Check-Cap announced positive final results from its completed post-CE approval study evaluating the efficacy and safety of the C-Scan system.
“The final results from the post-CE approval study confirm the potential clinical value of the C-Scan system. The results also demonstrate an advancement in the detection of larger polyps, generally considered to have higher potential for malignant transformation,” Nadir Arber, MD, MSc, MHA, director of the Integrated Cancer Prevention Center at the Tel-Aviv Sourasky Medical Center, said in a press release.
Arber and colleagues conducted a multi-center, open-label, home monitoring, prospective study to determine the performance characteristics of the C-Scan system for detecting pre-cancerous polyps compared with the fecal immunochemical test.
The study comprised 90 patients with either confirmed polyps or who were considered as average risk for polyps.
Each patient ingested a C-Span capsule and took part in a FIT as well as a comparative colonoscopy performed by independent gastroenterologists who were blinded to the test results.
Sensitivity and specificity of the C-Scan system compared with FIT in identifying patients with polyps 10 mm or larger served as the primary endpoint.
Study results demonstrated that the capsule conferred a sensitivity of 76% in patients with polyps 10 mm or larger, while FIT conferred a sensitivity of 29% in those patients.
The C-Scan system achieved a specificity of 82% in all patients, while FIT achieved a specificity of 96% in all patients.
Arber noted that there is an unmet need for patient-friendly and preparation-free screening options that can detect polyps in the colon, and how this device can help improve screening adherence.
“Although colorectal cancer can be prevented through the detection of precancerous polyps, screening adherence remains low due to the bowel preparation, sedation and invasiveness associated with current screening methods,” Arber said in the release. “I am encouraged by C-Scan’s potential to reduce global incidence of colorectal cancer and I look forward to seeing this ‘swallow and forget’ product available in clinics worldwide.”