Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID05863208

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

Led by E-DA Hospital · Updated on 2025-06-27

1000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

E

E-DA Hospital

Lead Sponsor

C

Chung Shan Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients over 20 years old undergoing outpatient sedative colonoscopy at participating hospitals
  • Ability to undergo colonoscopy for symptoms, screening, or surveillance
Not Eligible

You will not qualify if you...

  • History of inflammatory bowel disease, colorectal cancer, previous bowel resection, Peutz-Jeghers syndrome, familial adenomatous polyposis, or other polyposis syndromes
  • Bleeding tendency
  • Scheduled for endoscopic treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

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)

Long-term Monitoring

Duration - 1 month

Participants are monitored for adenoma and polyp detection outcomes one month after colonoscopy.

Trial Site Locations

Total: 1 location

1

E-DA Hospital

Kaohsiung City, Taiwan, 82445

Actively Recruiting

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Research Team

Y

Ying Nan Tsai, MD

W

Wen-Lun Wang, Ph.D

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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Published Research Related To This Trial

Endocuff-assisted colonoscopy is associated with a lower adenoma miss rate: a multicenter randomized tandem study.

Konstantinos Triantafyllou, Dimitrios Polymeros, Periklis Apostolopoulos...

https://pubmed.ncbi.nlm.nih.gov/28763808

Effect of Endocuff-assisted colonoscopy on adenoma detection rate: meta-analysis of randomized controlled trials.

Nicolas Williet, Quentin Tournier, Chloé Vernet...

https://pubmed.ncbi.nlm.nih.gov/29698990

Artificial Intelligence-Assisted Colonoscopy for Colorectal Cancer Screening: A Multicenter Randomized Controlled Trial.

Hong Xu, Raymond S Y Tang, Thomas Y T Lam...

https://pubmed.ncbi.nlm.nih.gov/35863686

Performance of artificial intelligence in colonoscopy for adenoma and polyp detection: a systematic review and meta-analysis.

Cesare Hassan, Marco Spadaccini, Andrea Iannone...

https://pubmed.ncbi.nlm.nih.gov/32598963