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

Lunit Inc.700 enrolled

Overview

This study aims to evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities

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 Type

OBSERVATIONAL

Enrollment

700

Conditions

Pulmonary Disease

Interventions

Chest X-rayRADIATION

Chest radiographs

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

SMG-SNU Boramae Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

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)

Time frame: through study completion, an average of 6 months

Data from ClinicalTrials.gov

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