Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray
Study Details
Study Description
Brief Summary
This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
In the study, the standalone performance of Lunit INSIGHT CXR was primarily assessed by comparing the analysis results from the investigational device and reference standards in the detection of 10 abnormal radiologic findings - atelectasis, calcification, cardiomegaly, consolidation, fibrosis, mediastinal widening, nodule/mass, pleural effusion, pneumoperitoneum, and pneumothorax.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Positive group chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax) |
Radiation: Chest X-ray
Chest radiographs
|
Negative group chest radiographs with no target radiologic findings |
Radiation: Chest X-ray
Chest radiographs
|
Outcome Measures
Primary Outcome Measures
- the effectiveness of the investigational device [through study completion, an average of 6 months]
Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings (detection of any abnormal findings among ten target radiologic findings)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Chest radiographs of aged 14 years or older
-
Conventional PA or AP chest radiographs
-
Chest radiographs with confirmed radiology reports
Exclusion Criteria:
-
Chest radiographs taken in postures other than PA and AP
-
Chest radiographs from dual-energy radiography
-
Invert-grayscale chest radiographs
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | SMG-SNU Boramae Medical Center | Seoul | Korea, Republic of | 07061 |
Sponsors and Collaborators
- Lunit Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LUN_CXR_CA_221