Pulmonary Disease Clinical Trial
Official title:
Single-Center, Retrospective, Pivotal Study to Evaluate the Effectiveness of Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs
Verified date | November 2022 |
Source | Lunit Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities
Status | Completed |
Enrollment | 700 |
Est. completion date | July 1, 2020 |
Est. primary completion date | July 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | SMG-SNU Boramae Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Lunit Inc. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the effectiveness of the investigational device | 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) | through study completion, an average of 6 months |
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