The medical device start-up Check-Cap, which has developed an X-ray capsule which performs screening test to detect polyps in the colon, announced the initiation of U.S. pivotal trial. The trial was delayed for over a year due to the COVID-19 crisis. At the completeness of this trial and based on the result, the company will file a request to obtain FDA clearance for its innovative C-Scan® system, intended to be the first and only patient-friendly replacement for traditional Colonoscopy test.
The trial will be conducted at the Mayo Clinic Medical Center in Rochester Minnesota, as well as in other medical centers. Mayo Clinic is one of the most respected academic medical centers in the U.S. and around the world, and is in collaboration with Check-Cap for several years.
The trial will include approximately 1,000 subjects ages 50-75 and will be conducted at up to 15 clinical centers in the U.S. The trial is composed of two phases; the first phase will be served as additional calibration of C-Scan for the average risk U.S. population and will enroll up to 200 subjects. The second phase consists of a statistically powered, randomized study which will compare the performance of the system to traditional colonoscopy and will enroll approximately 800 subjects. Elizabeth Rajan, M.D., gastroenterologist, and professor of medicine at Mayo Clinic, will be the principal investigator of the study at this site.
Check-Cap, located in Isfiya near Haifa, Israel, develops an ingestible capsule-based system for preparation-free colorectal cancer screening. The C-Scan utilizes ultra-low dose X-ray and an wireless communication sub-system. The capsule is used to create a 3D map of the inner lining of the colon, which allows physicians to look for polyps and other abnormalities. C-Scan is non-invasive and requires no preparation or sedation, allowing the patients to continue their daily routine with no interruption as the capsule is propelled through the gastrointestinal tract by natural motility.
“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.”