Given Imaging Ltd. (Given Imaging), is planning to complete clinical trial entitled “Evaluation of the PillCam Colon Capsule -2 System” for PillCam COLON by December 2009. The objective of the study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon. The trial is being conducted across Israel.
This study is designed to evaluate the performance of the new version of colon capsule and its performance in detecting lesions in the colon as compared to conventional colonoscopy. The cohort, prospective study is currently recruiting approximately 200 participants. The principal investigator is Rami Eliakim, Prof. Rambam Health Care Campus.
The PillCam COLON video capsule measures 11 mm X 31 mm and contains an imaging device at each end. It captures 4 images per second during the 10-hour procedure. The video capsule was initially developed to help physicians to visualize the colon. It is currently being used for patients who have had an incomplete colonoscopy, who are contraindicated for a colonoscopy or prefer not to have a colonoscopy. Images are downloaded by the physician to the given workstation for review and diagnosis. The proprietary RAPID software installed on the workstation contains an image atlas to help facilitate the analysis.