Lung Cancer
Conditions
Brief summary
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.
Interventions
DEVICEArchimedes System
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
Sponsors
Broncus Medical Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21-75 years at screening 2. Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ≥8mm in its largest dimension 3. No known endobronchial tumor 4. Tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a POE. 5. Willing to participate in all aspects of study protocol for duration of study 6. Able to understand study requirements 7. Subject or legally authorized representative signs study-related informed consent document
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of biopsies yielding tissue sufficient for diagnosis | Up to 1 year | The number of nodules with at least one biopsy sufficient for a definitive tissue diagnosis divided by the number of nodules sampled by the Archimedes System. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure planning time | Up to 1 year | The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported |
| Nodule access time | Up to 1 year | The time from the start of navigation until the sheath has been placed at the first biopsy target. |
| Fluoroscopy time | Up to 1 year | The total fluoroscopy time from the start of fused-fluoroscopic navigational guidance to the time the devices are removed from the point of entry. |
| Patient registration time | Up to 1 year | The total time it takes to correlate the patient's position via fluoroscopy with the navigational guidance system. |
Countries
China, Germany, Hong Kong, United States
Outcome results
None listed