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

NCT06656312 | Recruiting

• 1 other identifier: CMUH113-REC2-146
• Study Type: interventional
• Target: 548
• Locations: 1 country
• Sites: 1

Brief 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."

Conditions

Adenoma Colon Polyp

Keywords

polyp detection; AI-assisted system; endoscopy; deep learning; colonoscopy

Outcome Measures

Primary Outcomes (1)

• 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

  30 days

Study Arms (2)

AI Group

EXPERIMENTAL

Use ASUS EndoAim as an assistant software to perform colonoscopy

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

Normal Group

NO INTERVENTION

Standard Colonoscopy

Interventions

Use ASUS EndoAim as an assistant software to perform colonoscopy DEVICE

Use ASUS EndoAim as an assistant software to perform colonoscopy

AI Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Wen-Hsin Huang: lead

Study Sites (1)

China Medical University Hospital

Taichung, North Dist., 404332, Taiwan

RECRUITING

Study Officials

• Wen-Hsin Huang, MD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hsing-Hung Cheng, MD

CONTACT

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

Wen-Hsin Huang, MD

CONTACT

+886-4-2205-2121; u97766.huang@msa.hinet.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gastroenterology and Hepatology Deputy Director

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: October 28, 2024
• Primary Completion: September 14, 2025
• Study Completion: September 14, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Locations

TW (1)