Higher adenoma detection rate with the endocuff: a randomized trial.
Coty González-Fernández, David García-Rangel, Nancy Edith Aguilar-Olivos...
https://pubmed.ncbi.nlm.nih.gov/28898920Actively Recruiting
Led by E-DA Hospital · Updated on 2025-06-27
1000
Participants Needed
1
Research Sites
52 weeks
Total Duration
E
E-DA Hospital
Lead Sponsor
C
Chung Shan Medical University
Collaborating Sponsor
Researchers are investigating how to improve the detection of colon adenomas, which are important for preventing colorectal cancer. This randomized controlled trial compares three types of colonoscopy: one using artificial intelligence (AI) combined with Endocuff vision, one using AI alone, and one using standard colonoscopy. The study focuses on measuring the adenoma detection rate (ADR) to see if combining AI and Endocuff vision offers an advantage. The trial involves three groups assigned equally: the first group receives colonoscopy with AI and Endocuff vision devices; the second group receives AI-assisted colonoscopy alone; the third group undergoes standard colonoscopy without these devices. High-definition endoscopes under white light are used in all procedures. Experienced endoscopists perform the exams, confirming cecal intubation by identifying specific anatomical landmarks. Polyps found are measured, recorded, and removed by biopsy or polypectomy. Participants are adults over 40 undergoing colonoscopy for symptoms or screening at several hospitals. Researchers assess bowel preparation quality, polyp characteristics, and procedure times excluding polypectomy. The main outcome measured one month after colonoscopy is the adenoma detection rate. Secondary outcomes include various polyp detection rates and counts. This study aims to clarify whether combining AI and Endocuff vision improves detection compared to AI alone or standard methods.
CONDITIONS
Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 1 day
Participants undergo one of three types of colonoscopy examinations: Artificial Intelligence-assisted Colonoscopy with Endocuff Vision, Artificial Intelligence-assisted Colonoscopy alone, or Standard Colonoscopy without AI assistance or Endocuff Vision.
1 visit (in-person)
Duration - 1 month
Participants are monitored for adenoma and polyp detection outcomes one month after colonoscopy.
Total: 1 location
1
E-DA Hospital
Kaohsiung City, Taiwan, 82445
Actively Recruiting
Y
Ying Nan Tsai, MD
W
Wen-Lun Wang, Ph.D
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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