Effect of AI Monitoring Blind Spots of EGD on the Inspection Time and Lesion Dection Rate

NCT ID: NCT05832411

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1672 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-08-31

Brief Summary

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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.

Detailed Description

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The goal of this clinic trial is to evaluate the effect of real-time artificial intelligence for monitoring blind spots on the inspection time of 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 in the case of non-inferior detection rate of gastric neoplastic lesions.

Conditions

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Upper Gastrointestinal Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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AI group

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.

Group Type EXPERIMENTAL

Endoangle

Intervention Type DEVICE

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

Routine group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Endoangle

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. patients with absolute contraindications to EGD examination
2. patients with a history of previous gastrectomy
3. patients with a serious underlying disease
4. pregnant patients
5. researchers believe that the patient is not suitable to participate in the trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 30858305 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34547254 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27548885 (View on PubMed)

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.

Reference Type DERIVED
PMID: 40125855 (View on PubMed)

Other Identifiers

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EA-23-005

Identifier Type: -

Identifier Source: org_study_id

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