RecruitingNot ApplicableNCT06656312

Prospective Study of EndoAim: ASUS AI Solution for Colorectal Polyp Diagnosis

Prospective Study of ASUS Endoscopy AI Solution- EndoAim Assisting Diagnosis of Colorectal Polyps


Sponsor

Wen-Hsin Huang

Enrollment

548 participants

Start Date

Oct 28, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

"The colorectal cancer mortality rate in Taiwan ranks third among all cancers, so it is crucial to prevent colorectal cancer through regular colonoscopy screenings and remove polyps with higher cancer risk. However, during colonoscopy, doctors tend to miss about 22% to 28% of polyps, and 20% to 24% of these missed polyps may turn into cancerous adenomas. Introducing an Artificial Intelligence (AI) assisted system can improve the overall quality of colonoscopy. This study aims to evaluate the effectiveness of the ASUS AI-assisted system (EndoAim) in diagnosing polyps during colonoscopy. It includes comparing the outcomes of colonoscopy with and without the use of EndoAim and assessing the impact of EndoAim on diagnostic effectiveness across different subgroups. Each participant will be randomly assigned to undergo a colonoscopy with or without the assistance of EndoAim. The performance of the AI-assisted system in colonoscopy will be comprehensively evaluated using indicators such as APC(Adenoma Per Colonoscopy), ADR(Adenoma Detection Rate), PDR(Polyp Detection Rate), and Positive Predictive Value (PPV).. A subgroup analysis will also be conducted based on several important factors. Polyps will be biopsied and sent for pathological examination, with the pathology report serving as the final diagnosis for subsequent analysis."


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether an AI-assisted colonoscopy system called EndoAim (developed by ASUS) can detect more colorectal polyps than standard colonoscopy alone. Colonoscopy can miss up to 28% of polyps, and AI tools that analyze images in real time may help doctors catch more of these potentially pre-cancerous growths. Eligible participants are adults aged 20 or older who are scheduled for a colonoscopy using Olympus endoscopes, have completed bowel preparation, and have not taken anticoagulants recently. Participants are randomly assigned to have their colonoscopy performed with or without AI assistance, and any polyps found are biopsied and sent for pathology. This summary was prepared using AI to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEUse ASUS EndoAim as an assistant software to perform colonoscopy

Use ASUS EndoAim as an assistant software to perform colonoscopy


Locations(1)

China Medical University Hospital

Taichung, North Dist., Taiwan

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NCT06656312


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