Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs. This study is being conducted to confirm the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. Navigation to and sampling of the patient's lung cancer tumor is conducted.
• 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