Actively Recruiting
Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions
Led by Evergreen General Hospital, Taiwan · Updated on 2025-11-20
1090
Participants Needed
4
Research Sites
88 weeks
Total Duration
On this page
Sponsors
E
Evergreen General Hospital, Taiwan
Lead Sponsor
C
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to compare the detection rate of clinically significant serrated lesions (CSSL) in participants undergoing water exchange (WE) colonoscopy with artificial intelligence (AI)-based computer-aided detection (CADe) for screening, surveillance, diagnosis for symptoms, or referred owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result. There will be two arms in this study: WE with AI-assisted CADe (WEAID) control and WEAID plus linked-color imaging (LCI). The main question it aims to answer is whether the addition of LCI into WEAID colonoscopy increases CSSL detection rate. Both groups use water instead of air to insert the colonoscope into the cecum. The control method uses CADe to help detect colonic lesions. The study method uses a combination of CADe and LCI to detect lesions. Researchers will compare CSSL detection rate to see if the addition of LCI increases the detection of CSSL during CADe-assisted WE colonoscopy.
CONDITIONS
Official Title
Computer-Aided Water Exchange Colonoscopy With and Without Linked-Color Imaging for Detection of Clinically Significant Serrated Lesions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female patients aged 40-80 years scheduled for average-risk screening colonoscopy, post-polypectomy surveillance, diagnosis for gastrointestinal symptoms (including unexplained iron deficiency anemia and clinically significant diarrhea of unexplained origin), or referred for colonoscopy owing to a positive fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT) result.
You will not qualify if you...
- Familial adenomatous polyposis and hereditary non-polyposis colorectal cancer syndrome
- Personal history of serrated polyposis syndrome
- Personal history of colorectal cancer
- History of inflammatory bowel disease
- Previous colonic resection
- Overt gastrointestinal bleeding
- Emergency colonoscopy or inpatient status
- Planned endoscopic mucosal resection or endoscopic submucosal dissection of large polyps
- Colon stricture or obstruction
- Contraindications to colonoscopy such as acute diverticulitis or toxic megacolon
- Antithrombotic therapy that prevents complete polyp removal
- American Society of Anesthesiology physical status classification greater than 3
- Pregnant women or women planning pregnancy
- Refusal to provide written informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 4 locations
1
University of Montreal Medical Center (CHUM)
Montreal, Quebec, Canada, H2X 0A9
Not Yet Recruiting
2
Ospedale Valduce
Como, Italy, 22100
Not Yet Recruiting
3
Evergreen General Hospital
Taoyuan, Taiwan, 320
Actively Recruiting
4
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330
Not Yet Recruiting
Research Team
C
Chi-Liang Cheng, MD
CONTACT
R
Rungsun Rerknimitr, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SCREENING
Number of Arms
2
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