Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2

Inclusion criteria

• Age 21-75 years at screening
• Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ≥8mm in its largest dimension
• No known endobronchial tumor
• Tumor located anywhere in parenchymal tissue >1 cm from pleura and accessible bronchoscopically through a POE.
• Willing to participate in all aspects of study protocol for duration of study
• Able to understand study requirements
• Subject or legally authorized representative signs study-related informed consent document

Exclusion criteria

• Any contraindication to bronchoscopy, for example:

• Untreatable life-threatening arrhythmias
• Inability to adequately oxygenate the patient during the procedure
• Acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated)
• Recent myocardial infarction
• Previously diagnosed high-grade tracheal obstruction
• Uncorrectable coagulopathy
• Known coagulopathy
• Platelet dysfunction or platelet count < 100 x 103 cells/mm3
• History of major bleeding with bronchoscopy
• Suspected pulmonary hypertension: additional testing required, such as echocardiogram
• Moderate-to-severe pulmonary fibrosis
• Severe emphysema or COPD: additional testing and PI consent is required
• Bullae >5 cm located in vicinity of target nodule or tunnel
• Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:

• ASA class > 3
• > stage 3 heart failure
• severe cachexia
• severe respiratory insufficiency or hypoxia
• Ongoing systemic infection
• Contraindication to general anesthesia
• Inability to stop anticoagulants (e.g., heparin, Warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure
• Participation in any other study in last 30 days
• Prior thoracic surgery on the same side of the lung as the SPN.
• 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.
• Life expectancy of less than one year.
• Scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy
• Prior radiation therapy treatment in the target lobe