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Regulatory approval for marketing in the EU and Israel

The C-Scan system has received CE mark and approval from the Israeli Ministry of Health, the Medical Device Division (AMAR) for marketing in Israel.

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Clinical Path in the U.S.

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about the study

U.S. Pilot Study

Check-Cap has completed a pilot study in the U.S. to evaluate the safety, usability and subject compliance of the C-Scan system. The study was conducted at two sites, the New York University Grossman School of Medicine and Mayo Clinic.

  • Positive results were reported from 28 evaluable study subjects (out of 40 who completed the study).
  • The primary endpoint was achieved, and no device or procedure related serious adverse events were reported.
  • All patients who underwent the study complied with the procedure and completed a questionnaire after the test, reporting higher satisfaction with the C-Scan System compared to colonoscopy.
  • The study also showed an agreement between C-Scan and colonoscopy in detection of polyps for evaluable patients, consistent with data from the post-CE approval study *.

*Due to sample size, the study was not designed to be powered for statistical significance 

U.S. Pivotal Study

  • A U.S. pivotal study is planned for 2021.

1.Prepless Colon Capsule Technology: New Research Examines This Less Invasive Approach to Colorectal Cancer Screening. Mayo Clinic Digestive Diseases Update. Gastroenterology and Hepatology. Vol 8, No.1, 2020.

The C-Scan System is not approved in the United States and is currently an investigational device there.
The system is approved in the E.U. and Israel but it is not available for sale in any jurisdiction.
This website is not intended to provide medical advice for patients or healthcare providers.

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