Check-Cap Ltd., a clinical stage medical diagnostics company advancing the development of C-Scan, the first and only patient-friendly, preparation-free screening test to detect polyps before they may transform into colorectal cancer (CRC), today 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.
“We are excited to announce the accomplishment of this important milestone in our path to demonstrate the potential of C-Scan to detect colorectal polyps before they may turn into cancer in the average-risk population,” said Alex Ovadia, chief executive officer of Check-Cap. “We are pleased to have engaged with expert gastroenterologists at Mayo Clinic and continue to advance the participation of additional experienced clinical trial centers in this study. We have established a supply and distribution infrastructure and process of the C-Scan and our plan is to complete the calibration portion of the trial and begin the second statistically powered portion of the study during Q4 2022.”
Mr. Ovadia continued, “Detecting precancerous polyps is needed to effectively prevent colorectal cancer. However, the acceptance of the colonoscopy procedure is low, in part due to the invasiveness of the procedure and bowel cleansing. 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.”
The U.S. pivotal study 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. Additional information about the trial (NCT05271656) can be found here.