A Study to Evaluate Chang Gung Pneumothorax Detection Software

January 9, 2024 updated by: Chang Gung Memorial Hospital

A Study to Evaluate Accuracy and Validity of Chang Gung Pneumothorax Detection Software Compared With Reference by Qualified Physicians

The Chang Gung Pneumothorax Detection Software is a medical software that can automatically detect whether there is a pneumothorax in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pneumothorax Detection Software can correctly identify patients with pneumothorax in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This clinical trial is a retrospective study. DICOM images of de-identified Chest X-Ray were collected from 6 hospitals of Chang Gung Memorial Hospital from January 1, 2006 to December 31, 2020. The test set of 5,347 items was established, and total of 344 cases will be sampled by simple random stratification, including 172 cases with pneumothorax and 172 cases without pneumothorax. The image must be in DICOM format.

Follow-up by three specialist physicians to interpret the presence or absence of pneumothorax, the result will be the standard of this test (Reference). After confirming the correct standard of each Chest X-Ray, the Chest X-Ray will be put into Chang Gung Pneumothorax Detection Software, and analyzed by the primary and secondary outcomes.

Study Type

Observational

Enrollment (Estimated)

344

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 Locations

  • Taiwan
      • Taoyuan City, Taiwan, 333
        • Chang Gung Memorial Hospital

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. According to inclusion and exclusion criteria, Chest X-ray data from the database during 2006.01.01~2020.12.31 was collected.

Description

Inclusion Criteria:

  • The case were over 20 years old and under 100 years old.
  • DICOM format.
  • Brand model of Canon.
  • DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels).
  • poster-anterior view(PA-view) of chest X-ray

Exclusion Criteria:

  • The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms.
  • The chest X-ray that are difficult to interpret due to poor image quality.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Software diagnosis
Software diagnosis with gold standard of 3 doctors' interpretation.
Device: Chang Gung Pneumothorax Detection Software

The Chang Gung Pneumothorax Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pneumothorax. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pneumothorax.

This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity
Time Frame: baseline
The rate of test results that correctly indicate the presence.
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Specificity
Time Frame: baseline
The rate of test results that correctly indicate the absence.
baseline
Area Under the receiver operating characteristic Curve
Time Frame: baseline
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
baseline

Collaborators and Investigators

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

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Chang-Fu Kuo, Associate Professor and Director Division of Rheumatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 13, 2022

Primary Completion (Actual)

December 15, 2023

Study Completion (Estimated)

January 12, 2024

Study Registration Dates

First Submitted

June 6, 2023

First Submitted That Met QC Criteria

June 6, 2023

First Posted (Actual)

June 15, 2023

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202200871B0

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

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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