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

NCT ID: NCT05619029

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-02

Study Completion Date

2021-09-15

Brief Summary

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

Detailed Description

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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

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Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Positive

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

X-ray

Intervention Type RADIATION

Chest radiographs

Negative

chest radiographs with no target radiologic findings

X-ray

Intervention Type RADIATION

Chest radiographs

Interventions

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X-ray

Chest radiographs

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lunit Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SMG-SNU Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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LUN_CXR_CA_222

Identifier Type: -

Identifier Source: org_study_id

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