Check-Cap Ltd. is reporting positive results from a pilot study of its C-Scan System. The Isfiya, Israel-based company’s C-Scan System is a preparation-free ingestible scanning capsule-based system for the prevention of colorectal cancer through the detection of precancerous polyps.
Results from the pilot study show that no device or procedure-related serious adverse events were reported and all device or procedure-related adverse events were mild in severity. In total, 45 patients enrolled in the study, of which 40 patients underwent the study procedure.
All 40 patients complied with the procedure and completed a questionnaire following the procedure and reported higher satisfaction with the C-Scan System procedure compared to colonoscopy.
A total of 28 patients were evaluable after factoring in technical and physiological dropouts and protocol violations. Analysis of the evaluable patient results revealed an agreement between C-Scan and colonoscopy in detection of polyps was consistent with data from the post-CE approval study.
In a release, Alex Ovadia, CEO of Check-Cap, commented, "We are pleased with the positive results from this U.S. pilot study. Completing our first study in the U.S. constitutes an important milestone for our company as we work towards the initiation of a U.S. pivotal study in late 2020. We are now focused on preparing our IDE submission to FDA and collecting additional clinical data utilizing a new version of our C-Scan System, while at the same time continuing to build out our global operational infrastructure. We believe 2020 will be a meaningful year for Check-Cap."
The company received FDA conditional approval for IDE to initiate the pilot study in December of 2018 and received a CE mark about 11 months earlier.
After being swallowed in capsule form, the C-Scan system's ultra-low-dose X-ray technology is used to produce a 3-D map of a patient's colon. The system differs from capsule technology already on the market by eliminating the need for a bowel prep prior to ingestion and examining the colon in its natural state without distention.
The system produces a 3-D contour map of the colon that can be viewed in different ways to look for polyps, including a "tube" view a flat "fillet" view, or even the outside of the surface of the colon wall.