CLINICAL DEVELOPMENT
Check-Cap is currently conducting a pivotal study in the U.S., to evaluate the accuracy of C-Scan to identify subjects who are at elevated risk for colon polyps. The trial is designed to obtain FDA approval for C-Scan in the U.S.
The study is a two-part open label trial, and it is expected to enroll approximately 950 subjects ages 50-75. It will be conducted at up to 15 clinical sites in the U.S, and additional sites outside of the U.S.
The first part of the trial (up to 200 subjects) is designed to enable further calibration of C-Scan for the average risk U.S. population.
The second part consists of a statistically powered study which will compare the performance of C-Scan to traditional colonoscopy, using sensitivity and specificity measures.
The C-Scan® System is not approved in the United States and is currently an investigational device there. It is not available for sale in any jurisdiction. This website is not intended to provide medical advice for patients or healthcare providers.
