Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy
This is an investigator-initiated multicentre non-randomized prospective interventional trial to validate the performance of a novel state-of-the-art computer-aided diagnostic (CAD) tool in polyp detection implemented as second observer during routine diagnostic colonoscopy and to evaluate its feasibility in daily endoscopy. Patients referred for a screening surveillance or therapeutic colonoscopy will undergo a colonoscopy performed by an endoscopist with moderate to high adenoma detection rate (ADR \> 20% and \< 50%) while a second observer will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative, (3) other positive and (4) obvious false positive. When a doubtful detection is made by the AI-system, the second observer will ask to re-evaluate the indicated region. When the detection is clear, the endoscopist and second observer do not communicate. The entire procedure is recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
357
Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium
Diagnostic accuracy of the novel AI system compared to endoscopic diagnosis as gold standard
Determination of the diagnostic accuracy of the novel AI system as second observer
Time frame: 4 months
Endoscopist's polyp miss rate as number of extra AI detections
Determination of the AI system's precision and extra value as second observer
Time frame: 4 months
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