Artificial Intelligence-aimed Point-of-care Ultrasound Image Interpretation System

September 15, 2025 updated by: National Taiwan University Hospital
This proposal is for an one-year project. In this project, we aim to investigate the feasibility of using AI for sonographic image interpretation. The main project is responsible for coordination between the two sub-projects and the main project, providing image resources, and using U-Net (Convolutional Networks for Biomedical Image Segmentation) and Transfer Learning to build up the models for image recognition and validating the efficacy of the models. The purpose of Subproject 1 is to develop an image recognition system for dynamic images: pericardial effusion. After building up the model, validating the efficacy and future revision will be done. Subproject 2 comes out an image recognition system for static images: hydronephrosis. After building up the model, validating the efficacy and future revision will be done.

Study Overview

Detailed Description

Ultrasound is a non-invasive and non-radiated diagnostic tool in the emergency and critical care settings. In clinical practice, timely interpretation of sonographic images to facilitate decision-making is essential. However, it depends on operators' experience. As usual, it takes time for junior emergency physicians to have good diagnostic accuracy through traditional sonographic education. How to shorten the learning This proposal is for an one-year project. In this project, we aim to investigate the feasibility of using AI for sonographic image interpretation. The main project is responsible for coordination between the two sub-projects and the main project, providing image resources, and using U-Net (Convolutional Networks for Biomedical Image Segmentation) and Transfer Learning to build up the models for image recognition and validating the efficacy of the models. The purpose of Subproject 1 is to develop an image recognition system for dynamic images: pericardial effusion. After building up the model, validating the efficacy and future revision will be done. Subproject 2 comes out an image recognition system for static images: hydronephrosis. After building up the model, validating the efficacy and future revision will be done.

This pioneer study can provide two AI-assisted ultrasound image recognition systems in the real clinical conditions. They can experience of clinical applications and contribute to current medical education. Moreover, it can improve decision-making process and quality of care in the emergency and critical care units. Furthermore, the set-up models can be used in other target ultrasound image recognition in the future.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • None Selected
      • Taipei, None Selected, Taiwan, 100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • patients receiving echocardiography or renal ultrasound

Exclusion Criteria:

  • patients not receiving echocardiography or renal ultrasound

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Artificial intelligence-aimed ultrasound image interpretation
improve the sensitivity and specificity of the AI-aimed ultrasound interpretation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensitivity and specificity of AI interpretation
Time Frame: 6 months
increase the sensitivity and specificity of AI to interpret the ultrasound image
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Wan-Ching Lien, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

May 2, 2021

First Submitted That Met QC Criteria

May 2, 2021

First Posted (Actual)

May 6, 2021

Study Record Updates

Last Update Posted (Estimated)

September 19, 2025

Last Update Submitted That Met QC Criteria

September 15, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 202006124RINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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