YOQNEAM, Israel - Given Imaging Ltd. (NASDAQ: GIVN) has announced highlights of clinical data presented on PillCam Capsule Endoscopy at the Annual Scientific Meeting of the American College of Gastroenterology which took place in Las Vegas, Nevada Oct. 20-25. Noteworthy presentations included data from the first U.S. trial studying PillCam COLON as well as a study validating a new index to measure small bowel mucosal activity.

PillCam COLON

"Capsule Colonoscopy - An Interim Report of a Pilot Three Arm, Blinded Trial of Capsule Colonoscopy, Virtual Colonoscopy and Colonoscopy"


Led by Blair Lewis, M.D., Mount Sinai Medical Center, Douglas Rex, M.D., Indiana University Hospital, and David Lieberman, M.D., Oregon Health and Science University, the study evaluated 25 patients over the age of 50 who had not had a colonoscopy within the past five years or a family history of colon cancer. The patients underwent PillCam COLON followed by virtual colonoscopy and standard colonoscopy three weeks later. Investigators were blinded to the results. Of the 25 patients, 44% (n=11) had significant findings defined as at least one polyp measuring 6 mm or more than three polyps of any size, confirmed by standard colonoscopy (blinded or unblinded). PillCam COLON identified 64% or (n=7) of the significant polyps, virtual colonoscopy identified 55% (n=6) and blinded standard colonoscopy 82% (n=9). The investigators concluded that PillCam COLON is a promising new technology for visualizing the colon for polyps.

"PillCam COLON in Comparison with Standard Colonoscopy in the Detection of Polyps- Results from the First Prospective Multi-Center Study"

A total of 91 individuals were enrolled in three Israeli centers, Rambam Medical Center, Hillel-Yaffe Medical Center and Bikur Holim Hospital; the results were evaluable in 84 cases. The patients all underwent capsule colonoscopy with the PillCam COLON and were all scheduled for traditional colonoscopies later in the day. Polyps of any size were found in 45 patients by either of the screening methods. PillCam COLON identified 76% (n=34) compared to 80% (n=36) by colonoscopy. Out of the 84 patients, approximately 24% (n=20) had significant findings, defined as at least one polyp measuring 6 mm or three or more polyps of any size. Of these, PillCam COLON identified 14 (70%) and colonoscopy 16 (80%). There were no adverse events reported except in one patient who had severe abdominal pain immediately following traditional colonoscopy. The colonic preparation was well tolerated in all cases.

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