Status:
RECRUITING
Clinical Efficacy Evaluation of a Computer-aided Colonoscopy as Compared With the Standard Colonoscopy.
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
Changhua Christian Hospital
Shin Kong Hospital
Conditions:
Colon Adenoma
Colorectal Cancer
Eligibility:
All Genders
40-80 years
Phase:
NA
Brief Summary
Colonoscopy is clinically used as the gold standard for detection of colorectal cancer (CRC) and removal of adenomatous polyps of the colon and rectum. Evidence has shown that CRC could be prevented b...
Detailed Description
This multiple-site study aims to evaluate whether a computer-aided detection (CADe) device can assist in adenoma detection rate (ADR) when compared with the current standard-of-care procedure. The sub...
Eligibility Criteria
Inclusion
- Subjects who have given signed informed consent form
- Informed consensus has been obtained that endoscopic resection should be performed if a lesion is found
- Subjects who are scheduled for screening or diagnostic colonoscopy for colorectal cancer (CRC) or surveillance colonoscopy for post-polypectomy follow-up
Exclusion
- Subjects with any of the following prior history or current conditions:
- Contraindications to colonoscopy
- Inflammatory bowel disease (IBD)
- Colorectal cancer (CRC)
- Familial adenomatous polyposis (FAP)
- Colonic stenosis
- Severe organ failure (cirrhosis of Child C, heart failure of ACC / AHA stage D)
- Active gastrointestinal (GI) Bleeding
- Pregnancy
- Prior colorectal surgery, including colonic or rectal resection (except for appendectomy, surgery on the anus, and polypectomy)
- Undergo colonoscopy within 3 years
- Subjects with any of the following conditions per the investigator's judgement:
- High suspicion of IBD, CRC, and FAP.
- High risk of bleeding after endoscopic treatment, and difficult management of anticoagulation or antiplatelet medication.
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT05240625
Start Date
March 1 2022
End Date
December 31 2025
Last Update
June 20 2024
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100