Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2 (EAST2)
Purpose
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.
| Current Primary Outcome Measures | 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. |
| Current Secondary Outcome Measures | • Procedure planning time
The time from selecting the patient CT until the tunnel path has been selected, reviewed and exported • Nodule access time The time from the start of navigation until the sheath has been placed at the first biopsy target. • 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. • Patient registration time The total time it takes to correlate the patient’s position via fluoroscopy with the navigational guidance system. |
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02867371
Locations
| United States, Oklahoma | |
| Cancer Treatment Centers of America at Southwestern Regional Medical Center
Tulsa, Oklahoma, United States, 74133 Contact: Daniel Nader, D.O. 918-286-5000 Contact: Faye Biggs (918) 286-5000 Principal Investigator: Daniel Nader, D.O. |
Recruiting |
| United States, Pennsylvania | |
| Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140 Contact: Gerard J. Criner, MD 215-717-2000 Contact: JiJi Thomas (215) 717-2000 Principal Investigator: Gerard J. Criner, MD |
Recruiting |
| China, Guangdong | |
| The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China Contact: Shiyue Li, M.D. Principal Investigator: Shiyue Li, M.D. |
Recruiting |
| China, Shanghai | |
| Shanghai General Hospital
Shanghai, Shanghai, China Contact: Jiayuan Sun, M.D. Principal Investigator: Jiayuan Sun, M.D. |
Recruiting |
| Germany | |
| ThoraxKlinik
Heidelberg, Germany Contact: Felix Herth, M.D. Principal Investigator: Felix Herth, M.D. |
Recruiting |