Check-Cap Ltd. announced the initiation of its U.S. pivotal trial of C-Scan® at Mayo Clinic in Rochester Minnesota. The Company has successfully obtained Institutional review board (IRB) approval for the study and expects to promptly begin patient enrollment. Elizabeth Rajan, M.D., gastroenterologist, and professor of medicine at Mayo Clinic, will be the principal investigator of the study at this site.

The U.S. pivotal study (NCT05271656) is designed to obtain FDA clearance for C-Scan® in the U.S. The study is a two-part open label trial to evaluate the accuracy of C-Scan to identify subjects who are at elevated risk for colon polyps. It is expected to enroll approximately 1,000 subjects ages 50-75 and will be conducted at up to 15 clinical sites in the U.S. The first part of the trial is designed to enable further calibration of C-Scan for the average risk U.S. population and will enroll up to 200 subjects. The second part consists of a statistically powered, randomized study which will compare the performance of C-Scan to traditional colonoscopy, using sensitivity and specificity measures and will enroll approximately 800 subjects.