The Research of AI Assistant Gastroscope Training

Sponsor
Renmin Hospital of Wuhan University (Other)
Overall Status
Completed
CT.gov ID
NCT04682821
Collaborator
(none)
288
1
2
6.1
47.4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Artificial intelligence assistant system
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
288 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Screening
Official Title:
The Research of Artificial Intelligence Assistance System Effectiveness for Novice Endoscopists Gastroscopy Training
Actual Study Start Date :
Dec 23, 2020
Actual Primary Completion Date :
May 25, 2021
Actual Study Completion Date :
Jun 26, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: with Artificial intelligence assistant system

The experiment group would receive the training with the help of 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.

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.

No Intervention: without Artificial intelligence assistant system

The control group would receive the training without the help of artificial intelligence assistant system. That is, they would receive the common training process.

Outcome Measures

Primary Outcome Measures

  1. Gastroscopy operation score [three month]

    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.

Secondary Outcome Measures

  1. Coverage rate of blind spots in gastroscopy [three month]

    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%.

  2. Check the average test score before and after training [three month]

    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.

  3. Training satisfaction [three month]

    An AI assistant group fills out a questionnaire after training, and determines the satisfaction with AI assistant training through a grading method.

  4. Detection rate of lesions [three month]

    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%.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Renmin Hospital of Wuhan University Wuhan China 430060

Sponsors and Collaborators

  • Renmin Hospital of Wuhan University

Investigators

  • Principal Investigator: Honggang W Yu, Doctor, Renmin Hospital of Wuhan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Renmin Hospital of Wuhan University
ClinicalTrials.gov Identifier:
NCT04682821
Other Study ID Numbers:
  • EA-19-003-19
First Posted:
Dec 24, 2020
Last Update Posted:
Oct 26, 2021
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Oct 26, 2021