Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Exclusion Criteria

• •1. Any contraindication to bronchoscopy, for example:
• •1. Untreatable life-threatening arrhythmias
• •2. Inability to adequately oxygenate the patient during the procedure
• •3. Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
• •4. Recent myocardial infarction
• •5. Previously diagnosed high-grade tracheal obstruction
• •6. Uncorrectable coagulopathy
• •2. Known coagulopathy
• •3. Platelet dysfunction or platelet count \< 100 x 103 cells/mm3
• •4. History of major bleeding with bronchoscopy
• •5. Suspected pulmonary hypertension: additional testing required, such as echocardiogram
• •6. Moderate-to-severe pulmonary fibrosis
• •7. Severe emphysema or COPD: additional testing and PI consent is required
• •8. Bullae \>5 cm located in vicinity of target nodule or tunnel
• •9. Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:
• •1. ASA class \> 3
• •2. \> stage 3 heart failure
• •3. severe cachexia
• •4. severe respiratory insufficiency or hypoxia
• •10. Ongoing systemic infection
• •11. Contraindication to general anesthesia
• •12. Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
• •13. Participation in any other study in last 30 days
• •14. Prior thoracic surgery on the same side of the lung as the SPN.
• •15. Breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study.
• •16. Life expectancy of less than one year.
• •17. Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
• •18. Prior radiation therapy treatment in the target lobe