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OpenTrials
Completed

NCT Number: NCT05614232

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

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

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Key information

Conditions

Pulmonary Disease Lung Diseases Respiratory Tract Diseases

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest X-ray

Radiation

Chest radiographs

Primary outcomes

  1. the effectiveness of the investigational device

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

    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)

Sponsors and collaborators

Lead sponsor

Lunit Inc.

Industry

Registry information

Official study title

Single-Center, Retrospective, Pivotal Study to Evaluate the Effectiveness of Investigational Device (Lunit INSIGHT CXR) in Detection of Abnormal Findings on Chest Radiographs

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Nov 14, 2022
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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