Prospective Study of EndoAim: ASUS AI Solution for Colorectal Polyp Diagnosis
Recruiting now · Not applicable
Conditions studied: Adenoma Colon Polyp
In brief
"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."
Key facts
- Study ID
- NCT06656312
- Run by
- Wen-Hsin Huang
- People needed
- 548
- Starts
- 2024-10-28
- Expected to finish
- 2025-09-14
- Last updated by the study team
- 2024-10-31
Who can join
Age: 20 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 20 or older.
- Undergoing colonoscopy using the Olympus series endoscopes.
- Following a low-residue diet and undergoing bowel preparation.
You may not qualify if…
- Poor bowel cleansing. Note: 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.
Where it is running
- China Medical University Hospital — Taichung, North Dist., Taiwan (enrolling)
Full record on ClinicalTrials.gov
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