Gastrointestinal (GI) malignancies are the most common cause of cancer in the world. Of the 10.8 million people in the world each year who develop cancer, approximately 3.3 million have GI malignancies. Until recently, the only sections of the GI tract that could be imaged were the esophagus, stomach and colon through traditional endoscopy. Initial segments of the small bowel were imaged using techniques such as push enteroscopy or radioactive imaging techniques, but these methods present significant discomfort to the patients, costly, or lack sensitivity. Capsule endoscopy (CE) is a new technique that is changing the landscape of GI endoscopic diagnosis. CE is a widely acclaimed breakthrough in GI, especially small bowel imaging. However, current CE video display/analysis software (SW) is falling far behind. It has limitations including lengthy video viewing and interpreting time (e.g. ~2 hours) and is difficult in analyzing (e.g. visualizing) findings. These SW issues have incurred considerable amount of costs to patients, and need to be addressed urgently. To address this problem, together with our collaborators, we propose to develop a novel software system to fully automate the video review process and achieve comprehensive and accurate disease analysis. The proposed software system will have the following clinic impact and significance: 3/4 Fully automated and efficient disease detection and classification from CE videos;3/4 Comprehensive visualization or analysis tool for more accurate disease diagnosis;3/4 No more missing GI disorder areas from the review process;3/4 A low cost SW system for better mass acceptance and effective disease prevention;and 3/4 Modular, expandable, and scalable technology. The proprietary software modular (functionally) technology developed can be easily applied to existing diagnosis instruments. The Millennium Research Group predicted the capsule endoscopy market to generate more than $180 million in 2009 in the United States alone - up from just $40 million in 2004. The predicted CAGR is 35.1% during 2008 - 2015. According to Given Imaging Ltd., more than one million patients worldwide have gone through capsule endoscopy procedure using their PillCam capsules. Capsule endoscopy is a rapidly-growing multi-billion dollar market (predicted to reach billion dollar mark in 2015 worldwide). The commercialization potential of the proposed software system and technology is significant.

Public Health Relevance

The software system and technology developed under this SBIR project will provide great benefit to GI patients by providing cost saving and highly accurate GI tract disease finding and analysis software platform. The proposed software will transform the current manual review method into a fully automatic process. With the extended capability over current endoscopes, the proposed SW system is expected to have a reasonably large market share of this 10 billion dollar industry. Other medical areas benefitting from this research include bronchoscopy, colonoscopy, enteroscopy, cystoscopy, laparoscopy, and capsule endoscope. Non-medical fields to benefit this technology include commercial perimeter surveillance, and water and gas pipe inspection - another multi-billion market.

National Institute of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
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Special Emphasis Panel (ZRG1-SBIB-Q (80))
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Densmore, Christine L
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Xyken, LLC
United States
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