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Recruiting NCT05792280

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

No phase Interventional Mediastinum Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AI system.
Who it may be relevant to
Registry conditions: Mediastinum Disease. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Device AI system
    Patients will undergo EUS examination with the assistance of AI system.

Primary outcome measures

  • Accuracy [Time frame: 1 year]
  • The completeness for standard station scanning [Time frame: Until the end of the study]
Secondary outcome measures (5)
  • Cohen's kappa coefficient [Time frame: 1 year]
  • The completeness for standard stations and anatomical landmarks per individual [Time frame: Until the end of the study]
  • The completeness of anatomical landmarks [Time frame: Until the end of the study]
  • Operation time [Time frame: Until the end of the study]
  • The incidence of adverse events [Time frame: Until the end of the study]

Eligibility criteria

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:

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

China · 1 center
  • The Third Xiangya Hospital of Central South University — Changsha

Identifiers

NCT: NCT05792280 · 2023-EUS-AI-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗