- Check-Cap (NASDAQ:CHEK) announces results from a U.S.-based single-arm, open-label pilot study evaluating the safety, usability and subject compliance of its C-Scan System.
- 40 participants complied with the procedure and completed a questionnaire but only 28 were evaluable representing a 30% dropout rate due to "technical and physiological" issues and protocol violations.
- No device- or procedure-related serious adverse events were reported and all adverse events were mild.
- Analysis of the evaluable patient results showed agreement between C-Scan and colonoscopy and detection of polyps was consistent with data from the post-CE approval study.
- A pivotal study should launch in late 2020.
- The device was CE Mark'd in January 2018.