Artificial Intelligence-assisted Colonoscopy, Tandem Study

Summary

The goal of this clinical trial is to evaluate effect of artifial intelligent (AI) system, Endoscopy as AI-powered Device (ENAD) on adenoma miss rate from colonoscopy underwent by trainee endoscopist. It will also evaluate effect of AI on adenoma and polyp detection rate from colonoscopy underwent by trainee endoscopist. The main questions it aims to answer are:

• Does AI-system lower adenoma miss rate in colonoscopy underwent by trainee endoscopist?

Researchers will do the tandem colonoscopy and devided the participant in 4 groups as follows:

A. First pass: trainee; Second pass: expert B. First pass: trainee + AI; Second pass: expert C. First pass: trainee; Second pass: expert + AI D. First pass: trainee+AI; Second pass: expert+AI Participants will take bowel preparation in split dose regimen and nothing per oral for 4 hours. They will underwent colonoscopy as above, with sedation by anesthesiologist. Details on qualities of colonoscopy, polyps detection and pathology results will be recorded.

Conditions

• Artificial Intelligence (AI)
• Colonoscopy Education
• Adenoma Colon Polyp

Interventions

DEVICE

Group A (Trainee --> expert)

The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy (white-light mode) without AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy (white-light mode) without AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent.

DEVICE

Group B (Trainee +AI --> expert)

The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy with AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy (white-light mode) without AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent. Artificial intelligent (AI) assisted colonoscopy; ENdoscopy as AI-powered Device (ENAD) ENAD system (ENdoscopy as AI-powered Device, AINEX Corporation, Seoul, South Korea) is the system using CADe system (Computer-aided detection) which developed from 66,397 images and 8,756 polyps via deep learning-based object detection algorithm (YOLOv4) . It was validated by 15,753 images of polyp from 80 colonoscopy videos and 90,144 images of non-polyps from 50 colonoscopy videos. This system decreases false positive rate from 3.2% to 0.6% and increases sensitivity from 86.4% to 87.1%.

DEVICE

Group C (Trainee --> expert + AI)

The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy (white-light mode) without AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy with AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent. Artificial intelligent (AI) assisted colonoscopy; ENdoscopy as AI-powered Device (ENAD) ENAD system (ENdoscopy as AI-powered Device, AINEX Corporation, Seoul, South Korea) is the system using CADe system (Computer-aided detection) which developed from 66,397 images and 8,756 polyps via deep learning-based object detection algorithm (YOLOv4) . It was validated by 15,753 images of polyp from 80 colonoscopy videos and 90,144 images of non-polyps from 50 colonoscopy videos. This system decreases false positive rate from 3.2% to 0.6% and increases sensitivity from 86.4% to 87.1%.

DEVICE

Group D (Trainee + AI --> expert + AI)

The expert endoscopist insert to cecum in both passes. First pass: Trainee withdraw colonoscopy with AI. The polyps detected can be removed as suitable. The pathology for polyp will be sent. Second pass: Expert withdraw colonoscopy with AI. The polyps detected (which is missed from the first pass) can be removed as suitable. The pathology for polyp will be sent. Artificial intelligent (AI) assisted colonoscopy; ENdoscopy as AI-powered Device (ENAD) ENAD system (ENdoscopy as AI-powered Device, AINEX Corporation, Seoul, South Korea) is the system using CADe system (Computer-aided detection) which developed from 66,397 images and 8,756 polyps via deep learning-based object detection algorithm (YOLOv4) . It was validated by 15,753 images of polyp from 80 colonoscopy videos and 90,144 images of non-polyps from 50 colonoscopy videos. This system decreases false positive rate from 3.2% to 0.6% and increases sensitivity from 86.4% to 87.1%.

Sponsors & Collaborators

• Mahidol University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-13

Primary Completion

2025-05-13

Completion

2026-12-31

Countries

• Thailand

Study Locations