809 In Vivo Colonic Insufflation via a Disposable CO2 Insufflation System

Abstract

Background: One of the major obstacles (~30%) of screening colonoscopy is the hurdle of preparation. The standard technologies demands aggressive bowel cleansing that hamper patient's compliance. Aim: To test the safety and proof of concept of a novel prep-less XRay imaging capsule (Check Cap Ltd, Israel) for colon cancer screening. Material and Methods: The capsule (approximately 34 mm in length and 11.5 mm in diameter, similar in size to optical imaging capsules) utilizes a novel ultra-low dose (0.03 mSv) low energy (56 70 Kev) X-ray-based imaging technology to safely generate high resolution 3-D imagery of the colon without bowel cleansing or other aggressive preparation. 10 capsules were swallowed by volunteers (M=7, F=3) (ages 37 66) and were tracked during the whole passage of the capsule in the body using radio frequency telemetry and an Electromagnetic Localization System (ELS). The capsules were programed to perform scans when movement in the colon is detected and transmit the imaging data to an external recorder unit worn by the patients. The study was approved by the IRB of the Tel Aviv Medical Center. Total transit time and total X-ray exposure to the patients were calculated to assess the safety profile of the x-ray capsule imaging technology in human subjects. Results: All capsules were swallowed and naturally exerted by the volunteers without any minor or major side effect. The average transit time of 68 ±31 hours. The volunteers were exposed to an ultralow total radiation dose (Average total exposure (0.03 ± 0.007 mSv), two orders of magnitude less than CTC (with 1 outlier due to manufacturing fault). Data from scans in the colon combined with ELS positioning information was used to reconstruct 3D colon segments in un-prepped colon. Fig1 and Fig.2 are examples of such 3D scans. Laboratory data form synthetic colon phantoms with and without polyps as well as data from cow colon phantom with induced tissue made polyp Fig.3 and Fig.4 have shown reconstruction accuracy of 2 3 mm in colon diameter measurements. (All figure dimensions in mm) Conclusions: A safety and proof of concept study has been performed using a novel prep-less x-ray imaging capsule for colon cancer screening. Quantitative ultra-low dose x-ray 3D imaging was achieved in the colon of human subjects. The efficacy will be confirmed in a multi-center study.