Clinical Research on a Novel Deep-learning Based System i... | NCT05792280

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

NCT05792280

Sponsor

The Third Xiangya Hospital of Central South University

Status

Recruiting

Last Update Posted

Mar 13, 2025Actual

Enrollment

180Estimated

Phase

Not Applicable

Conditions

Mediastinum Disease

Interventions

AI system

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Mar 30, 2025Estimated

Completion Date

Apr 10, 2025Estimated

First Submitted Date

Mar 17, 2023

First Submission Date that Met QC Criteria

Mar 29, 2023

First Posted Date

Mar 31, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2025

Last Update Posted Date

Mar 13, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
AI system	Device	Patients will undergo EUS examination with the assistance of AI system.	AI-assisted group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Cohen's kappa coefficient	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiaoyan Wang, Doctor	Contact	+8613974889301		wxy20011@163.com
Shiqin Huang, MD	Contact	+8618308312098		sqhuang0213@163.com

Overall Officials

Name	Affiliation	Role
Xiaoyan Wang, Doctor	The Third Xiangya Hospital of Central South University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Third Xiangya Hospital of Central South University	Recruiting	Changsha	Hunan	410013	China

IPD Sharing Statement Module

Plan to Share IPD

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D013896	Thoracic Diseases
D012140	Respiratory Tract Diseases