Efficacy of AI-Assisted Colonoscopy for Screening Colorectal Neoplasia (AI-COLOSCREEN)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang University
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
AI-Assisted Colonoscopy
DeviceHigh-definition colonoscopy procedure with a real-time video analyzed artificial intelligence system.
Treatment groups
3,342 Participants
are divided into 2 treatment groupsGroup A: Experimental: AI-Assisted ColonoscopyExperimental treatment 1 intervention
Group B: Control: Conventional ColonoscopyNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From the day of the procedure up to 14 days post-procedure.Secondary outcomes
1
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.
Time frame
From the day of the procedure up to 14 days post-procedure.2
Advanced Adenoma and Sessile Serrated Adenoma/Polyp (SSA/P) Detection Rate
The proportion of participants with at least one histologically confirmed advanced adenoma (defined as ≥10mm, or with high-grade dysplasia or villous components) or SSA/P.
Time frame
From the day of the procedure up to 14 days post-procedure.3
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).
Time frame
Assessed within 1 hour after completion of the colonoscopy procedure.4
Physician Satisfaction Score
Assessed using a 5-point Likert scale questionnaire evaluating the AI system's usability and reliability (1=very unsatisfied, 5=very satisfied).
Time frame
Assessed within 1 hour after completion of the colonoscopy procedure.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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