Evaluating the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewing Colon Images

The trial is a prospective,multi-center, randomized and self-controlled clinical trial. The research plan will be implemented in a clinical trial center with the qualification of clinical trial agency, and 128 subjects will be planned to be included. Subjects signing the Informed Consent Form, meeting the trial conditions and all inclusion criteria and failing to meet any exclusion criteria will be included in the research. The trial device was Colon Capsule Endoscope System for colonoscopy(PC-I) manufactured by ANKON Technologies Co.,Ltd. while the comparator device was Capsule Endoscopy System(PillCam COLON2) manufactured by Given Imaging Inc. The main evaluation indicator is the excellent rate of image quality, while secondary evaluation indicators are the consistency rate of lesion detection, completion rate of colonoscopy, discharge time of capsule endoscopy, colon passing time and device performance evaluation. Safety evaluation indicators include adverse events(or Serious adverse events), device-related adverse events(or Serious adverse events) and device defects. In the end, the effectiveness and safety of Colon Capsule Endoscopy diagnostic system manufactured by ANKON Technologies Co.,Ltd. for capturing and viewing colon images clinically were verified according to the above indicator results.