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
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Renmin Hospital of Wuhan Univercity | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Renmin Hospital of Wuhan University |
China,
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 |
Status | Clinical Trial | Phase | |
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Recruiting |
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