Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN)

Starting soon · Not applicable

Conditions studied: Colorectal Neoplasms, Colonic Polyp, Adenoma, Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT07307547

Run by

Zhejiang University

People needed

3342

Starts

2026-04-01

Expected to finish

2028-12-01

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Age between 18 and 75 years, inclusive.
• Scheduled for a screening, diagnostic, or surveillance colonoscopy.
• Able to understand the study protocol and provide written informed consent.

You may not qualify if…

• Known contraindications to colonoscopy or biopsy.
• Personal history of colorectal cancer, inflammatory bowel disease (IBD), or previous colorectal surgery.
• Known or suspected colorectal polyposis syndrome (e.g., Familial Adenomatous Polyposis - FAP).
• Patients with active colorectal bleeding, bowel obstruction, or toxic megacolon.
• Women who are pregnant, planning to become pregnant, or are breastfeeding.
• Participation in another interventional clinical trial within the 30 days prior to enrollment.
• Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study.

Where it is running

• The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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