SBIR-STTR Award

Colon cancer is a leading cause of cancer death in the United States and overseas. Colonoscopy is the preferred screening method at an estimated annual cost of over $20 billion in the US. Unfortunately, many lesions are missed because pre-cancerous growths remain hidden from view behind folds and flexures of the colon. Current methods of increasing the field of view are ineffective and some are very expensive, which hampers adoption of these methods into clinical practice. A proprietary dual-view imaging method has been developed that illuminates and images forward as well as backwards in 360 degrees, and produces a single image. A proof of concept prototype has been successfully developed, but is too large to be used with a colonoscopy. Omniscient LLC will license the method from the University of Arizona and construct a dual-view optical probe that is small enough to be passed through the biopsy channel of a standard colonoscopy. Omniscient LLC will develop software which combines both views in a single video display and optimize image quality. The probe will be tested in standard colonoscopy models with simulated polyps in areas that are easy to see as well as those hidden from forward view. The probe will be passed through the biopsy channel of the standard colonoscopy and its performance will be compared to that of the standard colonoscopy alone. Successful completion of this Phase I STTR project will lead to a dual-view probe which can be used with standard colonoscopy and is suitable for clinical testing.

Public Health Relevance Statement:


Public Health Relevance:
Colonoscopy is a common cancer screening procedure that is far from perfect and one of its major flaws is that the physician is unable to view large areas of the colon hidden behind folds, which leads to missed pre-cancerous growths and the unexpected, early development of cancer. Omniscient LLC will license a proprietary method of seeing forwards and backwards in a single image, construct and test a probe that is small enough to be passed through the instrument channel in endoscopes. When used in patients, this will allow the entire colon to be seen, prevent cancer and reduce the number of procedures a person needs.

NIH Spending Category:
Aging; Bioengineering; Cancer; Colo-Rectal Cancer; Digestive Diseases; Prevention

Project Terms:
Address; Adoption; Area; Arizona; base; Biopsy; Caliber; Cancer Etiology; Cancerous; Cessation of life; clinical efficacy; clinical practice; Clinical Research; Colon; Colon Carcinoma; Colonoscopes; Colonoscopy; Color; contrast imaging; cost; cost effective; Detection; Development; Devices; Endoscopes; Equipment; Excision; Goals; Growth; Image; imaging modality; imaging probe; improved; Incidence; innovation; instrument; Label; Lead; Legal patent; Lesion; Licensing; Light; Lighting; Malignant Neoplasms; Marketing; men; Methods; miniaturize; Modeling; novel; Optics; Patients; Performance; Persons; Phase; Physicians; Polyps; prevent; Procedures; prototype; public health relevance; Research; research clinical testing; screening; Screening procedure; Small Business Technology Transfer Research; software development; Surface; System; Techniques; Technology; Testing; United States; Universities; Woman

An estimated 16 million colonoscopies are performed annually in the US at a cost of about $24B, however current colonoscopes with forward vision fail to detect 25-40% of precancerous polyps. Over 70% of the missed polyps are located on or behind numerous folds in the colon where they are hidden from the sight of a forward-view colonoscope. In this research proposal, we propose to complete our development of an imaging system that provides unprecedented forward as well as 360-degree reverse views in a single image. In our STTR Phase I study, we successfully developed our second prototype and re-confirmed the substantial superiority of our Dual View technique over standard colonoscopy. The technology was invented by the co- founders of the company, a gastroenterologist and an optical scientist at the University of Arizona and has been licensed by Omniscient. Device development was guided by feedback from endoscopists and industry executives. In this proposal we will further miniaturize the device, improve resolution and build an imaging system that can be integrated with any commercial endoscopy platform. Our market research indicated an overwhelming need for an `add-on' that can be used in conjunction with existing endoscopes, rather than a totally new endoscope. In collaboration with the University of Arizona, Omniscient will develop an imaging system where a capsule with a diameter of about 4 mm can be attached to the tip of any existing colonoscope to provide endoscopists with unprecedented forward and 360-degree backwards views in a single display monitor. This reusable endoscopic accessory will avoid the need and expense of replacing an endoscopy platform, allow our product to be highly cost-effective and permit the endoscopist to continue to use their preferred endoscope. We have assembled a multi-disciplinary team and formed collaborations with industry partners in lens fabrication, camera manufacturing and medical device marketing to facilitate the successful development and market launch of our product. We will continue to use end-use and market feedback to fine- tune the development of this imaging system while following regulatory standards. Omniscient has contacted the US Food and Drug Administration and will complete in-vivo colonoscopy studies in pigs, as well as reprocessability tests needed for regulatory approval. In the latter stages of this research, the company will begin organizing multi-center human studies that should lead to product launch following regulatory approval. Our extraordinary technology will transform the way colonoscopy is performed. It will greatly enhance polyp detection, prevent more cancers and reduce the national expenditure for colonoscopy.

Public Health Relevance Statement:
Project Narrative Colonoscopy is the preferred screening procedure to prevent colon cancer, but is far from perfect as current endoscopes fail to see behind folds and around corners, leading to missed lesions and unexpected cancers. We will complete the development of an affordable, reusable, Dual-View device that can be used with any existing endoscopes to provide forward and backwards views in the same image. We will evaluate it in the pig colon and assess its reusability to meet FDA requirements for regulatory approval.

Project Terms:
Arizona; biomaterial compatibility; Caliber; capsule; clinical implementation; Clinical Trials; Collaborations; Colon; colon cancer prevention; colon cancer screening; Colon Carcinoma; Colonoscopes; Colonoscopy; Computer software; cost; cost effective; Custom; design; Detection; Development; Device or Instrument Development; Devices; Disinfection; Distal; Early Diagnosis; Endoscopes; Endoscopy; Expenditure; Family suidae; Feedback; flexibility; Gastroenterologist; Goals; Grant; Human; Image; imaging system; improved; in vivo; Industry; industry partner; International; Lead; Legal patent; lens; Lesion; Lighting; Link; Malignant Neoplasms; Market Research; Marketing; Medical Device; Methods; Mind; miniaturize; models and simulation; Monitor; multidisciplinary; Neoplasms; Optics; Performance; Phase; phase 1 study; Polyps; Positioning Attribute; Precancerous Polyp; Premalignant; prevent; Procedures; product development; prototype; Research; Research Proposals; Resolution; Safety; Scientist; Screening procedure; sensor; Small Business Technology Transfer Research; System; Techniques; Technology; Testing; Thumb structure; Tissues; United States Food and Drug Administration; Universities; Vision