NCT05903209

A Study to Evaluate Chang Gung Pneumothorax Detection Software

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 344 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Pneumothorax

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-06-13
• Primary completion: 2023-12-15
• Completion: 2024-01-12
• First posted: 2023-06-15
• Last updated: 2024-01-11

Locations

1 site across 1 country: Taiwan