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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Mediastinal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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AI-assisted group

Endoscopists perform scans with the assistance of AI device.

Group Type EXPERIMENTAL

Artificial intelligence device

Intervention Type DEVICE

This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.

Control group

Endoscopists perform scans without the assistance of AI device.

Group Type PLACEBO_COMPARATOR

Artificial intelligence device

Intervention Type DEVICE

This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.

Interventions

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Artificial intelligence device

This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes