Patients who underwent the C-Scan test to detect polyps before they may transform into colorectal cancer (CRC), as part of the 2019 US pilot study, were significantly more likely to recommend C-Scan test compared to colonoscopy. The findings were reported in the paper, ‘Colorectal Cancer and Polyp Detection Using a New Preparation-Free, Colon-Scan Capsule: A Pilot Study of Safety and Patient Satisfaction’, published in the journal Digestive Diseases and Sciences.
"Screening for the detection of precancerous colorectal polyps is a key approach for cancer prevention,” said Dr Seth A Gross, principal investigator of the study, gastroenterologist and associate professor of medicine at NYU Langone Health. “Yet, a known barrier for some patients is the required bowel cleansing for colonoscopy and invasiveness of the procedure. Less invasive alternatives are needed to engage a percentage of the population that avoids regular screening.”
C-Scan (Check-Cap Ltd) is an easy to swallow capsule designed to detect pre-cancerous colorectal polyps without days of uncomfortable prep. The capsule uses a series of x-rays as it moves throughout the digestive track to identify abnormalities. The goal of the prospective open label, single arm study was to determine safety and patient satisfaction with the C-Scan capsule.
The aim of this single-arm pilot study was to determine safety and patient satisfaction with the colon-scan capsule. The study was conducted at two tertiary care centres, the NYU Grossman School of Medicine and Mayo Clinic, Rochester in 2019. Eighty perccent of patients were of average risk for colorectal cancer and the mean age was 52.9. Each patient ingested a C-Scan capsule and underwent a comparative colonoscopy, which was performed by an independent gastroenterologist who was blinded to the corresponding test results.
Safety was defined by the occurrence of procedure or device-related adverse events. Satisfaction was based on survey questionnaires using a scoring system 1 (strongly disagree) to 5 (strongly agree). Patient satisfaction with the colon-scan capsule was compared to colonoscopy.
In total, 45 patients were included (52.9 [5.7] years; 64.1% females). There were no serious adverse events and no occurrences of capsule retention. The most common (12.5%) complaint was self-limiting abdominal cramping. Satisfaction questionnaires were completed by more than 87% of patients, with patients likely to recommend the capsule (score 4.1 [1.03]) compared to colonoscopy (score 2.8 [1.2]), p=0.001)).
"Our prospective single-arm pilot study demonstrated positive safety results and high patient satisfaction with a new and unique preparation-free colon capsule system intended for detection of colorectal polyps and masses,” said Dr Elizabeth Rajan, principal investigator of the study, gastroenterologist and professor of medicine, Mayo Clinic, Rochester. “This study represents a step forward to a prepless approach for CRC screening that may overcome one of the most important deterrents to screening. A multicenter pivotal study is planned in the US to further validate the performance of this technology."
"We continue to make progress in preparation for initiation of our upcoming US pivotal study, to further validate the performance, safety, and accuracy of polyp detection using C-Scan,” added Alex Ovadia, chief executive officer of Check-Cap. “We look forward to making this disruptive screening modality available to the many patients in need of patient-friendly screening tests."