Assessment of Diagnostic Yield Using a Robotic Navigational Bronchoscopy System With CBCT

Inclusion Criteria:

1. Patient is aged 18 years or older at time of consent.

2. Patient is suitable for elective nodule biopsy via bronchoscopy under generalanesthesia per Investigator's discretion.

3. Patient has solid or semi-solid pulmonary nodule(s) of ≥6 mm and ≤3 cm in largestdimension (based on pre-procedure CT scan).

4. Pulmonary nodule(s) intended for biopsy during the study procedure is (are) locatedat least 4 (≥4) airway generations out (trachea = generation 0, e.g. subsegmentalbronchi or beyond) based on pre-procedure CT scan.

5. Patient has a moderate to high risk of lung cancer based on clinical, demographic,and radiologic information or with suspected metastatic disease. High risk formalignancy patients are eligible if a biopsy is required or requested prior tointervention.

6. Patient is willing and able to give written informed consent for ClinicalInvestigation participation.

7. Patient is not legally incapacitated or in a legal/court ordered institution.

Exclusion Criteria:

1. Patient has a lack of fitness or exercise capacity to undergo bronchoscopy undergeneral anesthesia as determined by Investigator prior to procedure.

2. Patient with type 1 pure ground glass opacity target nodule(s) intended for biopsyduring study procedure.

3. Presence of bullae(s) with a size of >1 cm on pre-procedure CT scan located in closeproximity to target nodule(s) and near the planned trajectory of the biopsyinstruments.

4. Presence of mediastinal nodal disease on pre-procedure CT or PET-CT scan.

5. Patient with American Society of Anesthesiologists Classification (ASA) ≥4.

6. Patient underwent a pneumonectomy.

7. Any invasive concomitant procedure (outside of lymph node staging) not related tothe pulmonary nodule(s) or suspected disease state.

8. Female patient of child-bearing potential who is unable to take adequatecontraceptive precautions or is known to be pregnant, and/or breast feeding.

9. Patient has a documented medical history of uncorrectable coagulopathy, bleeding, orplatelet disorder.

10. Patient is taking antiplatelet or anticoagulant medications that cannot be stoppedper standard practice.

11. Patient is currently participating or has participated in another ClinicalInvestigation within the past 30 days, such as interventional trials or trials withexperimental agents or agents of unknown risk, that may affect the endpoints of thisClinical Investigation.

12. Investigator, in their professional opinion, has decided that it is in the patient'sbest interest to not participate in the Clinical Investigation.

13. Patient is not willing to comply with post study procedure participationrequirements.