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Comparison of the Performance Between Conventional Colonoscopy and 3D Colonoscopy in Surveillance Colonoscopy: A Multi-center, Randomized Controlled Trial
Led by National Taiwan University Hospital · Updated on 2025-07-24
500
Participants Needed
3
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of 3D colonoscopy compared to standard 2D colonoscopy during surveillance colonoscopy in patients aged 40 and older. The study focuses on improving adenoma detection rate (ADR), which is crucial for preventing colorectal cancer and reducing mortality. Detecting non-polypoid lesions, which are often missed by traditional methods, is a key concern as these lesions contribute to post-colonoscopy colorectal cancer. Participants will be randomly assigned to receive either 3D colonoscopy using a specialized 3D imaging device or standard 2D colonoscopy. This multicenter, prospective, randomized controlled trial compares how well each method detects adenomas and polyps during surveillance colonoscopy performed at least one year after prior colonoscopy and polypectomy. During the study, participants will undergo colonoscopy with monitoring of various detection rates, including overall ADR, flat-ADR, proximal and distal ADR, and polyp detection rates. Researchers will assess adenoma numbers per colonoscopy and evaluate safety and quality of bowel preparation. The primary outcome is the adenoma detection rate within 30 minutes. The study includes double masking to reduce bias and will follow participants until February 2027.
CONDITIONS
Brief Title
Comparison of Adenoma Detection Rate in 3D vs. 2D Surveillance Colonoscopy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects who are 40 years of older
- Subjects who receive colonoscopy and polypectomy more the 1 year
- Subjects who need surveillance colonoscopy
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.
1 visit (in-person)
Duration - 1 day
Participants undergo either 3D or 2D colonoscopy as part of surveillance colonoscopy using the assigned colonoscopy device.
1 procedure visit
Duration - 30 minutes
Adenoma detection and related diagnostic assessments are performed during and immediately after the colonoscopy procedure.
1 evaluation visit
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, 100
Actively Recruiting
3
National Taiwan University Hospital
Taipei, Taiwan, Taiwan, 100
Actively Recruiting
Research Team
L
Li-Chun Chang, MD. PhD.
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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