Artificial Intelligence-assisted Colonoscopy on Detection of Missed

Status Completed

Clinical Trial Summary

This is a prospective multi-center randomized study is to determine whether the use of artificial intelligence (AI)-assistance could reduce the miss rates of polyps and adenomas in the proximal colon during tandem examination

Clinical Trial Description

Centers 1. Queen Mary Hospital, Hong Kong, China (Co-ordinating Center) 2. Tan Tock Seng Hospital, Singapore, Singapore 3. Institute of Gastroenterology and Hepatology, Vietnam Union of Science and Technology Association, Hanoi, Vietnam Study population Inclusion: All adult patients, aged 40 or above, undergoing outpatient colonoscopy in the participating centers will be recruited. Exclusion: - history of inflammatory bowel disease - history of colorectal cancer - previous bowel resection (apart from appendectomy) - Peutz-Jeghers syndrome, familial adenomatous polyposis or other polyposis syndromes - bleeding tendency or severe comorbid illnesses for which polypectomy is considered unsafe. Post-randomization exclusion: - Cecum could not be intubated for various reasons - Boston Bowel Preparation Scale (BBPS) score of the proximal colon is <2 Study design This is a prospective randomized trial comparing the miss rates of proximal colonic lesions by AI assisted colonoscopy or conventional colonoscopy (Fig. 1). The study will be conducted in the Endoscopy Centre of the participating hospitals. Randomization Eligible patients in each center will be randomly allocated in a 1:1 ratio to undergo tandem colonoscopy of the proximal colon first with AI-assistance and follow by conventional white light colonoscopy (Group 1) or conventional white light colonoscopy without AI assistance follow by conventional colonoscopy (Group 2). Proximal colon refers to colonic segment proximal to the splenic flexure. Randomization will be conducted in blocks of 4 by computer generated random sequences and stratified according to indications of colonoscopy (symptomatic vs screening/surveillance). Patients will be blinded to the group assignment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04294355
Study type	Interventional
Source	The University of Hong Kong
Contact
Status	Completed
Phase	N/A
Start date	March 1, 2021
Completion date	April 15, 2022

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Artificial Intelligence-assisted Colonoscopy on Detection of Missed Proximal Lesions

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms