Researchers evaluated the C-Scan System on a pilot basis. Forty patients ingested a C-Scan capsule, and then underwent a fecal immunochemical test and a comparative colonoscopy. Twenty-eight of the patients were evaluable.
All 40 patients completed the procedure and a questionnaire afterward. All 40 patients said their satisfaction levels were higher after the C-Scan than the colonoscopy.
Researchers found the 28 evaluable patients had similar CRC polyp detection profiles to the company’s previous post-CE approval study.
Check-Cap will now begin the investigational device exemption process. The company expects to launch a U.S. pivotal study in late 2020. The C-Scan already received regulatory approvals in the European Union and Israel.
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