Check-Cap Reports Positive Results From CRC Screening Pilot Study
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Check-Cap announced positive results from a pilot study of its C-Scan system, an ingestible X-ray scanning capsule for no-prep colorectal cancer screening, according to a press release.
“The results of the study are promising, both in terms of safety and patient compliance of the procedure,” Seth A. Gross, MD, associate professor of medicine at NYU Langone Health and principal investigator of the study, said in the press release. "Most non-invasive colorectal cancer screening options currently available have modest efficacy detecting pre-cancerous polyps. We are excited about the potential of the C-Scan System offering a patient friendly screening option that could detect pre-cancerous polyps before they become malignant, and we look forward to seeing the C-Scan System advancing into the U.S. pivotal study in the future."
Forty patients underwent screening with the C-Scan capsule, as well as a fecal immunochemical test and comparative colonoscopy. The primary endpoint of the study was to evaluate the incidence of device or procedure-related serious adverse events, and secondary endpoints included patient compliance, satisfaction and device performance.
Results from 28 evaluable patients showed an agreement between C-Scan and colonoscopy in the detection of polyps, which was consistent with data from the company’s post-CE approval study, according to the release.
Additionally, researchers did not identify any device or procedure-related serious adverse events.
“Completing our first study in the U.S. constitutes an important milestone for our company as we work toward the initiation of a U.S. pivotal study in late 2020,” Alex Ovadia, CEO of Check-Cap, said in the release. “We are now focused on preparing our [investigational device exemption] submission to the FDA and collecting additional clinical data using a new version of our C-Scan System, while at the same time continuing to build out our global operational infrastructure.”
Disclosure: Ovadia is employed by Check-Cap. Gross reports no relevant financial disclosures.
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