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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04682821
Other study ID # EA-19-003-19
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 23, 2020
Est. completion date June 26, 2021

Study information

Verified date December 2020
Source Renmin Hospital of Wuhan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for gastroscope training in novice endoscopists. The subjects would be divided into two groups. The experimental group would be trained in painless gastroscopy with the assistance of the artificial intelligence assistant system. The artificial intelligence assistant system can prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts). The control group would receive routine painless gastroscopy training without special prompts. Then we compare the gastroscopy operation score, coverage rate of blind spots in gastroscopy,check the average test score before and after training, training satisfaction, detection rate of lesions and so on between the two group.


Description:

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for gastroscope training in novice endoscopists. The subjects would be divided into two groups. The experimental group would be trained in painless gastroscopy with the assistance of the artificial intelligence assistant system. The artificial intelligence assistant system can prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts). The control group would receive routine painless gastroscopy training without special prompts. Then we compare the gastroscopy operation score, coverage rate of blind spots in gastroscopy,check the average test score before and after training, training satisfaction, detection rate of lesions and so on between the two group.


Recruitment information / eligibility

Status Completed
Enrollment 288
Est. completion date June 26, 2021
Est. primary completion date May 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Novice endoscopists: Inclusion Criteria: 1. Males or females who are over 18 years old; 2. After qualified medical education and obtained the Certificate of Chinese medical practitioner; Exclusion Criterial: 1. A doctor who has already been trained in gastroenteroscopy; 2. Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner; 3. The researcher believes that the subjects are not suitable for participating in clinical trials.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Artificial intelligence assistant system
The intervention is the use of the artificial intelligence assistant system in addition to the common training. The system is an non-invasive AI system which could help the endoscopists to diagnosis and monitor the blind spot during the gastroscope.

Locations

Country Name City State
China Renmin Hospital of Wuhan University Wuhan

Sponsors (1)

Lead Sponsor Collaborator
Renmin Hospital of Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastroscopy operation score Using a professional gastroscopy operation scoring scale, the full score is 100 points, and the score is divided into small items. In this experiment, the effect of training between the two groups was compared by comparing the scores of gastroscopy operation in the experimental group and the control group. three month
Secondary Coverage rate of blind spots in gastroscopy Evaluate the gastroscope operation videos retained by each physician during the examination, and calculate the coverage of 26 parts of the gastric mucosa in the experimental group and the control group during the examination. The calculation method is: the coverage rate of the blind area of the gastroscopy = the actual number of parts covered by the examination/26 parts of the stomach x 100%. three month
Secondary Check the average test score before and after training the difference between the theoretical test score after the training and the theoretical test score before the training, the calculation method: the theoretical test score after the training-the theoretical test score before the training. three month
Secondary Training satisfaction An AI assistant group fills out a questionnaire after training, and determines the satisfaction with AI assistant training through a grading method. three month
Secondary Detection rate of lesions the detection rate of lesions in the experimental group and the control group by gastroscopy. Calculation method = number of gastroscopes with detected lesions/total number of gastroscopes completed by beginner physicians x 100%. three month
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