C-Scan, a novel X-ray imaging capsule that does not require bowel cleansing, accurately detected colon polyps in a multicenter trial published in Gut.
Nadir Arber, MD, head of the Health Promotion Center and Integrated Cancer Prevention Center at the Tel-Aviv Sourasky Medical Center, and colleagues wrote that the capsule — developed by Check-Cap — can overcome the requirement for bowel preparation, a major deterrent to colorectal cancer screening.
“I believe that results from the multicenter clinical study have demonstrated that the C-Scan imaging capsule is safe, well tolerated, and can correctly identify polyps with the majority of the colon imaged,” Arber said in a press release. “The risk of false polyp identification has been shown to be consistently low. Overall, we see the potential for C-Scan to overcome barriers to colorectal cancer screening, given its lack of requirement for bowel and other cathartic preparations.”
In a prospective, multicenter study, Arber and colleagues analyzed data from 45 patients who underwent the capsule screening, as well as a fecal immunochemical test to compare the sensitivity and specificity for polyp detection with both procedures. Investigators then conducted colonoscopies on the patients to confirm polyp detection.
The C-Scan capsule had a 45% sensitivity in detecting polyps compared with 37% for FIT. The capsule’s sensitivity increased to 78% when more than half of the colon surface was imaged (P = .0006), and 100% in a subgroup with more than 70% imaging (P = .001). Specificity was 90% in the group with 50% of the colon surface imaged and 86% in the group with 70% of the colon surface imaged, according to the study.
C-Scan received a CE mark from the European Commission in January. The company said it would commence U.S. pilot trials in addition to post-approval European trials in the first half of 2018.
“The data demonstrated the system's safe passage, ultra-low radiation exposure and ability to identify polyps without the need for bowel preparation, a major deterrent to CRC screening,” Alex Ovadia, CEO of Check-Cap said in a press release. “We will continue to evaluate our C-Scan Version 3 system in the ongoing EU post approval study, with interim results expected in [the third quarter] of 2018.” – by Alex Young
Disclosures: Arber reports that he has received consulting fees from Check-Cap. Ovadia is employed by Check-Cap. Please see the full study for the other authors’ relevant financial disclosures.