Check-Cap announces final results from post-CE approval study of C-Scan system
Check-Cap announced final results from its recently completed post-CE approval study evaluating the clinical performance and safety of the C-Scan system. The multi-center, open label, home monitoring, prospective study was designed to determine the performance characteristics of Check-Cap's capsule-based screening test, the C-Scan system, for detecting pre-cancerous polyps compared with the fecal immunochemical test, or FIT, a commonly used non-invasive colorectal cancer screening test; in each case using colonoscopy as the reference method. The study included 90 evaluable patients who either had known polyps or were considered to be of average risk. Each patient ingested a C-Scan capsule and also underwent a FIT and a comparative colonoscopy performed by independent gastroenterologists, who were blinded to the corresponding test's results. The C-Scan clinical evaluation was obtained using the evaluable patient population implementing a gender-based motility analysis and the results of both C-Scan and FIT were compared to colonoscopy. The primary efficacy endpoint of the study was sensitivity and specificity of the C-Scan system compared to FIT in detecting subjects with polyps greater than or equal to 10 mm. The results demonstrate that C-Scan achieved a sensitivity of 76% in patients with polyps greater than or equal to 10 mm, while FIT achieved a sensitivity of 29% in patients with polyps greater than or equal to 10 mm. C-Scan achieved a specificity of 82% in all patients, while FIT achieved a specificity of 96% in all patients. In addition, C-Scan detected all 4 patients with polyps greater than or equal to 40 mm, while the FIT detected only one of the four patients with polyps greater than or equal to 40mm. Overall, C-Scan achieved a sensitivity of 66% in all patients, including patients with polyps less than 10mm, while FIT achieved a sensitivity of 23% in all patients, including patients with polyps less than 10mm. In total, 142 patients enrolled in the study and after factoring in technical and physiological dropouts and protocol violations, the number of evaluable patients was 90. No serious adverse events were reported, and the adverse events were mild in severity. Check-Cap is currently conducting a pilot study in the U.S. to evaluate the safety, usability and subject compliance of the C-Scan system at the New York University School of Medicine and Mayo Clinic. In addition, Check-Cap intends to continue collecting clinical data in additional studies in preparation for its planned pivotal study. Assuming positive pilot study results, the company plans to initiate a pivotal study in people of average risk for polyps and colorectal cancer in mid-2020. The C-Scan system has received CE marking and approval from the Israeli Ministry of Health, the Medical Device Division for marketing in Israel.