Actively Recruiting

Phase Not Applicable
Age: 20Years +
All Genders
NCT06656312

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

Led by Wen-Hsin Huang · Updated on 2024-10-31

548

Participants Needed

1

Research Sites

45 weeks

Total Duration

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AI-Summary

What this Trial Is About

"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."

CONDITIONS

Official Title

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

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 20 or older
  • Undergoing colonoscopy using the Olympus series endoscopes
  • Following a low-residue diet and undergoing bowel preparation
Not Eligible

You will not qualify if you...

  • Poor bowel cleansing evaluated as Poor or Inadequate according to the Aronchick scale
  • Incomplete colonoscopy (not reaching the cecum)
  • Use of anticoagulant medications or abnormal coagulation function within the last 5 days

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China Medical University Hospital

Taichung, North Dist., Taiwan, 404332

Actively Recruiting

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Research Team

H

Hsing-Hung Cheng, MD

CONTACT

W

Wen-Hsin Huang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SCREENING

Number of Arms

2

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