Artificial Intelligence-assisted System in Colonoscopy

NCT ID: NCT06406062

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-20

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Adenoma Colon Polyp

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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AI-assisted group

Group with AI assistance

ANDOANGEL

Intervention Type DEVICE

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.

Control group

Group without AI assistance

No interventions assigned to this group

Interventions

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ANDOANGEL

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renmin Hospital of Wuhan Univercity

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Honggang Yu, Doctor

Role: CONTACT

18771146096

Facility Contacts

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Yu Honggang, Doctor

Role: primary

1371281899

Other Identifiers

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2024K-K017

Identifier Type: -

Identifier Source: org_study_id

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