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Clinical Trials/NCT05792280
NCT05792280
Recruiting
Not Applicable

Clinical Research on Navigation and Quality Control System of Mediastinal Ultrasound Endoscopy Based on Deep Learning

The Third Xiangya Hospital of Central South University1 site in 1 country180 target enrollmentJanuary 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Mediastinum Disease
Sponsor
The Third Xiangya Hospital of Central South University
Enrollment
180
Locations
1
Primary Endpoint
Accuracy
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

The goal of this clinical trial is to develop and verify the auxiliary role of the artificial intelligence system in mediastinal ultrasound endoscopic scanning. The main questions it aims to answer are as follows: 1.The comparison of the image recognition accuracy between the artificial intelligence system and the ultrasound endoscopist; 2. Whether the artificial intelligence system can improve the integrity and efficiency of the mediastinum scanning for the ultrasound endoscopist. Participants will undergo mediastinal EUS with or without the assistance of the artificial intelligence system.

Detailed Description

In this study, a total of 200 cases of mediastinal endoscopic ultrasound scanning videos will be collected. First of all, an artificial intelligence system based on deep learning for the navigation and quality control of mediastinal endoscopic ultrasonography will be established. Secondly, the artificial intelligence system will be used to identify the site and anatomical structure of the mediastinal ultrasound endoscope, and the results of the artificial intelligence system's station recognition will be compared with the results of the endoscopist's station recognition. Finally, the completeness of standard sites and scanning time of endoscopic-assisted and non-assisted AI systems were compared.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
April 10, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Age ≥18 years old, \<80 years old 2.Patients who need endoscopic ultrasonography;
  • 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:

Outcomes

Primary Outcomes

Accuracy

Time Frame: 1 year

The number of correctly classified images divided by the total number of images.

The completeness for standard station scanning

Time Frame: Until the end of the study

This was calculated as the number of stations successfully scanned divided by the total number of stations that should have been scanned.

Secondary Outcomes

  • The incidence of adverse events(Until the end of the study)
  • Cohen's kappa coefficient(1 year)
  • The completeness for standard stations and anatomical landmarks per individual(Until the end of the study)
  • The completeness of anatomical landmarks(Until the end of the study)
  • Operation time(Until the end of the study)

Study Sites (1)

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