Clinical Research on a Novel Deep-learning Based System in Mediastinal Endoscopic Ultrasound Scanning

March 10, 2025 updated by: The Third Xiangya Hospital of Central South University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiaoyan Wang, Doctor
  • Phone Number: +8613974889301
  • Email: wxy20011@163.com

Study Contact Backup

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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:

  1. Poor physical condition, including hemoglobin ≤8.0g/dl, severe cardiopulmonary insufficiency, etc.
  2. Anesthesia assessment failed
  3. Pregnancy or breastfeeding
  4. In the acute stage of chemical and corrosive injury, it is very easy to cause perforation
  5. Recent acute coronary syndrome or clinically unstable ischemic heart attack
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AI-assisted group
Subjects will undergo EUS examination with the assistance of AI system.
Device: AI system
Patients will undergo EUS examination with the assistance of AI system.
No Intervention: non-assisted group
Subjects will undergo EUS examination without the assistance of AI system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy
Time Frame: 1 year
The number of correctly classified images divided by the total number of images.
1 year
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.
Until the end of the study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cohen's kappa coefficient
Time Frame: 1 year
This data is to evaluate the agreement between the model and the endoscopists.
1 year
The completeness for standard stations and anatomical landmarks per individual
Time Frame: Until the end of the study
The completeness of stations and anatomic landmarks of endoscopic ultrasonography by different endoscopists in the AI system assisted group and the control group were compared.
Until the end of the study
The completeness of anatomical landmarks
Time Frame: Until the end of the study
It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned
Until the end of the study
Operation time
Time Frame: Until the end of the study
In addition to puncture, elastography, and ultrasound enhancement to observe the lesion or treatment, it can also be used to observe the time of the mediastinum.
Until the end of the study
The incidence of adverse events
Time Frame: Until the end of the study
The incidence of adverse events in both groups during the entire research process.
Until the end of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Investigators

  • Principal Investigator: Xiaoyan Wang, Doctor, The Third Xiangya Hospital of Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

April 10, 2025

Study Registration Dates

First Submitted

March 17, 2023

First Submitted That Met QC Criteria

March 29, 2023

First Posted (Actual)

March 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 10, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-EUS-AI-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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