Prospective Study of ASUS Endoscopy AI Solution- EndoAim Assisting Diagnosis of Colorectal Polyps

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• Age 20 or older.

• Undergoing colonoscopy using the Olympus series endoscopes.

• Following a low-residue diet and undergoing bowel preparation.

Locations
Other Locations
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Contact Information
Primary
Hsing-Hung Cheng, MD
017124@tool.caaumed.org.tw
+886-975680861
Backup
Wen-Hsin Huang, MD
u97766.huang@msa.hinet.net
+886-4-2205-2121
Time Frame
Start Date: 2024-10-28
Estimated Completion Date: 2025-09-14
Participants
Target number of participants: 548
Treatments
Experimental: AI Group
Use ASUS EndoAim as an assistant software to perform colonoscopy
No_intervention: Normal Group
Standard Colonoscopy
Sponsors
Leads: Wen-Hsin Huang

This content was sourced from clinicaltrials.gov