A prospective, dual-arm, interventional study. Prospective collection of consecutive patients undergoing a biopsy procedure with the Ion Endoluminal system with CBCT imaging, and comparing these results with the prospectively collected cohort of CBCT-navigation bronchoscopy procedures performed at Radboudumc.
Intervention
Patients with peripheral pulmonary nodule(s) measuring >=6 mm and <=3 cm in largest dimension (based on pre-procedure CT scan) who are indicated to undergo bronchoscopic biopsy for lung nodule(s) of unknown etiology, suspicious for primary lung cancer or metastatic disease will undergo Robotic Navigational Bronchoscopy.
Key outcome parameters
Diagnostic yield of sample(s) obtained (post learning curve)
Sensitivity CUSUM analysis (learning curve)
Sensitivity for malignancy of sample(s) obtained
Rate of achieving biopsy tool position within the targeted nodule(s) as confirmed by CBCT 3D imaging.
Key inclusion criteria
Patient is aged 18 years or older at time of consent.
Patient is suitable for elective nodule biopsy via bronchoscopy under general anesthesia per investigator's discretion.
Patient has a solid or semi-solid pulmonary nodule(s) of >= 6 mm and <= 3 cm in largest dimension (based on pre-procedure CT scan)
Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 (>=4) airway generations out (trachea = generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan.
Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. High risk for malignancy patients are eligible if a biopsy is required or requested prior to intervention.
Patient is willing and able to give written informed consent for investigation participation.
Patient is not legally incapacitated or in legal/court ordered institution.
Key exclusion criteria
Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
Presence of bullae(s) with a size of >1 cm on pre-procedure CT scan located in close proximity to target nodule(s) and near the planned trajectory of the biopsy instruments.
Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.
Patient with ASA >=4.
Patient underwent a pneumonectomy.
Any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule(s) or suspected disease state.
Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation.
Investigator, in their professional opinion, has decided that it is in the patient’s best interest to not participate in the Clinical Investigation.
Patient is not willing to comply with post study procedure participation requirements.
