Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN)
NCT07307547 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3342
Last updated 2026-02-10
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.
Conditions
- Colorectal Neoplasms
- Colonic Polyp
- Adenoma
- Colorectal Cancer
Interventions
- DEVICE
-
AI-Assisted Colonoscopy
High-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system.
Sponsors & Collaborators
-
Zhejiang University
lead OTHER
Principal Investigators
-
Kefeng Ding, M.D., Ph.D. · Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SCREENING
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2028-12-31
- Completion
- 2028-12-31
Countries
- China
Study Locations
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