NCT05903287

Validity of Pleural Effusion Detection Software

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 282 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The Chang Gung Pleural Effusion Detection Software is a medical software that can automatically detect whether there is a pleural effusion in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pleural Effusion Detection Software can correctly identify patients with pleural effusion 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.

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, 2018 to December 31, 2020. After confirming that the Chest X-Ray that meet the inclusion and exclusion criteria are correct, 282 samples will be sampled for this test, including 141 images with pleural effusion and 141 images without pleural effusion. The image must be in DICOM format. Then, 3 specialists physicians interpret 282 samples whether there were pleural effusion, and the result was the standard of this study (Reference standard). After determining the reference standard of each Chest X-Ray, the 282 samples were input into the Chang Gung Pleural Effusion Detection Software, and analyzed by the primary and secondary outcomes.

Conditions

• Pleural Effusion

Interventions

Type	Name	Description
DEVICE	Chang Gung Pleural Effusion Detection Software	The Chang Gung Pleural Effusion Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pleural effusion. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pleural effusion. This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old.

Timeline

• Start date: 2023-06-17
• Primary completion: 2023-11-23
• Completion: 2024-08-12
• First posted: 2023-06-15
• Last updated: 2024-01-11

Locations

1 site across 1 country: Taiwan