Actively Recruiting
Prospective Study of ASUS Endoscopy AI Solution- EndoAim Assisting Diagnosis of Colorectal Polyps
Led by Wen-Hsin Huang · Updated on 2024-10-31
548
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Colorectal cancer is a leading cause of cancer-related deaths in Taiwan, ranking third in mortality. Preventing colorectal cancer relies heavily on regular colonoscopy screenings and removing high-risk polyps. However, doctors can miss about 22% to 28% of polyps during colonoscopy, and 20% to 24% of these missed polyps may develop into cancerous adenomas. Researchers are evaluating the effectiveness of the ASUS AI-assisted system called EndoAim to improve the accuracy of polyp detection and diagnosis during colonoscopy. Participants in this randomized study will be assigned to one of two groups: colonoscopy performed with the assistance of the EndoAim AI software or standard colonoscopy without AI support. The study focuses on key performance indicators such as Adenoma Per Colonoscopy (APC), Adenoma Detection Rate (ADR), Polyp Detection Rate (PDR), and Positive Predictive Value (PPV). Polyps found during the procedure will be biopsied and examined pathologically to confirm diagnosis. Subgroup analyses will explore the AI system's impact based on factors like screening type, bowel cleanliness, physician experience, and polyp location. During the study, participants will undergo colonoscopy using Olympus series endoscopes after following a low-residue diet and bowel preparation. Researchers will collect data on adenoma detection and polyp diagnosis effectiveness. The primary measurement is APC evaluated within 30 days. Safety monitoring includes ensuring adequate bowel cleansing and complete colonoscopy reaching the cecum. Study participation timeline and follow-up are aligned with the colonoscopy procedures and pathology results.
CONDITIONS
Brief Title
Prospective Study of EndoAim: ASUS AI Solution for Colorectal Polyp Diagnosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 or older
- Scheduled to undergo colonoscopy using Olympus series endoscopes
- Following a low-residue diet and completing bowel preparation
You will not qualify if you...
- Poor or inadequate bowel cleansing based on Aronchick scale
- Incomplete colonoscopy not reaching the cecum
- Use of anticoagulant medications or abnormal coagulation within the last 5 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 day
Participants undergo colonoscopy procedures with or without AI assistance to diagnose colorectal polyps.
1 visit (in-person)
Duration - 30 days
Participants are observed following colonoscopy to monitor outcomes related to polyp detection and diagnosis.
Trial Site Locations
Total: 1 location
1
China Medical University Hospital
Taichung, North Dist., Taiwan, 404332
Actively Recruiting
Research Team
H
Hsing-Hung Cheng, MD
W
Wen-Hsin Huang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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