RecruitingNot Applicable

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

Taiwan548 participantsStarted 2024-10-28

Plain-language 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."

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age 20 or older.
. Undergoing colonoscopy using the Olympus series endoscopes.
. Following a low-residue diet and undergoing bowel preparation.

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

APC(Adenoma per colonocopy)

Timeframe: 30 days

Trial details

NCT IDNCT06656312

SponsorWen-Hsin Huang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-14

Contact for this trial

Hsing-Hung Cheng, MD

+886-975680861 017124@tool.caaumed.org.tw

View on ClinicalTrials.gov More Adenoma Colon Polyp trials