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

NCT06790108 | Recruiting DMC

• 1 other identifier: 2023-EUS-AI-002-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
2. 2.Whether the AI system can improve the quality of mediastinal scans for EUS endoscopists.

Conditions

Mediastinal Disease

Outcome Measures

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.

  1 year

Secondary Outcomes (3)

• The completeness of anatomical structure scanning

  1 year

• Procedure time

  1 year

• The incidence of adverse events

  1 year

Study Arms (2)

AI-assisted group

EXPERIMENTAL

Endoscopists perform scans with the assistance of AI device.

Device: Artificial intelligence device

Control group

PLACEBO COMPARATOR

Endoscopists perform scans without the assistance of AI device.

Device: Artificial intelligence device

Interventions

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.

AI-assisted group; Control 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
• 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

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, 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; wangxiaoyan@csu.edu.cn

Study Design

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

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: January 15, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)