April 15, 2019 — Check-Cap Ltd. has initiated its U.S. pilot study of the C-Scan system for prevention of colorectal cancer through detection of precancerous polyps, following Institutional Review Board (IRB) approval and full Investigational Device Exemption (IDE) application approval by the U.S. Food and Drug Administration (FDA). The first patients have ingested C-Scan, a preparation-free capsule, at the New York University School of Medicine.
"We are pleased to participate in this pilot study of C-Scan, a preparation-free capsule-based system for the prevention of colorectal cancer being tested in the U.S.," noted Seth A. Gross, M.D., gastroenterologist and associate professor of medicine, NYU Langone Health. "Unfortunately, colorectal cancer remains the second-leading cause of cancer death in the U.S. But we know that with the utilization of colorectal cancer screening, we can reduce the incidence and mortality rates related to this disease. The potential addition of a new screening option that is capsule-based and does not require a bowel prep offers the promise of increasing our screening rates. We are looking to the results of this study and the potential for an effective new screening option for the prevention and early detection of colorectal cancer."
The single-arm pilot study (NCT03735407) will enroll up to 45 subjects considered to be of average risk for polyps and colon cancer. The study is evaluating the safety, usability and subject compliance of the C-Scan system.
It is estimated that in 2018, there were approximately 881,000 deaths and more than 1.8 million new cases of colorectal cancer (CRC) worldwide. CRC typically begins as precancerous polyps or abnormal growths in the colon or rectum, which can be present for up to 10 years before developing into invasive cancer. As a result, screening for precancerous polyps is the most direct method for CRC prevention. Despite evidence that standard screening can prevent CRC, adherence remains low due to the required bowel preparation, invasiveness, and in some communities, limited access.
The C-Scan system utilizes an ultra-low dose X-ray capsule, an integrated positioning, control and recording system, as well as proprietary software to generate a 3-D map of the inner lining of the colon. C-Scan is non-invasive and requires no preparation or sedation, allowing the patient to continue their daily routine with no interruption as the capsule is propelled through the gastrointestinal tract by natural motility.
For more information: www.check-cap.com