Status:
COMPLETED
Evaluating the Effectiveness and Safety of Colon Capsule Endoscope System for Capturing and Viewing Colon Images
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborating Sponsors:
Renmin Hospital of Wuhan University
Beijing Tsinghua Changgeng Hospital
Conditions:
Prospective Study
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Detailed Description
According to the relevant requirements of Standard for Quality Management of Medical Device Clinical Trials (Order No. 25 of the National Health and Family Planning Commission of the People's Republic...
Eligibility Criteria
Inclusion
- 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
- 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 another clinical trial of drugs or devices;
- Other circumstances unsuitable for inclusion upon judgment by the researcher.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 4 2023
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT05308511
Start Date
April 1 2022
End Date
August 4 2023
Last Update
September 18 2023
Active Locations (1)
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1
Union Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000