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.
More articles on surgery centers:
Montecito Medical buys MOB, ASC in Virginia: 4 details
Arkansas hospital breaks ground on ASC — 4 insights
204 new ASCs opened or announced in 2019
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.