Actively Recruiting
To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Observational Multicenter Study
Led by Renmin Hospital of Wuhan University · Updated on 2025-04-13
7500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a computer-aided diagnosis system based on artificial intelligence (AI) to detect colorectal polyps and improve the adenoma detection rate (ADR). This multicenter, prospective real-world study aims to compare the effectiveness of AI-assisted colonoscopy with standard colonoscopy without AI assistance. The study focuses on the clinical value of AI in polyp detection and colonoscopy quality control across multiple centers. Participants undergo colonoscopy with or without the help of the AI system called ANDOANGEL. This device assists endoscopists by marking polyps with rectangular boxes and monitoring key factors such as ileocecal position, mirror entry and exit time, and withdrawal speed during the procedure. The study compares groups receiving AI assistance and those without to evaluate differences in detection rates and procedure quality. During the study, participants will have their colonoscopy procedures monitored for adenoma detection rate, polyp detection rate, serrated adenoma detection rate, average number of polyps per procedure, colonoscopy time, and the proportion of over-speed frames. Researchers collect data in real time during the endoscopy process to assess the AI system's performance. Participants are expected to cooperate fully throughout the study and provide informed consent before enrollment.
CONDITIONS
Brief Title
Artificial Intelligence-assisted System in Colonoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 50 years old
- Require diagnostic, screening, or follow-up colonoscopy
- Voluntarily sign informed consent
- Agree to follow all study procedures and cooperate throughout the study
You will not qualify if you...
- Currently participating in other clinical trials or in follow-up from them
- Known diagnosis of polyposis syndrome
- Known diagnosis of inflammatory bowel disease (IBD)
- Considered unsuitable or unable to undergo complete digestive endoscopy by investigators
- Presence of high-risk diseases or other special conditions making participation unsuitable according to investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo colonoscopy either with or without assistance from an artificial intelligence system to identify polyps and monitor the procedure in real time.
1 visit (in-person)
Duration - Up to 1 year after colonoscopy
Participants are observed after the colonoscopy to monitor outcomes related to polyp detection and safety.
Follow-up visits as per routine care
Trial Site Locations
Total: 1 location
1
Renmin Hospital of Wuhan Univercity
Wuhan, Hubei, China, 430060
Actively Recruiting
Research Team
H
Honggang Yu, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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