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

Not Applicable

Not yet recruiting

• Conditions: Upper Gastrointestinal Symptoms
• Interventions: Device: Endoangle

• Registration Number: NCT05832411
• Lead Sponsor: Renmin Hospital of Wuhan University

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-26
• Study First Posted: 2023-04-27
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-22
• Study Start: 2023-07-01
• Primary Completion: 2024-05-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1672

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AI group	Endoangle	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.

Primary Outcome Measures

Name	Time	Method
Dection rate of neoplastic lesions	Through study completion, an average of 1 year	Proportion of patients with neoplastic lesions among all patients undergoing esophagogastroduodenoscopy.

Secondary Outcome Measures

Name	Time	Method
Inspection time	20min	It is the time from intubation to extubation of the patient without biopsy.