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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06406062
Other study ID # 2024K-K017
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT03279783 - LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon N/A
Completed NCT03775811 - In Vivo Computer-aided Prediction of Polyp Histology on White Light Colonoscopy