Mo1657 EVALUATION OF SAFETY, USABILITY, AND PATIENT COMPLIANCE USING C-SCAN SYSTEM FOR COLORECTAL CANCER SCREENING: US PILOT STUDY

Abstract

Current strategies to prevent colorectal cancer (CRC) vary considerably with regard to effectiveness, up-front costs, risks, invasiveness and patient compliance. A known barrier for patients is the cleanse needed for colonoscopy. A non-invassive screening test where structural information could be provided, but not require cleansing of the colon. The C-Scan® capsule-based system is a preparation-free test for CRC screening. The system is based on a low dose radioactive (RA) sealed source embedded in the C-Scan capsule, which radiates X-Rays through a collimator to all directions. The capsule starts scanning in the cecum and the X-ray is emitted when the capsule is passing through. When not moving the capsule is set at an idle mode and the radiation X-ray source is blocked. During the passage of the capsule in the colon, it transmits information to a recorder. The data from the C-Scan Track is then analyzed. The aim of this study was to demonstrate the safety, usability and patient compliance of the C-Scan System (image 1). A multicenter prospective open label single arm study enrolled patients who were eligible for CRC screening. 40 out of 45 patients were included in the study. The five patients not included were unable to swallow the capsule (n=2) or had renal impairment. Mean age was 52.9 ± 5.7 years and 35.8% were male with 85% being Caucasian. No serious adverse events occurred. The most common complaint was self-limiting abdominal cramping from fiber to aid capsule transit. All patients passed the capsule. The mean radiation exposure was 8.4±7.6 (μSv) ,less than a CXR. The mean capsule transit time from ingestion to expulsion was 65.2Hr ± 51.9 Hr. Patient compliance was 100% with all 40 patients that swallowed the capsule. Satisfaction was based on a survey questionnaire using a scoring system 1(strongly disagree) to 5(strongly agree). C-scan was deemed easier than colonoscopy with a score of 4.05 compared to 2.91. C-scan was also more likely be recommended with a score of 4.18 compared 2.86 for colonoscopy. The C-Scan view output data included YES / NO for identification of patients with colon polyps. In 3 patients (10.7% of the analyzed patients), polyps at a size range of 6-9mm were found at colonoscopy. C-Scan identified polyps in 2/3 polyps. Of the 9 patients excluded (data capture failure) from C-scan analysis, 2 had a positive FIT test and polyps >10 mm detected at colonoscopy. To continue to reduce new cases of colon cancer each year, CRC screening compliance is key. Colonoscopy is the gold standard, but patient adherence remains a challenge. In this study, C-Scan demonstrated safety with high patient satisfaction and compliance. Future are planned to improve data capture allowing for increased C-scan analysis and to assess polyp detection in comparison to colonoscopy.