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

NCT05792280 | Recruiting

• 1 other identifier: 2023-EUS-AI-002
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Mediastinum Disease

Keywords

EUS; AI; Quality Control; training

Outcome Measures

Primary Outcomes (2)

• Accuracy

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

  1 year

• The completeness for standard station scanning

  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 Outcomes (5)

• 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

• The incidence of adverse events

  Until the end of the study

Study Arms (2)

AI-assisted group

EXPERIMENTAL

Subjects will undergo EUS examination with the assistance of AI system.

Device: AI system

non-assisted group

NO INTERVENTION

Subjects will undergo EUS examination without the assistance of AI system

Interventions

AI system DEVICE

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

AI-assisted group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Mediastinal Diseases

Condition Hierarchy (Ancestors)

Thoracic Diseases; Respiratory Tract Diseases

Study Officials

• Xiaoyan Wang, Doctor

  The Third Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoyan Wang, Doctor

CONTACT

+8613974889301; wxy20011@163.com

Shiqin Huang, MD

CONTACT

+8618308312098; sqhuang0213@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2023
• First Posted: March 31, 2023
• Study Start: January 1, 2021
• Primary Completion: March 30, 2025
• Study Completion: April 10, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)