Check-Cap (NASDAQ:CHEK) initiated its U.S. pivotal trial of C-Scan to detect polyps before they become colorectal cancer at the Mayo Clinic in Rochester, Minn.
The company has obtained Institutional review board 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 Mayo.
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 aged 50-to-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 that will compare the performance of C-Scan to traditional colonoscopy, using sensitivity and specificity measures and will enroll approximately 800 subjects.
In a statement, Alex Ovadia, CEO of Check-Cap, said the company has established a supply and distribution infrastructure and process of the C-Scan and the plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during the fourth quarter of 2022.
“We believe Check-Cap has the potential to reach those who are deterred by colonoscopy and to help improve colon cancer screening through a patient-friendly solution without the need of bowel cleaning, sedation, and fasting,” he added.