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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.
Enrollment
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Inclusion criteria
Exclusion criteria
Any contraindication to bronchoscopy, for example:
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:
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
Primary purpose
Allocation
Interventional model
Masking
166 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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