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

NCT05614232 | Completed

• 1 other identifier: LUN_CXR_CA_221
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Positive group

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

Radiation: Chest X-ray

Negative group

chest radiographs with no target radiologic findings

Radiation: Chest X-ray

Interventions

Chest X-ray RADIATION

Chest radiographs

Negative group; Positive group

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Secondary hospital patient

You may qualify if:

• Chest radiographs of aged 14 years or older
• Conventional PA or AP chest radiographs
• Chest radiographs with confirmed radiology reports

You may not qualify if:

• Chest radiographs taken in postures other than PA and AP
• Chest radiographs from dual-energy radiography
• Invert-grayscale chest radiographs

Sponsors & Collaborators

• Lunit Inc.: lead

Study Sites (1)

SMG-SNU Boramae Medical Center

Seoul, 07061, South Korea

Location

MeSH Terms

Conditions

Lung Diseases

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 14, 2022
• Study Start: February 11, 2020
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)