A Study on the Effectiveness of AI-assisted Colonoscopy in Improving the Effect of Colonoscopy Training for Trainees
1 other identifier
interventional
385
1 country
1
Brief Summary
In this study,the AI-assisted system（EndoAngel）has the functions of reminding the ileocecal junction, withdrawal time, withdrawal speed, sliding lens, polyps in the field of vision, etc. These functions can improve the colonoscopy performance of novice physicians and assist the colonoscopy training。
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2021
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2022
CompletedJune 3, 2021
May 1, 2021
7 months
May 28, 2021
May 28, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
CUSUM learning curve for colonoscopy (ACE scoring scale)
From the beginning to the end of colonoscopy training
Average test score difference before and after training
From the beginning to the end of colonoscopy training
Secondary Outcomes (14)
Detection rate of advanced adenoma
A month
Polyp Detection Rate, PDR
A month
Average number of adenomas detected per patient
A month
The detection rate of large, small and micro polyps
A month
The average number of large, small and micro polyps detected
A month
- +9 more secondary outcomes
Study Arms (2)
with AI-assisted system
EXPERIMENTALThe novice doctors are trained in colonoscopy with an artificial intelligence assisted system that can indicate abnormal lesions and the speed of withdrawal in real time, as well as feedback on the percentage of overspeed.
without AI-assisted system
NO INTERVENTIONThe novice doctors receive routine colonoscopy training without artificial intelligence assistance system and no special tips
Interventions
the artificial intelligence assistance system can indicate abnormal lesions and real-time withdrawal speed, and feedback the overspeed percentage.
Eligibility Criteria
You may qualify if:
- Male or female ≥50 years old;
- Able to read, understand and sign informed consent
- The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures
- Patients requiring colonoscopy
You may not qualify if:
- Have drug or alcohol abuse or mental disorder in the last 5 years
- Pregnant or lactating women
- Patients with known multiple polyp syndrome;
- patients with known inflammatory bowel disease;
- known intestinal stenosis or space-occupying tumor;
- known colon obstruction or perforation;
- patients with a history of colorectal surgery;
- Patients with previous history of allergy to pre-used spasmolysis;
- Unable to perform biopsy and polyp removal due to coagulation disorders or oral anticoagulants;
- High risk diseases or other special conditions that the investigator considers the subject unsuitable for participation in the clinical trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renmin hospital of Wuhan University
Wuhan, Hubei, 430000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu w Honggang, Doctor
Renmin Hospital of Wuhan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2021
First Posted
June 3, 2021
Study Start
June 1, 2021
Primary Completion
January 1, 2022
Study Completion
February 1, 2022
Last Updated
June 3, 2021
Record last verified: 2021-05