Artificial Intelligence-assisted System in Colonoscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ANDOANGEL.
- Who it may be relevant to
- Registry conditions: Adenoma Colon Polyp. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Obsevational Multicenter Study
Overview
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
- 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.
Primary outcome measures
- Adenoma detection rate [Time frame: During Endoscopy procesure]
Secondary outcome measures (5)
- Polyp detection rate [Time frame: During Endoscopy procesure]
- Detection rate of serrated adenoma [Time frame: During Endoscopy procesure]
- Average number of polyps per colonoscopy [Time frame: During Endoscopy procesure]
- Colonoscopy time [Time frame: During Endoscopy procesure]
- Proportion of over-speed frames [Time frame: During Endoscopy procesure]
Eligibility criteria
Inclusion criteria
- age > 50 years old;
- required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy;
- voluntarily sign informed consent;
- Commitment to abide by the study procedures and cooperate with the implementation of the whole process of the study.
Exclusion criteria
- have participated in other clinical trials, signed informed consent and are in the follow-up period of other clinical trials;
- known polyposis syndrome patients;
- patients with known IBD;
- patients considered by the investigators to be unsuitable or unable to undergo complete digestive endoscopy and related examinations;
- high-risk diseases or other special conditions considered by the investigator to be unsuitable for clinical trial participation.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Renmin Hospital of Wuhan Univercity — Wuhan
Identifiers
NCT: NCT06406062 · 2024K-K017