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A Study to Evaluate Chang Gung Pneumothorax Detection Software

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05903209
Recruitment Status : Enrolling by invitation
First Posted : June 15, 2023
Last Update Posted : January 11, 2024
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Pneumothorax Device: Chang Gung Pneumothorax Detection Software

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 Design
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Study Type : Observational
Estimated Enrollment : 344 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: A Study to Evaluate Accuracy and Validity of Chang Gung Pneumothorax Detection Software Compared With Reference by Qualified Physicians
Actual Study Start Date : June 13, 2022
Actual Primary Completion Date : December 15, 2023
Estimated Study Completion Date : January 12, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Collapsed Lung

Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity [ Time Frame: baseline ]
    The rate of test results that correctly indicate the presence.


Secondary Outcome Measures :
  1. Specificity [ Time Frame: baseline ]
    The rate of test results that correctly indicate the absence.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05903209


Locations
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Taiwan
Chang Gung memorial hospital
Taoyuan City, Taiwan, 333
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Chair: Chang-Fu Kuo Associate Professor and Director Division of Rheumatology
More Information
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Publications:

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT05903209    
Other Study ID Numbers: 202200871B0
First Posted: June 15, 2023    Key Record Dates
Last Update Posted: January 11, 2024
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
artificial intelligence
Additional relevant MeSH terms:
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Pneumothorax
Pleural Diseases
Respiratory Tract Diseases