An observational study in Pleural Effusion, sponsored by Chang Gung Memorial Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-01-11.
Sponsored by Chang Gung Memorial Hospital · Observational
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.
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.
241 studies on the registry are indexed under Pleural Effusion; 50 are open to participants now.
This study's planned enrollment of 282 is above the median of 140 across 93 observational studies indexed under Pleural Effusion.
Browse Pleural Effusion studies →Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.
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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 2018.01.01\~2020.12.31 was collected.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Software diagnosis with gold standard of 3 specialist physicians' interpretation.
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.
Sensitivity
The rate of test results that correctly indicate the presence.
Time frame: baseline
Specificity
The rate of test results that correctly indicate the absence.
Time frame: baseline
Area Under the receiver operating characteristic Curve
A graphical plot that illustrates the diagnostic ability of a binary classifier system as its discrimination threshold is varied.
Time frame: baseline
Plan to share: No
Ran from Jun 2023 to primary completion in Nov 2023, 5 months.
How these figures are worked out, and which studies are left out of them.
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No contact was published for this record. The registry link below has the sponsor’s details.
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