Comparative Analysis of AI Software for Enhanced Polyp Detection and Diagnosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorSahlgrenska University Hospital
About this trial
Purpose \& Research Questions
The purpose of this study is to evaluate whether artificial intelligence (AI) improves the detection of polyps and whether the system can classify the type and severity of detected changes. The investigators will also assess if there are any differences between the various AI systems and whether the polyps that may be missed are benign or malignant.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 50 years
Elective colonoscopy
Disqualifiers
Patient declines to participate in the study.
Age < 50 years
Unprepared bowel
Trial design
Design model
Parallel
Treatments tested in this trial
AI
DeviceAI system
Treatment groups
915 Participants
are divided into 4 treatment groupsGroup A: CAD-EYEActive comparator 1 intervention
Group B: GI-GENIUSActive comparator 1 intervention
Group C: Endo-AIDActive comparator 1 intervention
Group D: No AINo intervention 0 interventions
Trial outcomes
Primary outcomes
1
To compare the effectiveness of AI systems in characterizing polyps with conventional histology
The endoscopist's ability to characterize lesions with and without AI will be assessed, and this assessment will be compared to histology
Time frame
During procedure (5minutes)2
Comparison of Adenoma Detection Rates (ADR) between colonoscopies assisted by Artificial Intelligence (AI) and conventional colonoscopies without AI
The ADR is typically expressed as a percentage and is calculated using the following formula:Number of colonoscopies with adenoma detection/ Total number of colonoscopies ×100.
Time frame
During procedure (up to 40 minutes)3
To assess and compare the costs associated with AI-assisted colonoscopy versus conventional colonoscopy.
Each cost associated with each examination, whether using AI-assisted or conventional colonoscopy, will be recorded prospectively.
Time frame
During procedure (5minutes)Sponsors and contacts
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Source ClinicalTrials.gov