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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
166
The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Duke University
Durham, North Carolina, United States
Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, United States
Proportion of biopsies yielding tissue sufficient for diagnosis
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.
Time frame: Up to 1 year
Procedure planning time
The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported
Time frame: Up to 1 year
Nodule access time
The time from the start of navigation until the sheath has been placed at the first biopsy target.
Time frame: Up to 1 year
Fluoroscopy time
The total fluoroscopy time from the start of fused-fluoroscopic navigational guidance to the time the devices are removed from the point of entry.
Time frame: Up to 1 year
Patient registration time
The total time it takes to correlate the patient's position via fluoroscopy with the navigational guidance system.
Time frame: Up to 1 year
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
ThoraxKlinik
Heidelberg, Germany
Hong Kong Sanatorium & Hospital
Hong Kong, Hong Kong