NCT05479253

Brief Summary

In this study, we proposed a prospective study about the effectiveness of artificial intelligence system for endoscopy report quality in endoscopists. The subjects would be divided into two groups. For the collected endoscopic videos, group A would complete the endoscopy report with the assistance of the artificial intelligence system. The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the upper gastrointestinal tract is divided into 26 parts). Group B would complete the endoscopy report without special prompts. After a period of forgetting, the two groups switched, that is, group A without AI assistance and group B with AI assistance to complete the endoscopy report. Then, the completeness of the report lesion, the accuracy of the lesion location, the completeness of the lesion and the standard part in the captured images, and so on were compared with or without AI assistance.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 10, 2022

Status Verified

July 1, 2022

Enrollment Period

1.1 years

First QC Date

July 27, 2022

Last Update Submit

August 8, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Integrity of report lesion

    Report lesion integrity with or without AI-assisted. Calculation method = number of report lesions / total number of lesions x 100%

    one month

  • Accuracy of lesion location

    Accuracy of lesion location with or without AI-assisted. Calculation method = number of lesion with correct location / total number of lesions x 100%

    one month

  • Integrity of lesion in captured images

    Lesion integrity in captured images with or without AI-assisted. Calculation method = number of lesions in captured images / total number of lesions x 100%

    one month

  • Integrity of standard part in captured images

    Lesion integrity in captured images with or without AI-assisted. Calculation method = number of standard parts in captured images / the actual number of standard parts covered by the examination x 100%

    one month

Study Arms (2)

with Artificial intelligence assistant system

EXPERIMENTAL

Endoscopists would complete the endoscopy report with the assistance of the artificial intelligence system.

Diagnostic Test: Artificial intelligence assistant system

without Artificial intelligence assistant system

NO INTERVENTION

Endoscopists would complete the endoscopy report without special prompts.

Interventions

The artificial intelligence assistant system can automatically capture images, prompt abnormal lesions and the parts covered by the examination (the stomach is divided into 26 parts).

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:

  • 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

RECRUITING

Related Publications (1)

  • Zhang L, Lu Z, Yao L, Dong Z, Zhou W, He C, Luo R, Zhang M, Wang J, Li Y, Deng Y, Zhang C, Li X, Shang R, Xu M, Wang J, Zhao Y, Wu L, Yu H. Effect of a deep learning-based automatic upper GI endoscopic reporting system: a randomized crossover study (with video). Gastrointest Endosc. 2023 Aug;98(2):181-190.e10. doi: 10.1016/j.gie.2023.02.025. Epub 2023 Feb 25.

Central Study Contacts

Honggang Yu, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2022

First Posted

July 29, 2022

Study Start

November 1, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

August 10, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations