Given Imaging initiates COLON 2 PillCam study towards FDA approval

June 7, 2011
Yoqneam, Israel--The first PillCam COLON 2 medical study was initiated by Given Imaging to support the Company's planned submission to the U.S. FDA.

Yoqneam, Israel--The first PillCam COLON 2 double-blind, multi-center medical study was initiated by Given Imaging, a pioneer in gastrointestinal (GI) medical devices and capsule endoscopy. The imaging study will support the Company's planned 510(k) submission to the U.S. Food and Drug Administration (FDA). Seventeen sites will enroll a total of 800 patients, aged 50-75 years, who are at average risk for colonic polyps and comprise the normal screening population.

"While colonoscopy remains the most effective test for colorectal cancer screening, not everyone is willing to undergo colonoscopy. Only half of eligible Americans have had a screening test, so we welcome additional tools that can help us increase compliance and lower the incidence of colorectal cancer," said Douglas Rex, MD, Distinguished Professor of Medicine and Chancellor's Professor, Indiana University School of Medicine and Director of Endoscopy, Indiana University Hospital." Aspects of PillCam that are attractive include that it's less invasive, detects polyps better than some of the alternative colonoscopy tests and does not require either sedation or a driver to accompany the patient."

In the double-blind study, PillCam COLON 2 capsule endoscopy will be compared to optical colonoscopy with a primary endpoint of identifying patients with polyps greater than or equal to six millimeters (6 mm) in size and a secondary endpoint of identifying patients with polyps greater than or equal to 10 millimeters (10 mm) in size. Patients first will undergo the PillCam COLON 2 capsule endoscopy procedure, with results sent to a central reading facility for review. Patients will return to their trial site within four to six weeks for a colonoscopy procedure. After the physician performs the colonoscopy, while the patient is still sedated, the PillCam COLON capsule endoscopy findings will be revealed, and the physician will be able to compare results to ensure all polyps were detected and removed.

"We are excited to begin the PillCam COLON 2 pivotal trial as we believe that this product will benefit the approximately fifty percent of Americans who should be getting screened for colon cancer but who are unwilling or unable to undergo colonoscopy. This study is designed to provide the data necessary to demonstrate the efficacy of PillCam COLON 2 as an additional tool in helping GI physicians identify colon polyps," said Homi Shamir, President and Chief Executive Officer, Given Imaging Ltd. "PillCam COLON 2 incorporates next-generation PillCam Platform technology, which is being used in Europe and is incorporated into the PillCam ESO 3 video capsule, which was recently cleared by the FDA for visualizing the esophagus."

PillCam COLON 2 video capsules feature bi-directional communications between the capsule and the DataRecorder 3, and an Adaptive Frame Rate (AFR), which adjusts the image capture rate from 4 frames per second (fps) to 35 fps, based on capsule movement. PillCam COLON 2 received the CE Mark in September 2009 and is commercially available throughout Europe, Latin America, Canada, Australia and parts of Asia. More than 2,000 patients have undergone PillCam COLON capsule endoscopy.

SOURCE: Given Imaging;

Posted by:Gail OvertonSubscribe now to Laser Focus World magazine; It’s free! Follow us on TwitterFollow OptoIQ on your iPhone. Download the free App here

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