An interventional study of Artificial intelligence and Endocuff vision in Adenoma Detection Rate, sponsored by E-DA Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-06-27.
Sponsored by E-DA Hospital · Not applicable, Interventional, and Diagnostic
Adenoma detection rate (ADR) is considered the single most important quality measure in colonoscopy and a higher ADR can reduce the risk of interval colorectal cancer (CRC). Several kinds of new endoscopes and accessories have been accessed to investigate the abilities of improving the ADR. Artificial intelligence (AI) and Endocuff vision are promising new devices to improve the ADR. However, the effect of combining AI and Endocuff vision on ADR remains unclear. The aim of this prospective randomized study is to compare the ADR of AI plus Endocuff vision, AI alone and standard colonoscopy examination.
This is a prospective single-blinded randomized controlled trial of three different types of colonoscopy examinations by 1:1:1 ratio. We use EndoAim AI (ASUS, Taiwan) and Endocuff vision (Olympus, UK) assisted colonoscopy in the first group. We use AI assisted colonoscopy in the 2nd group. We use standard colonoscopy in the 3rd group.
Eligible patients are older than 40 years old and receive colonoscopy for either symptomatic or screening/surveillance. All endoscopists should receive training on EndoAim AI systems and Endocuff vision. During the procedure, experienced endoscopists use high-definition endoscopes (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) under white light and insert to the cecum in the three different groups. The cecal intubation is confirmed by the identification of ileocecal valve and appendiceal orifice.
The Boston Bowel Preparation Scale is used for grading the bowel preparation quality. The size (compared with biopsy forceps), location and morphology of polyps are recorded by the independent endoscopist. All polyps ae removed by either biopsy or polypectomy. The insertion and withdrawal time are measured. The time of the polypectomy site is not included in the withdrawal time.
E-DA Hospital is the lead sponsor of 35 studies on the registry; 8 are open to participants now.
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Patients over 20 years old are undergoing outpatient sedative colonoscopy in the E-Da Hospital, E-Da cancer Hospital and Chung Shan Medical University Hospital in Taiwan
Exclusion Criteria:
Use artificial intelligence-assisted colonoscopy with Endocuff Vision
Device: Artificial intelligence · Device: Endocuff vision · Device: High-definition endoscope
Use artificial intelligence-assisted colonoscopy alone
Device: Artificial intelligence · Device: High-definition endoscope
Use standard colonoscopy without artificial intelligence-assisted colonoscopy or Endocuff Vision
Device: High-definition endoscope
ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma
Adenoma detection rate
The proportion of patients with at least one adenomas
Time frame: One month after colonoscopy
Polyp detection rate
The proportion of patients with at least one polyp
Time frame: One month after colonoscopy
Sessile serrated adenoma detection rate
The proportion of patients with at least one sessile serrated adenoma
Time frame: One month after colonoscopy
Sessile serrated polyps detection rate
The proportion of patients with at least one sessile serrated polyp
Time frame: One month after colonoscopy
Advanced adenoma detection rate
The proportion of patients with at least one advanced adenoma
Time frame: One month after colonoscopy
Mean number of polyp per patient
The mean number of polyp per patient
Time frame: One month after colonoscopy
Mean number of adenoma per patient
The mean number of adenoma per patient
Time frame: One month after colonoscopy
Total number of polyp or adenoma per patient
The total number of polyp or adenoma per patient
Time frame: One month after colonoscopy
Plan to share: No
Started May 2023 (actual). Primary completion is estimated for Dec 2025, 31 months after the start.
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E-DA Hospital