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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06406062
Enrollment
7500
Registered
2024-05-09
Start date
2024-05-20
Completion date
2025-12-30
Last updated
2025-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenoma Colon Polyp

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.

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.

Sponsors

Renmin Hospital of Wuhan University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Adenoma detection rateDuring Endoscopy procesureThe 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

MeasureTime frameDescription
Polyp detection rateDuring Endoscopy procesureThe 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
Detection rate of serrated adenomaDuring Endoscopy procesureThe 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 colonoscopyDuring Endoscopy procesureThe numerator is the total number of polyps detected by colonoscopy, and the denominator is the total number of colonoscopies
Colonoscopy timeDuring Endoscopy procesureThe pure negative time of the whole examination did not include the time of endoscopy entry and the time of biopsy
Proportion of over-speed framesDuring Endoscopy procesure

Countries

China

Contacts

Primary ContactHonggang Yu, Doctor
wjlnsm@163.com18771146096

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026