News | Colonoscopy Systems | January 31, 2017

Trial data will be used to support CE Mark approval of C-Scan ultra-low-dose X-ray screening device

Check-Cap, C-Scan system, colorectal cancer screening, clinical trial, CE Mark

January 31, 2017 — Check-Cap Ltd. recently announced the enrollment of the first patient in its multi-center study of the C-Scan system in support of its CE Mark submission.

C-Scan employs proprietary, ultra-low-dose X-ray technology in an ingestible capsule to create a 3-D map of the inner colon to detect polyps, which may be, or may become, cancerous. Unlike existing imaging modalities, Check-Cap's approach does not require bowel preparation, which is a significant obstacle to screening, according to the company. Designed to improve the patient experience and maximize the number of people who complete screening, C-Scan works in concert with the natural functioning of the colon, and does not require sedation or changes to diet and normal daily activities.

The current multi-center, prospective trial, designed to demonstrate the safety and clinical performance of C-Scan, will evaluate polyp detection as compared to colonoscopy. Check-Cap expects to submit for a CE Mark in the first half of 2017.

The company also plans to initiate a pilot trial in the United States in the second half of 2017, according to Check-Cap CEO Bill Densel.

Read the article "Check-Cap Initiates U.S. Pilot Study of C-Scan for Colorectal Cancer Screening"

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