Actively Recruiting
Comparative Analysis of AI Software and Conventional Colonoscopy for Enhanced Polyp Detection and Diagnosis: A Randomized Controlled Trial
Led by Sahlgrenska University Hospital · Updated on 2025-11-24
915
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate whether artificial intelligence (AI) can improve the detection and classification of polyps during colonoscopy. The study compares different AI systems to see if they differ in their ability to find polyps and whether missed polyps are benign or malignant. This randomized controlled clinical trial is conducted at several hospital sites with patients undergoing elective colonoscopy. Participants are randomly assigned to receive either a colonoscopy using one of three AI systems—EndoAid, CADEYE, or GI-Genius—or a conventional colonoscopy without AI assistance. During AI-assisted colonoscopy, the AI system is activated during instrument withdrawal to identify and alert the endoscopist about polyps. Two AI systems also provide interpretations regarding the benign or malignant nature of the polyps. After the procedure, questionnaires are completed documenting the findings. During the study, data collected includes patient demographics, medical history, examination details such as polyp number and classification, bowel preparation quality, procedure times, and any complications. Researchers will compare adenoma detection rates and the accuracy of AI polyp characterization against conventional histology. Costs associated with AI-assisted versus conventional colonoscopy will also be assessed. Participation involves one colonoscopy procedure with data recorded during and after the examination.
CONDITIONS
Brief Title
Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age greater than 50 years
- Scheduled for elective colonoscopy
You will not qualify if you...
- Patient declines to participate in the study
- Age less than 50 years
- Unprepared bowel
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 - Up to 40 minutes
Participants undergo either AI-assisted or conventional colonoscopy to detect and characterize polyps. The AI system, if assigned, is activated during instrument withdrawal to identify and classify polyps. Data on polyp detection, characterization, procedure duration, and costs are collected during the examination.
1 procedure visit (in-person)
Trial Site Locations
Total: 1 location
1
Sahlgrenska University Hospital
Gothenburg, Gothenbburg, Sweden, 41345
Actively Recruiting
Research Team
J
Jonas Varkey, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here