NCT04682821

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

December 20, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

December 20, 2020

Last Update Submit

October 23, 2021

Conditions

GastroscopyTrainingArtificial Intelligence

Outcome Measures

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.

    three month

Secondary Outcomes (4)

  • Coverage rate of blind spots in gastroscopy

    three month

  • Check the average test score before and after training

    three month

  • Training satisfaction

    three month

  • Detection rate of lesions

    three month

Study Arms (2)

with Artificial intelligence assistant system

EXPERIMENTAL

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

without Artificial intelligence assistant system

NO INTERVENTION

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

Artificial intelligence assistant systemOTHER

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.

with Artificial intelligence assistant system

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females who are over 18 years old;
  • After qualified medical education and obtained the Certificate of Chinese medical practitioner;

You may not qualify if:

  • A doctor who has already been trained in gastroenteroscopy;
  • Doctors without qualified medical education and didn't obtaine the Certificate of Chinese medical practitioner;
  • The researcher believes that the subjects are not suitable for participating in clinical trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Renmin Hospital of Wuhan University

Wuhan, 430060, China

Location

Related Publications (1)

  • 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.

    PMID: 34970565DERIVED

Study Officials

  • Honggang W Yu, Doctor

    Renmin Hospital of Wuhan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2020

First Posted

December 24, 2020

Study Start

December 23, 2020

Primary Completion

May 25, 2021

Study Completion

June 26, 2021

Last Updated

October 26, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)