Check-Cap, a clinical-stage medical diagnostics-maker, has secured conditional approval from the US Food and Drug Administration (FDA) for its investigational device exemption (IDE) application to begin a pilot study for C-Scan system.
FDA’s conditional approval for the IDE requires Check-Cap to provide additional information to the FDA and the company can start patient enroll immediately after receiving approval by the study site’s Institutional Review Board (IRB).
The pilot study in the US will be a single-arm study enrolling subjects considered to be of average risk for polyps and colon cancer. The study will find the safety, usability and subject compliance of the C-Scan system.
C-Scan is an ingestible capsule-based device which is claimed to be a preparation-free colorectal cancer screening.
The system uses ultra-low dose X-ray and wireless communication technologies, where the capsule generates information on the contours of the inside of the colon as it passes naturally. This information is used to create a 3D map of the colon, which allows physicians to look for polyps and other abnormalities.
The company claims that C-Scan can remove the frequently-cited barriers, such as laxative bowel preparation, invasiveness and sedation.
Check-Cap CEO Alex Ovadia said: “We are pleased to have received FDA approval of our IDE application, and we look forward to initiating our pilot study of the C-Scan system. This is a significant milestone for our company as we work to advance the clinical development of our novel technology in the US.
“As the first and only preparation-free capsule based screening method for colorectal cancer prevention through precancerous polyp detection, we believe C-Scan can significantly increase screening adherence, resulting in improved patient outcomes and significant savings to the healthcare system. We look forward to results from this first US study.”
In October, the company made IDE submission to the FDA for its C-Scan system.
It is estimated that in this year, there were nearly 881,000 deaths and more than 1.8 million new cases of colorectal cancer (CRC) worldwide. Typically, CRC starts as a precancerous polyps or abnormal growths in the colon or rectum, which can be present for up to 10 years before developing into invasive cancer, said Check-Cap.
As a result, screening for precancerous polyps has been taken up as the most direct method to prevent CRC. In spite of evidence that standard screening can prevent CRC, adherence is low due to the required bowel preparation, invasiveness and in some communities, limited access.