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