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Check-Cap gains IRB approval to initiate US pilot study of C-scan for the detection of precancerous colorectal polyps

Thu, 02/14/2019 - 13:55
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Check-Cap has received Institutional Review Board (IRB) approval from New York University School of Medicine to initiate a U.S. pilot study of the C-Scan system. According to the company, C-Scan is the first and only preparation-free ingestible scanning capsule for the prevention of colorectal cancer (CRC) through the detection of precancerous polyps.

The patient-friendly test has the potential to increase screening adherence and reduce the overall incidence of CRC. The C-Scan system utilises an ultra-low dose X-ray capsule, an integrated positioning, control, and recording system, as well as proprietary software to generate a 3D 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.

"We are excited to receive IRB approval as this important milestone enables Check-Cap to bring the C-Scan system into the clinic in the US," said Alex Ovadia, chief executive officer of Check-Cap. "Following the CE Mark clearance and approval to initiate commercial sales of the C-Scan system in Israel last year, IRB approval is a critical step towards developing clear paths to commercialization in major markets worldwide. We look forward to the initiation of the pilot study evaluating our patient-friendly screening method for colorectal cancer as we aim to increase screening adherence and ultimately decrease the overall incidence for this highly-preventable disease."

The US pilot study (NCT03735407) will be a single-arm study enrolling up to 45 subjects considered to be of average risk for polyps and colon cancer. The study will evaluate the safety, usability, and subject compliance of the C-Scan system. The study will be conducted at New York University School of Medicine.