Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial

Central South University

Status: Enrolling

Conditions: Mediastinal Disease

Treatments: Device: Artificial intelligence device

Study type: Interventional

Funder types: Other

Identifiers

NCT06790108

2023-EUS-AI-002-2

Details and patient eligibility

About

The goal of this clinical trial is to verify the auxiliary role of the artificial intelligence (AI) system in mediastinal endoscopic ultrasound (EUS) scans. The main questions it aims to answer are as follows:

1. A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
2. Whether the AI system can improve the quality of mediastinal scans for EUS endoscopists.

Participants will conduct mediastinal EUS with or without the assistance of the AI system.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Age ≥18 years old, <80 years old 2.Patients who need endoscopic ultrasonography; 3. Agree to participate in this study and sign the informed consent form.

Exclusion criteria

Subjects who meet any of the following criteria cannot be selected for this trial:

First. The patient's physical condition does not meet the requirements of conventional endoscopic ultrasonography:

Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc. Anesthesia assessment failed Pregnancy or breastfeeding In the acute stage of chemical and corrosive injury, it is very easy to cause perforation Recent acute coronary syndrome or clinically unstable ischemic heart attack Heart disease patients with right-to-left shunt, patients with severe pulmonary hypertension (pulmonary artery pressure> 90mmHg), patients with uncontrolled systemic hypertension and patients with adult respiratory distress syndrome.

Second. Disagree to participate in this study.

Third. There are other problems that do not meet the requirements of this research or that affect the results of the research:

1. Mediastinal lesions have previously undergone surgery or radiotherapy and chemotherapy;
2. Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

AI-assisted group

Experimental group

Description:

Endoscopists perform scans with the assistance of AI device.

Treatment:

Device: Artificial intelligence device

Control group

Placebo Comparator group

Description:

Endoscopists perform scans without the assistance of AI device.

Treatment:

Device: Artificial intelligence device