Effect of Two Colonoscopy AI Systems for Colon Polyp Detection

Seoul National University Hospital3,046 enrolled

Overview

Computer-aided detection (CADe) systems have been actively researched for polyp detection in colonoscopy. The investigators aim to identify the effect of two CADe systems according to the system performance on false positive rate

Artificial intelligence technology based on deep learning is being applied in various medical fields, and research is being actively conducted to develop computer-aided detection (CADe) systems for colonoscopies to overcome the limitation of the variance of human skills. These well-trained CADe systems demonstrated high performance for neoplastic polyp detection and reported a 44% increase in adenoma detection rate (ADR) for endoscopists. However, the level of performance in the CADe system is not clear for expert endoscopists to be useful for ADR increase. Furthermore, false positives(FPs) of the CADe system may negatively influence ADR during a screening colonoscopy. Accordingly, the investigators sought to identify the effect of the colonoscopy CADe system according to FP performance in endoscopists with various levels. The investigators hypothesized that the CADe system with low FPs would be useful to prevent the decrease in ADR in case of a high endoscopy workload according to the performance of CADe systems.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

3,046

Conditions

Adenoma Colonoscopy Sessile Serrated Adenoma

Interventions

Assist by artificial intelligence system for colon polyp detectionDEVICE

Assist by artificial intelligence system for colon polyp detection

Eligibility

Sex: ALLMin age: 45 YearsMax age: 100 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: patient for screening or surveillance colonoscopy patients agreed with participating in the study Exclusion Criteria: patients who do not agree with participating in the study patients with a history of colon resection patients with a history of inflammatory bowel resection patients with poor bowel preparation

Locations (1)

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Adenoma detection rate

proportion of colonoscopies with at least one adenoma detected overall and as detected by the physician.

Time frame: 12 months

Sessile serrated lesion detection rate

proportion of colonoscopies with at least one sessile serrated lesion detected overall and as detected by the physician.

Time frame: 12 months

Secondary Outcomes

polyp detection rate

proportion of colonoscopies with at least one polyp detected overall and as detected by the physician.

Time frame: 12 months

Data from ClinicalTrials.gov

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