NCT05832411

Brief Summary

The goal of this clinic trial is to learn about the effect of AI monitoring blind spots on the inspection time to EGD. Patients are randomly assigned to undergo an EGD with or without the assistance of AI. In the AI group, except for the original videos, there is additional information presented to endoscopists:(1)the virtual stomach model monitoring;(2)time;(3)scoring. Researchers will compare intervention group to see if it have a shorter inspection time compared with the control group.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,672

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

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

First Submitted

Initial submission to the registry

April 3, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

June 22, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

April 3, 2023

Last Update Submit

June 16, 2023

Conditions

Upper Gastrointestinal Symptoms

Keywords

EsophagogastroduodenoscopyArtificial intelligenceBlind spot

Outcome Measures

Primary Outcomes (1)

  • Dection rate of neoplastic lesions

    Proportion of patients with neoplastic lesions among all patients undergoing esophagogastroduodenoscopy.

    Through study completion, an average of 1 year

Secondary Outcomes (1)

  • Inspection time

    20min

Study Arms (2)

AI group

EXPERIMENTAL

In the AI group, except for the original videos, there is additional information presented to endoscopists:（1）the virtual stomach model monitoring;（2）time;（3）scoring. Endoscopists will complete EGD examination without blind spots.

Device: Endoangle

Routine group

NO INTERVENTION

In the Routine group, only the original videos and there is no additional information, and inspection time will be no less than 7 minutes.

Interventions

EndoangleDEVICE

there is additional information presented to endoscopists:（1）the virtual stomach model monitoring；（2）time;（3）scoring.

AI group

Eligibility Criteria

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

You may qualify if:

  • patients aged 18 years or older
  • patients able to give informed consent
  • American Society of Anesthesiology risk class 1,2 or 3

You may not qualify if:

  • patients with absolute contraindications to EGD examination
  • patients with a history of previous gastrectomy
  • patients with a serious underlying disease
  • pregnant patients
  • researchers believe that the patient is not suitable to participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Wu L, Zhang J, Zhou W, An P, Shen L, Liu J, Jiang X, Huang X, Mu G, Wan X, Lv X, Gao J, Cui N, Hu S, Chen Y, Hu X, Li J, Chen D, Gong D, He X, Ding Q, Zhu X, Li S, Wei X, Li X, Wang X, Zhou J, Zhang M, Yu HG. Randomised controlled trial of WISENSE, a real-time quality improving system for monitoring blind spots during esophagogastroduodenoscopy. Gut. 2019 Dec;68(12):2161-2169. doi: 10.1136/gutjnl-2018-317366. Epub 2019 Mar 11.

    PMID: 30858305BACKGROUND

  • Wu L, Xu M, Jiang X, He X, Zhang H, Ai Y, Tong Q, Lv P, Lu B, Guo M, Huang M, Ye L, Shen L, Yu H. Real-time artificial intelligence for detecting focal lesions and diagnosing neoplasms of the stomach by white-light endoscopy (with videos). Gastrointest Endosc. 2022 Feb;95(2):269-280.e6. doi: 10.1016/j.gie.2021.09.017. Epub 2021 Sep 20.

    PMID: 34547254BACKGROUND

  • Bisschops R, Areia M, Coron E, Dobru D, Kaskas B, Kuvaev R, Pech O, Ragunath K, Weusten B, Familiari P, Domagk D, Valori R, Kaminski MF, Spada C, Bretthauer M, Bennett C, Senore C, Dinis-Ribeiro M, Rutter MD. Performance measures for upper gastrointestinal endoscopy: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2016 Sep;48(9):843-64. doi: 10.1055/s-0042-113128. Epub 2016 Aug 22. No abstract available.

    PMID: 27548885BACKGROUND

  • Tan X, Yao L, Dong Z, Li Y, Yu Y, Gao X, Zhu K, Su W, Yin H, Wang W, Luo C, Li J, You H, Hu H, Zhou W, Yu H. Artificial Intelligence as a Surrogate for Inspection Time to Assess Completeness in Esophagogastroduodenoscopy: A Prospective, Randomized, Noninferiority Study. Clin Transl Gastroenterol. 2025 Mar 25;16(6):e00839. doi: 10.14309/ctg.0000000000000839. eCollection 2025 Jun 1.

    PMID: 40125855DERIVED

MeSH Terms

Conditions

Scotoma

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2023

First Posted

April 27, 2023

Study Start

July 1, 2023

Primary Completion

May 31, 2024

Study Completion

August 31, 2024

Last Updated

June 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Sponsor approval for data sharing should be sought; Data access requests should be made via an application form detailing the specific requirements and the proposed research and publication plan