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Status unknownNCT05832411Updated Jun 22, 2023

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

An interventional study of Endoangle in Upper Gastrointestinal Symptoms, sponsored by Renmin Hospital of Wuhan University. Status unknown. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-22.

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

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
1,672
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Upper Gastrointestinal Symptoms

Keywords

  • Esophagogastroduodenoscopy
  • Artificial intelligence
  • Blind spot
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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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
1,672 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Endoangle

  • No intervention
    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.

Interventions

  • DeviceEndoangle

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

06

What researchers measure

Primary outcomes

  1. Dection rate of neoplastic lesions

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

    Time frame: Through study completion, an average of 1 year

Secondary outcomes

  1. Inspection time

    It is the time from intubation to extubation of the patient without biopsy.

    Time frame: 20min

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 30858305 ↗
  • 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. PubMed 34547254 ↗
  • 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. PubMed 27548885 ↗

Individual participant data

Plan to share: No — 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05832411
Lead sponsor
Renmin Hospital of Wuhan University
Responsible party
Sponsor
First posted
Apr 27, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
May 31, 2024 (estimated)
Completion
Aug 31, 2024 (estimated)
Last update
Jun 22, 2023

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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