NCT04378660

Artificial Intelligence (AI) Validation Study for Polyp Detection

Artificial Intelligence Validation Trial for Polyp Detection: Pilot Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 357 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Polyp of Colon

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Artificial intelligence for polyp detection	Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer

Timeline

• Start date: 2019-10-30
• Primary completion: 2020-04-18
• Completion: 2020-04-18
• First posted: 2020-05-07
• Last updated: 2020-05-07

Locations

1 site across 1 country: Belgium