This study is a multi-center, randomized controlled trial designed to evaluate whether an artificial intelligence (AI) system can assist endoscopists to improve the detection rate of colorectal adenomas and cancers during colonoscopy compared to standard colonoscopy. Early screening and diagnosis are key to reducing the burden of colorectal cancer, but current colonoscopy has limitations, including the risk of missed lesions. This trial aims to determine if AI can enhance screening quality and diagnostic accuracy.
Age 40 to 74 years, inclusive; men and women.
Scheduled for elective screening, diagnostic, or surveillance colonoscopy.
In generally good condition, mentally competent, and willing to provide written informed consent.
Known contraindication to colonoscopy or to biopsy.
History of colon cancer or previous colonic surgery.
Bowel obstruction; confirmed or highly suspected colorectal cancer; inflammatory bowel disease; or active colorectal bleeding.
Colorectal polyposis, including a history of familial adenomatous polyposis.
Parallel
AI-Assisted Colonoscopy
DeviceHigh-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system.
Adenoma Detection Rate (ADR)
The proportion of participants with at least one histologically confirmed colorectal adenoma or adenocarcinoma. Detection and specimen collection occur during the colonoscopy, with final confirmation based on pathology reports.
Mean Adenomas Per Colonoscopy (APC)
The mean number of histologically confirmed adenomas detected per participant. The number of polyps is counted during the procedure, but confirmation of adenoma status depends on pathology.
Advanced adenoma detection rate
The proportion of participants with at least one histologically confirmed advanced adenoma, defined as an adenoma at least 10 mm in diameter, or with high-grade dysplasia, or with a villous component.
Serrated lesion detection rate
The proportion of participants with at least one histologically confirmed flat serrated lesion, including sessile serrated lesions with or without dysplasia and traditional serrated adenomas. Hyperplastic polyps are reported separately.
Patient Satisfaction Score
Assessed using a 5-point Likert scale questionnaire evaluating examination comfort and acceptance of the AI system (1=very unsatisfied, 5=very satisfied).
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This trial is not recruiting at the moment. You can still explore other options:
