Evaluation of safety usability and subject compliance while using Check- Cap s C-Scan System for providing structural information on colonic polypoid lesions and masses

Brief description of study

Colorectal cancer (CRC) is the 2nd leading cause of cancer death in most countries of the world. In the US, the adherence to CRC screening guidelines is much higher : ~50% of the target population are screened by Colonoscopy and about additional 10% are tested by FIT (blood in stool). It is the only cancer which is almost entirely preventable by early detection and removal of polyps that may turn into colon cancer over a 5-10 year period. However, the screening rates for CRC worldwide are expected to be much higher in order to reduce the number of new cases. The purpose of this study is to evaluate the safety and effectiveness of the Check-Cap C-Scan capsule system. It is a single-use, investigational medical device that may enable a painless procedure for CRC cancer screening. Investigational means it hasn't been approved, for commercial use, by the US Food and Drug Administration (FDA). The information gained via the C-SCAN capsule system will be compared with the information obtained during a follow-up optical colonoscopy or polypectomy (a test to look for growths in the lining of the colon) procedure.

Clinical Study Identifier: s18-01054
ClinicalTrials.gov Identifier: NCTs18-01054