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

Lunit

Status: Completed

Conditions: Pulmonary Disease

Treatments: Radiation: Chest X-ray

Study type: Observational

Funder types: Industry

Identifiers

NCT05614232

LUN_CXR_CA_221

Details and patient eligibility

About

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

Full 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.

Enrollment: 700 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

700 participants in 2 patient groups

Positive group

Description:

chest radiographs with the specific target radiologic findings (Atelectasis, Calcification, Cardiomegaly, Consolidation, Fibrosis, Mediastinal Widening, Nodule/Mass, Pleural Effusion, Pneumoperitoneum, Pneumothorax)

Treatment:

Radiation: Chest X-ray

Negative group

Description:

chest radiographs with no target radiologic findings

Treatment:

Radiation: Chest X-ray