Artificial Intelligence (AI) Validation Study for Polyp Detection

Status Completed

Clinical Trial Summary

Interventional prospective multicenter study: Polyp detection by an automated endoscopic tool as second observer during routine diagnostic colonoscopy

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04378660
Study type	Interventional
Source	Universitaire Ziekenhuizen Leuven
Contact
Status	Completed
Phase	N/A
Start date	October 30, 2019
Completion date	April 18, 2020

View Details

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