Effectiveness of Artificial Intelligence-Assisted Colonoscopy for Adenoma Detection in Routine Clinical Practice : a Prospective Multicenter Randomized Trial
Colorectal NeoplasmsColonic PolypAdenomaColorectal Cancer
Investigational drug(s) / intervention(s)
AI-Assisted Colonoscopy
AI-Assisted Colonoscopy: High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system.
Study summary
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.
Eligibility
Sex
ALL
Min age
40 Years
Max age
74 Years
Healthy volunteers
Accepted
Inclusion Criteria:
1. Age 40 to 74 years, inclusive; men and women.
2. Scheduled for elective screening, diagnostic, or surveillance colonoscopy.
3. In generally good condition, mentally competent, and willing to provide written informed consent.
Exclusion Criteria:
1. Known contraindication to colonoscopy or to biopsy.
2. History of colon cancer or previous colonic surgery.
3. Bowel obstruction; confirmed or highly suspected colorectal cancer; inflammatory bowel disease; or active colorectal bleeding.
4. Colorectal polyposis, including a history of familial adenomatous polyposis.
5. Pregnancy or breastfeeding.
6. Participation in another drug or medical device clinical trial within 1 month before enrollment.
7. Any other condition that, in the investigator's judgment, makes the participant unsuitable for this trial.
Withdrawal Criteria:
1. Withdrawal of consent by the participant.
2. Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) total score below 6 or any segment score below 2.
3. Failure to reach the cecum.
4. Newly diagnosed active colitis during the procedure.
Primary outcome measure(s)
Adenoma Detection Rate (ADR) — From the day of the procedure up to 14 days post-procedure. 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.
Trial sites (1)
Facility
City
Region
Status
The Second Affiliated Hospital, Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.