Check-Cap Prep-Less Colon Imaging Capsule Proven Safe and Feasible According to Data Presented at Digestive Disease Week® 2014
ISFIYA, Israel, May 8, 2014 /PRNewswire/ — A new investigational imaging capsule has the potential to safely produce high-resolution images of the colon without requiring patients to go through the bowel cleansing process beforehand, according to data presented at a research forum during the Digestive Disease Week® (DDW®) 2014 annual meeting which took place this week in Chicago.
“Fewer than 20% of Europeans and 55% of Americans in the target population for colon screening actually undergo colonoscopies according to guidelines and one of the major hurdles is the burdensome preparation process required to thoroughly cleanse the bowel,” said lead investigator Nadir Arber, M.D., Director, Integrated Cancer Prevention Center at Tel Aviv Sourasky Medical Center in Israel, and President of the Israeli Society of Gastroenterology. “There is a critical need for increasing colon cancer screening compliance and a prep-free alternative could help overcome this significant hurdle.”
For this 10-case study (M=7, F=3) the Check-Cap high-resolution colon imaging capsule was ingested. Developed by Israeli medical device company Check-Cap, Ltd., the capsules were tracked during the passage using radio frequency telemetry and an electromagnetic localization system (ELS). The capsules also perform low-dose high resolution x-ray scans when movement in the colon is detected and transmit the imaging data to an external recorder unit worn by the patient.
The data obtained from this study and presented by Dr. Arber demonstrated the safety and proof of concept of the Check-Cap Imaging System. All patients in the study were able to ingest and naturally excrete the capsule without discomfort or side effects. In addition, using ultra-low dose equivalent to a dental x-ray or a flight from New York to London, intra colonic 3D circumferential imaging was achieved in the prep-less colon of human subjects with no prior cleansing. A multi-center study is planned to further study the clinical efficacy of the Check-Cap Imaging System for the detection of pre-cancerous polyps.
Check-Cap, Ltd. did not provide financial support for the above scientific sessions and did not influence the content in any way. However, research presented within these scientific sessions may have been supported by Check-Cap, Ltd.
Digestive Disease Week® (DDW®) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 3 – 6, 2014, at McCormick Place, Chicago, Illinois. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.
About Check-Cap, Ltd.
Check-Cap is a medical diagnostics company focused on the development of gastrointestinal imaging devices. The company’s lead product is an endoscopy capsule that utilizes proprietary, ultra-low-energy X-ray-based measurement technology to safely generate high-resolution, 3-dimensional imagery of the colon without cleansing or other aggressive bowel preparation. This patient-friendly solution is designed to increase compliance with screening recommendations. The Check-Cap System is not cleared for marketing in the U.S.
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SOURCE Check-Cap, Ltd.