Mediastinal DiseaseNCT06790108
Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial
A study testing Artificial intelligence device in people with Mediastinal Disease, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial 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. A comparison of the image recognition accuracy between the AI system and EUS endoscopists. 2. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Mediastinal Disease
- What is being tested?
- Artificial intelligence device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Xiaoyan Wang, Doctor, +8613974889301, wangxiaoyan@csu.edu.cn
About this study
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:
- A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
- Whether the AI system can improve the quality of mediastinal scans for EUS endoscopists.
Participants will conduct mediastinal EUS with or without the assistance of the AI system.
- Conditions
- Mediastinal Disease
- Being tested
- Artificial intelligence device
- Medical subject headings
- Mediastinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial intelligence deviceDevice
This AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods.
| Study group | Role | What they receive |
|---|---|---|
| AI-assisted group | Experimental | Endoscopists perform scans with the assistance of AI device. Receives: Device: Artificial intelligence device |
| Control group | Placebo comparator | Endoscopists perform scans without the assistance of AI device. Receives: Device: Artificial intelligence device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (3)
The completeness of anatomical structure scanning
It calculated as the number of anatomical structures successfully scanned divided by the total number of structures that should have been scanned.
Measured: 1 year
Procedure time
It defined as the observation time only, excluding the time spent on puncture, elastography, contrast-enhanced ultrasound, or other lesion observation or treatment.
Measured: 1 year
The incidence of adverse events
The incidence of adverse events in both groups during the entire research process.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start15 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal DiseaseStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZhuZhou Central Hospital, The First Affiliated Hospital of University of South China, The First People's Hospital of Chenzhou, the Affiliated Nanhua Hospital, University of South China
- Responsible party
- Sponsor
- Investigators
- Xiaoyan Wang, Doctor, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790108
- Sponsor's protocol ID
- 2023-EUS-AI-002-2
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of an AI-Assisted Mediastinal EUS System for Training Improvement: a Prospective, Multi-Center, Randomized Trial
- ClinicalTrials.gov ID
- NCT06790108
- Acronym / sponsor ID
- 2023-EUS-AI-002-2
- Conditions
- Mediastinal Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Collaborators
- ZhuZhou Central Hospital, The First Affiliated Hospital of University of South China, The First People's Hospital of Chenzhou, the Affiliated Nanhua Hospital, University of South China
- Study start
- 15 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A comparison of the image recognition accuracy between the AI system and EUS endoscopists.
- Whether the AI system can improve the quality of mediastinal scans for EUS endoscopists.
Participants will conduct mediastinal EUS with or without the assistance of the AI system.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-assisted group | Experimental | Device: Artificial intelligence deviceEndoscopists perform scans with the assistance of AI device. |
| Control group | Placebo comparator | Device: Artificial intelligence deviceEndoscopists perform scans without the assistance of AI device. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial intelligence deviceThis AI device can provide prompts for standard sites of pancreatic scans and anatomical structures. It may also suggest the next operation methods. | Device | AI-assisted group, Control group |
Primary outcome
The completeness for standard station scanning
Time frame: 1 year
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.
3 secondary outcomes
The completeness of anatomical structure scanning
Time frame: 1 year
Procedure time
Time frame: 1 year
The incidence of adverse events
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No. Some data underlying this trial cannot be shared publicly due to protection of participant's privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyan Wang, Doctor principal investigator
The Third Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial intelligence device in people with Mediastinal Disease, run by The Third Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyan Wang, Doctor (+8613974889301, wangxiaoyan@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The completeness for standard station scanning (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.