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NCT05619029 Clinical Trial

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

Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05619029
Other study ID # LUN_CXR_CA_222
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2, 2021
Est. completion date September 15, 2021

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. 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.

Recruitment information / eligibility
Status Completed
Enrollment 1111
Est. completion date September 15, 2021
Est. primary completion date September 15, 2021
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 e.g.) decubitus, oblique, lordotic, or lateral view - Invert-grayscale chest radiographs - Image quality not suitable for interpretation due to incorrect patient positioning, inadequate image collimation, severely damaged lung presence of external materials such as jewelry

Study Design

Related Conditions & MeSH terms

Intervention

Radiation:
• 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 Area Under the Receiver Operating Characteristic Curve (ROC AUC) of the investigational device in detection of overall target radiologic findings To evaluate the effectiveness of the investigational device (Lunit INSIGHT CXR) in the detection of chest abnormalities, 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) will be measured Through study completion, an average of 6 months
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