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NCT05614232 Clinical Trial

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

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05614232
Other study ID # LUN_CXR_CA_221
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 11, 2020
Est. completion date July 1, 2020

Study information
Verified date November 2022
Source Lunit Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• Chest X-ray
Chest radiographs

Locations
Country Name City State
Korea, Republic of SMG-SNU Boramae Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Lunit Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
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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