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Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group: a Multi-center, Randomized Controlled Trial
Led by National Taiwan University Hospital · Updated on 2024-11-07
250
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether 3D colonoscopy improves the detection of precancerous adenomas compared to conventional 2D colonoscopy in people with positive fecal immunochemical tests (FIT), who are at higher risk for colorectal cancer. Adenoma detection rate (ADR) is a key quality measure linked to colorectal cancer risk, and this study aims to see if 3D imaging can better detect flat or non-polypoid lesions that are often missed during standard colonoscopy. Participants will be randomly assigned to receive either 3D colonoscopy using a specialized 3D imaging device or traditional 2D colonoscopy. The study involves multiple centers and uses a double-blind design, ensuring unbiased results. The main focus is on adenoma detection within 30 minutes of the procedure, with additional measures including detection rates of flat adenomas, proximal adenomas, sessile serrated lesions, advanced adenomas, polyps, and counts of adenomas and polyps per colonoscopy. During the study, participants will undergo colonoscopy examinations with either the 3D or 2D method. Researchers will monitor adenoma detection and related outcomes during the procedure. The trial is sponsored by National Taiwan University Hospital and aims to provide detailed comparisons of colonoscopy quality indicators. The study is planned to start in January 2024 and continue until February 2027.
CONDITIONS
Brief Title
Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Positive Fecal Immunochemical Test Group
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who are 40 years of older
- Subjects who have positive fecal immunochemical test
You will not qualify if you...
- Contraindication for colonoscopy
- Subjects with familiar or hereditary polyposis
- Subjects with history of colectomy
- Inadequate bowel cleansing level
- Subjects with inflammatory bowel disease
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 - 30 minutes
Participants undergo either conventional 2D colonoscopy or 3D colonoscopy to detect adenomas and polyps.
1 visit (in-person)
Trial Site Locations
Total: 3 locations
1
National Taiwan University Hospital, Hsinchu Branch
Hsinchu, Taiwan, Taiwan
Actively Recruiting
2
National Taiwan University Cancer Center
Taipei, Taiwan, Taiwan
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3
National Taiwan University Hospital
Taipei, Taiwan, Taiwan
Actively Recruiting
Research Team
H
Hsuan-Ho Lin, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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