Given Imaging Announces Another Publication of Controlled Clinical Trial in Peer Reviewed Journal
Publication in Endoscopy adds to the growing number of studies demonstrating the benefits of capsule endoscopy
Sep 26, 2002 - HAMBURG, Germany - Given Imaging (Nasdaq: GIVN) announced today the publication of results of a controlled clinical trial comparing wireless capsule endoscopy with push enteroscopy in chronic gastrointestinal bleeding, published in the September issue of Endoscopy (2002; 34 (9): 685 - 689). The study concludes that the companys M2A capsule endoscope has a significantly superior diagnostic yield when compared to push enteroscopy. The study was conducted by Prof. Christian Ell, head of the Department of Internal Medicine II, Dr. Host Schmidt Hospitals in Wiesbaden, Germany.
"Capsule endoscopy can help reduce the number of diagnostic procedures and will become the initial diagnostic choice in patients with chronic gastrointestinal bleeding and negative upper and lower conventional gastrointestinal endoscopy," said Prof. Ell.
In the trial, 32 patients suffering from chronic gastrointestinal bleeding received complete conventional diagnostic work-ups, push enteroscopy and capsule endoscopy. A total of 92 conventional diagnostic procedures, including small bowel enteroclysis, angiography and scintigraphy, revealed relevant findings, capable of identifying the probable bleeding source, in only five of the 32 patients (16%). Push enteroscopy detected definite bleeding sites in nine of the 32 patients (28%). Using capsule endoscopy, investigators were able to detect definite bleeding sources in 21 of the 32 patients (66%).
Publication of the study follows two studies recently published in peer reviewed publications. A study published in the latest issue of Disease Management (Volume 5, Number 3, 2002) concluded that the M2A capsule endoscope can provide a potential net cost savings through earlier diagnosis of obscure intestinal bleeding. A study published in the latest issue of Gastrointestinal Endoscopy (September 2002, Volume 56, Number 3) concluded that Given Imagings M2A capsule endoscope identified small intestinal bleeding sites beyond the range of push enteroscopy. The study also concluded that capsule endoscopy provides excellent visualization of the small intestine, and is well tolerated and safe.
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