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Trial Title: Artificial Intelligence-assisted Colonoscopy With or Without Endocuff Vision

NCT ID: NCT05863208

Condition: Adenoma Detection Rate

Conditions: Official terms:
Adenoma

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Diagnostic

Masking: Single (Participant)

Intervention:

Intervention type: Device
Intervention name: Artificial intelligence
Description: ASUS EndoAim AI Endoscopy System (ASUS, Taiwan) is used to help the detection of colon adenoma
Arm group label: Artificial Intelligence-assisted Colonoscopy
Arm group label: Artificial Intelligence-assisted Colonoscopy with Endocuff Vision

Intervention type: Device
Intervention name: Endocuff vision
Description: Endocuff vision (Olympus, UK) is used to help the detection of colon adenoma
Arm group label: Artificial Intelligence-assisted Colonoscopy with Endocuff Vision

Intervention type: Device
Intervention name: High-definition endoscope
Description: High-definition endoscope (EVIS-EXERA 290 video system, Olympus Optical, Aizu, Japan) is used under white light for the detection of colon adenoma
Arm group label: Artificial Intelligence-assisted Colonoscopy
Arm group label: Artificial Intelligence-assisted Colonoscopy with Endocuff Vision
Arm group label: Standard colonoscopy

Summary: 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.

Detailed description: 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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: E-DA Hospital

Address:
City: Kaohsiung City
Zip: 82445
Country: Taiwan

Status: Recruiting

Contact:
Last name: Ying Nan Tsai, M.D

Phone: 886-7-6150011

Phone ext: 252294
Email: littlepig9933@gmail.com

Start date: May 2, 2023

Completion date: December 31, 2026

Lead sponsor:
Agency: E-DA Hospital
Agency class: Other

Collaborator:
Agency: Chung Shan Medical University
Agency class: Other

Source: E-DA Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05863208

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