RecruitingNCT06406062

Artificial Intelligence-assisted System in Colonoscopy

To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Obsevational Multicenter Study

Sponsor

Renmin Hospital of Wuhan University

Enrollment

7,500 participants

Start Date

May 20, 2024

Study Type

OBSERVATIONAL

Conditions

Adenoma Colon Polyp

Summary

In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control. This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control. This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study.

Eligibility

Min Age: 50 Years

Inclusion Criteria4

age > 50 years old;
required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy;
voluntarily sign informed consent;
Commitment to abide by the study procedures and cooperate with the implementation of the whole process of the study.

Exclusion Criteria5

have participated in other clinical trials, signed informed consent and are in the follow-up period of other clinical trials;
known polyposis syndrome patients;
patients with known IBD;
patients considered by the investigators to be unsuitable or unable to undergo complete digestive endoscopy and related examinations;
high-risk diseases or other special conditions considered by the investigator to be unsuitable for clinical trial participation.

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Interventions

DEVICEANDOANGEL

Polyps were identified by endoscopists assisted by an AI system: rectangular box marks; Monitoring of ileocecal position: whether blindness was reached was displayed in the lower left corner of the interface. Mirror entry and exit time monitoring: the operation time is displayed in the upper left corner of the interface. Colonoscopy withdrawal speed monitoring: the relative withdrawal speed was displayed on the left side of the interface.