NCT05619029

Study to Evaluate the Effectiveness of the Device in Detection of Abnormal Findings on X-ray

Retrospective, Observer-blinded, Pivotal Study to Evaluate the Effectiveness of the Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,111 (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. In addition, to investigate the effect of Lunit INSIGHT CXR assistance on the interpreting physician's interpreting performance, a multi-reader, multi-case (MRMC) study was conducted.

Conditions

• Pulmonary Disease

Interventions

Type	Name	Description
RADIATION	X-ray	Chest radiographs

Timeline

• Start date: 2021-06-02
• Primary completion: 2021-09-15
• Completion: 2021-09-15
• First posted: 2022-11-16
• Last updated: 2022-11-16

Locations

1 site across 1 country: South Korea