A Study to Evaluate Chang Gung Pneumothorax Detection Software

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

344 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-13

Study Completion Date

2024-01-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pneumothorax

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Software diagnosis

Software diagnosis with gold standard of 3 doctors' interpretation.

Chang Gung Pneumothorax Detection Software

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No