Given Imaging Ltd. (NASDAQ/exchange>: GIVN) today announced a new study showing that PillCam® ESO accurately identifies and allows the physician to classify high-risk emergency room patients with upper gastrointestinal bleeding (UGIB), leading to rapid therapeutic intervention. Among patients classified through capsule endoscopy, time to endoscopy was significantly shorter (2.5 hours v. 8.9 hours) among those with positive signs of bleeding, when compared to patients undergoing standard clinical assessment. Dr. Syed Hussain presented the results of the study at the annual American College of Gastroenterology Conference, on October 26, 2009, in San Diego, CA, at the Outcomes Plenary Session and accepted the Astra-Zeneca Senior Fellow Award on behalf of the investigators at New York Hospital-Queens, Weill-Cornell Medical College.
"Upper GI bleeding remains a serious condition, but studies have shown that we can reduce risk by accelerating the time to treatment," said Moshe Rubin, M.D., the principal investigator and Director of Gastroenterology at New York Hospital-Queens. "Our pilot study demonstrates that real-time viewing with capsule endoscopy in the Emergency Room enables rapid identification of high-risk patients who benefit most from urgent endoscopy to control their bleeding." Further studies with a larger group of patients are planned to validate the findings of this initial study in which PillCam proved to be a valuable tool in the diagnosis and treatment of acute upper gastrointestinal bleeding.
Twenty-four ER patients with a history of upper GI bleeding (UGIB) were randomized to undergo live PillCam capsule endoscopy or standard clinical assessment, consisting of clinical judgment and objective scoring systems. In the capsule endoscopy cohort, patient studies were read in real-time at the patient's bedside and later reviewed after the video was downloaded. In the capsule endoscopy cohort:
-- Seven of 12 showed positive signs of bleeding -- Four patients' actual lesions were visualized in real time -- Two patients' lesions were visualized at download -- Five of 12 showed no signs of bleeding -- Four patients had no stigmata at EGD following the capsule endoscopy -- One patient did not undergo EGD due to co-morbidities
The study included 14 males and 10 females, with an average age of 66 years.