Assessment of Tool Placement in Pulmonary Nodule(s) Using a Robotic Navigational Bronchoscopy System

Exclusion Criteria

• •1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by Investigator prior to procedure.
• •2. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsy during study procedure.
• •3. Presence of mediastinal or hilar lymphadenopathy requiring tissue biopsy on pre-procedure CT or positron emission tomography (PET)-CT scan.
• •4. Patient with American Society of Anesthesiologists Classification (ASA) ≥4.
• •5. Patient underwent a pneumonectomy.
• •6. Any invasive concomitant procedure not related to the pulmonary nodule(s) or suspected disease state.
• •7. Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding.
• •8. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder.
• •9. Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice.
• •10. 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.
• •11. Investigator, in their professional opinion, has decided that it is in the patient's best interest to not participate in the Clinical Investigation.
• •12. Patient is not willing to comply with post study procedure participation requirements.