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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Third Xiangya Hospital of Central South University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Mediastinal lesions have previously undergone surgery or radiotherapy and chemotherapy;

Mental illness, drug addiction, inability to express themselves or other diseases that may affect follow-up.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Artificial intelligence device

    Device

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

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: AI-assisted groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The completeness for standard station scanning

The primary outcome measure was the completeness for standard station scanning of EUS by endoscopists in the two groups. This was calculated as the number of stations successfully scanned divided by the total number of stations that should have been scanned.

Time frame
1 year

Secondary outcomes

1

The completeness of anatomical structure scanning

It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned.

Time frame
1 year
2

Procedure time

It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.

Time frame
1 year
3

The incidence of adverse events

The incidence of adverse events in both groups during the entire research process.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Third Xiangya Hospital of Central South University

Lead sponsor

ZhuZhou Central Hospital

Collaborator

The First Affiliated Hospital of University of South China

Collaborator

The First People's Hospital of Chenzhou

Collaborator

the Affiliated Nanhua Hospital, University of South China

Collaborator