Check-Cap touts interim post-CE Mark C-Scan study results

Check-Cap (NSDQ:CHEK) today released interim results from the post-CE Mark approval study of its C-Scan system version 3, touting the device’s ability to detect polyps in un-prepped colons. The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless tracking system to return structural information on the lumen of the colon to create 2D and 3D maps. The study aimed to assess the safety and clinical performance of the C-Scan system version 3 in detecting polyps, Check-cap said. Data came from 31 evaluable patients, the company added. Results indicated that the C-Scan version 3 had a sensitivity of 76% and a specificty of 80% in detecting polyps, with results confirmed through colonoscopies, Check-Cap said. The company said that analysis of the results were performed by independent, blinded expert investigators. “We are excited to unveil the multidimensional screening capabilities of the C-Scan system. We believe that the encouraging interim results from our ongoing post CE approval study demonstrate a significant progress in the clinical performance of C-Scan compared with previously communicated CE study results for our patient-friendly, and preparation free colon-cancer screening device. These results were achieved through the continuous improvements in cross-system algorithms, while maintaining C-Scan’s strong safety profile. ...
Source: Mass Device - Category: Medical Devices Authors: Tags: Clinical Trials Diagnostics Oncology Check-Cap Source Type: news