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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Upper Gastrointestinal Symptoms

Intervention / Treatment
-----------------
* Device: Endoangle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients aged 18 years or older patients able to give informed consent American Society of Anesthesiology risk class 1,2 or 3 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AI group<br>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<br>* there is additional information presented to endoscopists:（1）the virtual stomach model monitoring；（2）time;（3）scoring.<br>|
| No Intervention: Routine group<br>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 | 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 | It is the time from intubation to extubation of the patient without biopsy. | 20min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophagogastroduodenoscopy, Artificial intelligence, Blind spot