Purpose
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.
| 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, Massachusetts | |
| Beth Israel Deaconess Medical Center | Completed |
| Boston, Massachusetts, United States, 02215
Contact: Adnan Majid, M.D. 617-632-8386 Contact: Alexis Agnew 617-632-8386 Principal Investigator: Adnan Majid, M.D. |
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| United States, North Carolina | |
| Duke University | Completed |
| Durham, North Carolina, United States, 27710
Contact: Momen Wahidi, M.D. Contact: Moyinoluwa Adetunji 919-684-9139 Principal Investigator: Momen Wahidi, M.D. |
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| United States, Oklahoma | |
| Cancer Treatment Centers of America at Southwestern Regional Medical Center | Completed |
| 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. |
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| United States, Pennsylvania | |
| Temple University Hospital | Completed |
| Philadelphia, Pennsylvania, United States, 19140
Contact: Gerard J. Criner, MD 215-707-2000 Contact: JiJi Thomas (215) 707-2000 Principal Investigator: Gerard J. Criner, MD |
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| University of Pennsylvania | Completed |
| Philadelphia, Pennsylvania, United States, 19104
Contact: Kristina Maletteri krisma@pennmedicine.upenn.edu Principal Investigator: Anil Vachani, M.D. |
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| United States, Texas | |
| Houston Methodist Hospital | Completed |
| Houston, Texas, United States, 77030
Contact: Lisa Kopas Contact: Raquel R Bunge 713-441-3912 Principal Investigator: Lisa Kopas, M.D. |
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| China, Guangdong | |
| The First Affiliated Hospital of Guangzhou Medical University | Completed |
| Guangzhou, Guangdong, China
Contact: Shiyue Li, M.D. Principal Investigator: Shiyue Li, M.D. |
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| China, Shanghai | |
| Shanghai General Hospital | Completed |
| Shanghai, Shanghai, China
Contact: Jiayuan Sun, M.D. Principal Investigator: Jiayuan Sun, M.D. |
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| Germany | |
| ThoraxKlinik | Completed |
| Heidelberg, Germany
Contact: Felix Herth, M.D. Principal Investigator: Felix Herth, M.D. |
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