Evaluation of the Archimedes™ System for Transparenchymal Nodule Access 2 (EAST2)

  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 Recruiting
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.

United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710

Contact: Momen Wahidi, M.D.

Contact: Moyinoluwa Adetunji    919-684-9139

Principal Investigator: Momen Wahidi, M.D.

United States, Oklahoma
Cancer Treatment Centers of America at Southwestern Regional Medical Center Recruiting
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.

United States, Pennsylvania
Temple University Hospital Recruiting
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

United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030

Contact: Lisa Kopas

Contact: Raquel R Bunge    713-441-3912

Principal Investigator: Lisa Kopas, M.D.

China, Guangdong
The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China

Contact: Shiyue Li, M.D.

Principal Investigator: Shiyue Li, M.D.

China, Shanghai
Shanghai General Hospital Recruiting
Shanghai, Shanghai, China

Contact: Jiayuan Sun, M.D.

Principal Investigator: Jiayuan Sun, M.D.

Germany
ThoraxKlinik Recruiting
Heidelberg, Germany

Contact: Felix Herth, M.D.

Principal Investigator: Felix Herth, M.D.