Clinical trial NCT06406062: Artificial Intelligence-assisted System in Colonoscopy
Official title: To Evaluate the Effectiveness and Safety of an Artificial Intelligence-assisted System in Colonoscopy in a Real-world Obsevational Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adenoma Colon Polyp
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 7500
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Adenoma detection rate
timeFrame: During Endoscopy procesure
Secondary outcomes:
measure: Polyp detection rate
timeFrame: During Endoscopy procesure
measure: Detection rate of serrated adenoma
timeFrame: During Endoscopy procesure
measure: Average number of polyps per colonoscopy
timeFrame: During Endoscopy procesure
measure: Colonoscopy time
timeFrame: During Endoscopy procesure
measure: Proportion of over-speed frames
timeFrame: During Endoscopy procesure
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan Univercity
state: Hubei
Study officials:
References: