Evaluating the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewi… (NCT05308511) | Clinical Trial Compass
CompletedNot Applicable
Evaluating the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewing Colon Images
China128 participantsStarted 2022-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years old (including 18 years old), male or female;
* Subjects intending to take capsule endoscopy and/or the electronic endoscopy of the lower digestive tract;
* The subject signed the ICF voluntarily.
Exclusion Criteria:
* Subjects suffering from swallowing obstruction or deglutition disorders;
* Subjects who underwent gastrointestinal abdominal surgery in the past 6 month (except for simple surgery unlikely to cause intestinal obstruction according to the clinical judgment of researchers).
* Subjects of CRC (advanced adenomatous polyp and CRC) failing to undergo the surgery;
* Subjects suffering from gastrointestinal obstruction, stenosis or fistula;
* Subjects being unable to take capsule endoscopy due to intestinal preparation failure;
* Subjects with cardiac pacemakers or other implantable electronic medical devices;
* Subjects failing to meet requirements for the abdominal surgery or refusing to take any abdominal surgery;
* Female subjects during pregnancy, lactation or having a pregnancy plan recent 3 months;
* Subjects who underwent colonoscopy within 2 years, with the negative result;
* Subjects suffering from type 1 or type 2 diabetes;
* Subject taking incomplete colonoscopy due to enteropathy of severe ulcerative colitis, radiation enteritis or non-steroidal anti-inflammatory drugs\[4\];
* Subjects suffering from any disease considered to increase the retention risk of the capsule endoscopy;
* Subjects currently participating in …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The excellent rate of image quality.
Timeframe: 1 day
Trial details
NCT IDNCT05308511
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology