Artificial Intelligence-assisted System in Colonoscopy

Recruiting

• Conditions: Adenoma Colon Polyp
• Interventions: Device: ANDOANGEL

• Registration Number: NCT06406062
• Lead Sponsor: Renmin Hospital of Wuhan University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-05-05
• Study First Posted: 2024-05-09
• Study Start: 2024-05-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-12-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AI-assisted group	ANDOANGEL	Group with AI assistance

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	During Endoscopy procesure	The numerator is the number of patients who had at least one adenoma on colonoscopy, and the denominator is the total number of patients who underwent colonoscopy

Secondary Outcome Measures

Name	Time	Method
Detection rate of serrated adenoma	During Endoscopy procesure	The numerator is the number of patients who had at least one serrated adenoma on colonoscopy, and the denominator is the total number of patients who underwent colonoscopy
Average number of polyps per colonoscopy	During Endoscopy procesure	The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of colonoscopies
Proportion of over-speed frames	During Endoscopy procesure
Polyp detection rate	During Endoscopy procesure	The numerator is the number of patients who had at least one polyp on colonoscopy, and the denominator is the total number of patients who underwent colonoscopy
Colonoscopy time	During Endoscopy procesure	The pure negative time of the whole examination did not include the time of endoscopy entry and the time of biopsy

Trial Locations

Locations (1)

Renmin Hospital of Wuhan Univercity; 🇨🇳 Wuhan, Hubei, China