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Temple University Hospital Participating in New Clinical Trial Evaluating Novel Device to Access and Biopsy Lung Nodules

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Gerard Criner, MD, FACS

Lung cancer is the most common cause of cancer-related deaths in the United States, with approximately 220,000 new cases of lung cancer predicted in 2017, according to the American Cancer Society. Treatment is often more successful when the cancer is detected early. For some patients though, cancer located in the lung may be hard to access due to the nodule’s location and size. 

Temple University Hospital (TUH) is participating in a new phase IV clinical trial utilizing novel technology to access hard to reach areas, including nodules located outside the airway in the periphery of the lungs, to help diagnose potential lung cancer or metastatic disease. TUH is the only hospital on the east coast offering the technology to its patients.

The current standard practice to access a nodule in the lung is to puncture the chest externally or perform surgery to access the nodule for biopsy, both of which can cause complications and require extended recovery time. TUH is offering a less invasive, endoscopic approach using the Archimedes™ System, an image guided navigation system that can access tissue samples in the lungs. The technology features sophisticated software and a set of catheter-based devices.

“This piece of technology will give us the capability to reach hard to access spots in the lungs safely, which traditional technology would not be able to do,” says Gerard Criner, MD, FACS, local principal investigator, Professor and Chair of the Department of Thoracic Medicine and Surgery at the Lewis Katz School of Medicine at Temple University, and Director of the Temple Lung Center. “We will be able to gather a larger tissue sampling which will increase the accuracy of benign or cancerous diagnoses.”

The Evaluation of the Archimedes System for Transparenchymal Nodule Access 2 (EAST 2) clinical trial will evaluate the performance of the Archimedes System in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or disease. 

A preliminary study outside the United States has shown that the use of the Archimedes System increased the diagnostic yield, or likelihood that the procedure would provide the information needed to establish a diagnosis, by 83 – 100 percent compared to the traditional bronchoscopy yield of 67 to 71 percent. 

Archimedes creates a 3D model of a patient’s lungs from computerized tomography (CT) scans to help pulmonologists pinpoint which part of the lung to access during the bronchoscopy. During the procedure, the system provides advanced, real-time images to guide the bronchoscope to the nodule access site.

“We then create a small hole in the airway wall to get to the nodule,” adds Dr. Criner. “This is not possible with the traditional bronchoscopy. We widen the hole using a small balloon and move a sheath through the hole toward the nodule location and take tissue samples.”

The Archimedes System is manufactured by Broncus® Medical, Inc. 

Editor’s Note: Neither Dr. Criner nor any member of his immediate family has financial interest in Broncus Medical, Inc.