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CompletedNCT04682821Updated Oct 26, 2021

The Research of AI Assistant Gastroscope Training

An interventional study of Artificial intelligence assistant system in Gastroscopy, Training and Artificial Intelligence, sponsored by Renmin Hospital of Wuhan University. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-26.

Sponsored by Renmin Hospital of Wuhan University · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
288
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Gastroscopy
  • Training
  • Artificial Intelligence
03

In context

Lead sponsor

Renmin Hospital of Wuhan University is the lead sponsor of 83 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Novice endoscopists:

Inclusion criteria

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 criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
288 participants (actual)

Study arms

  • 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

  • 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.

Interventions

  • OtherArtificial 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: three month

Secondary outcomes

  1. 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%.

    Time frame: three month

  2. 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.

    Time frame: three month

  3. Training satisfaction

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

    Time frame: three month

  4. 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%.

    Time frame: three month

07

Study locations

1 site
  • Renmin Hospital of Wuhan University
    Wuhan, 430060, China
08

References and documents

Publications

  • Huang L, Liu J, Wu L, Xu M, Yao L, Zhang L, Shang R, Zhang M, Xiong Q, Wang D, Dong Z, Xu Y, Li J, Zhu Y, Gong D, Wu H, Yu H. Impact of Computer-Assisted System on the Learning Curve and Quality in Esophagogastroduodenoscopy: Randomized Controlled Trial. Front Med (Lausanne). 2021 Dec 14;8:781256. doi: 10.3389/fmed.2021.781256. eCollection 2021. PubMed 34970565 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04682821
Lead sponsor
Renmin Hospital of Wuhan University
Responsible party
Sponsor
First posted
Dec 24, 2020
Start date
Dec 23, 2020
Primary completion
May 25, 2021
Completion
Jun 26, 2021
Last update
Oct 26, 2021

Study contacts

Honggang W Yu, Doctor
principal investigator · Renmin Hospital of Wuhan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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