Trials / Completed
CompletedNCT05614232
Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on Chest X-ray
Single-Center, Retrospective, Pivotal Study to Evaluate the Effectiveness of Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 700 (actual)
- Sponsor
- Lunit Inc. · Industry
- Sex
- All
- Age
- 14 Years
- Healthy volunteers
- Accepted
Summary
This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Chest X-ray | Chest radiographs |
Timeline
- Start date
- 2020-02-11
- Primary completion
- 2020-07-01
- Completion
- 2020-07-01
- First posted
- 2022-11-14
- Last updated
- 2022-11-14
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05614232. Inclusion in this directory is not an endorsement.