
• Indication for minimal invasive biopsy of multiple nodules in one procedure
• Endobronchial visible tumor