Artificial Intelligence-assisted System in Colonoscopy

Adenoma Colon Polyp Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06406062
• Other study ID #: 2024K-K017
• Status: Not yet recruiting
• Start date: May 20, 2024
• Est. completion date: December 30, 2025

Study information

• Verified date: February 2024
• Source: Renmin Hospital of Wuhan University
• Contact: Honggang Yu, Doctor
• Phone: 18771146096
• Email: wjlnsm[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: December 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon Polyp

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Renmin Hospital of Wuhan Univercity	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	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	During Endoscopy procesure
Secondary	Polyp detection rate	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	During Endoscopy procesure
Secondary	Detection rate of serrated adenoma	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	During Endoscopy procesure
Secondary	Average number of polyps per colonoscopy	The numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of colonoscopies	During Endoscopy procesure
Secondary	Colonoscopy time	The pure negative time of the whole examination did not include the time of endoscopy entry and the time of biopsy	During Endoscopy procesure
Secondary	Proportion of over-speed frames		During Endoscopy procesure