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NCT Number: NCT05863208

Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

E-DA Hospital

Kaohsiung City, 82445, Taiwan

Location status: Recruiting

Location contact

Ying Nan Tsai, M.D

CONTACT

[email protected]

886-7-6150011 ext. 252294

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • A prior history of of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes
  • Bleeding tendency
  • For scheduled endoscopic treatment

Treatment and study plan

Artificial intelligence

Device

ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma

Endocuff vision

Device

Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma

High-definition endoscope

Device

High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma

Primary outcomes

  1. Adenoma detection rate

    Time frame: One month after colonoscopy

    The proportion of patients with at least one adenomas

Secondary outcomes

  1. Polyp detection rate

    Time frame: One month after colonoscopy

    The proportion of patients with at least one polyp

  2. Sessile serrated adenoma detection rate

    Time frame: One month after colonoscopy

    The proportion of patients with at least one sessile serrated adenoma

  3. Sessile serrated polyps detection rate

    Time frame: One month after colonoscopy

    The proportion of patients with at least one sessile serrated polyp

  4. Advanced adenoma detection rate

    Time frame: One month after colonoscopy

    The proportion of patients with at least one advanced adenoma

  5. Mean number of polyp per patient

    Time frame: One month after colonoscopy

    The mean number of polyp per patient

  6. Mean number of adenoma per patient

    Time frame: One month after colonoscopy

    The mean number of adenoma per patient

  7. Total number of polyp or adenoma per patient

    Time frame: One month after colonoscopy

    The total number of polyp or adenoma per patient

Study contacts

Contact information is provided by the study sponsor or research team.

Wen-Lun Wang, Ph.D

CONTACT

[email protected]

+88676150022 ext. 251346

Ying Nan Tsai, MD

CONTACT

[email protected]

+88676150022 ext. 252294

Sponsors and collaborators

Lead sponsor

E-DA Hospital

Other

Collaborators

  • Chung Shan Medical University

Registry information

Official study title

Comparison of The Adenoma Detection Rate Between Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision and Standard Colonscopy: A Randomized Controlled Study

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
May 17, 2023
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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