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

June 16, 2023 updated by: Renmin Hospital of Wuhan University

Effect of Artificial Intelligence Monitoring Blind Spots of EGD on the Inspection Time and Dection Rate of Neoplastic Lesions

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1672

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
there is additional information presented to endoscopists:（1）the virtual stomach model monitoring；（2）time;（3）scoring.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dection rate of neoplastic lesions
Time Frame: Through study completion, an average of 1 year
Proportion of patients with neoplastic lesions among all patients undergoing esophagogastroduodenoscopy.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inspection time
Time Frame: 20min
It is the time from intubation to extubation of the patient without biopsy.
20min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2023

Primary Completion (Estimated)

May 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 3, 2023

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 22, 2023

Last Update Submitted That Met QC Criteria

June 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EA-23-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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