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

ConditionAdenoma Colon Polyp

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age20+

SponsorWen-Hsin Huang

About this trial

"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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age 20 or older.

Undergoing colonoscopy using the Olympus series endoscopes.

Following a low-residue diet and undergoing bowel preparation.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Use ASUS EndoAim as an assistant software to perform colonoscopy
Device
Use ASUS EndoAim as an assistant software to perform colonoscopy

Treatment groups

548 Participants

are divided into 2 treatment groups

Group A: AI GroupExperimental treatment 1 intervention

Group B: Normal GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

APC(Adenoma per colonocopy)

Rate of Adenoma Per Colonoscopy (APC) Increase in AI(Artificial Intelligence)-Assisted Group Compared to Standard Group Total Adenoma Polyps Findings/Total Performed Colonoscopy

Time frame

30 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wen-Hsin Huang

Lead sponsor

China Medical University Hospital

Sponsor institution

Source ClinicalTrials.gov

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