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

Sponsor
Lunit Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05614232
Collaborator
(none)
700
1
4.6
151.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Radiation: Chest X-ray

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
700 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Feb 11, 2020
Actual Primary Completion Date :
Jul 1, 2020
Actual Study Completion Date :
Jul 1, 2020

Arms and Interventions

Arm Intervention/Treatment
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
Chest radiographs

Negative group

chest radiographs with no target radiologic findings

Radiation: Chest X-ray
Chest radiographs

Outcome Measures

Primary Outcome Measures

  1. the effectiveness of the investigational device [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 SMG-SNU Boramae Medical Center Seoul Korea, Republic of 07061

Sponsors and Collaborators

  • Lunit Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lunit Inc.
ClinicalTrials.gov Identifier:
NCT05614232
Other Study ID Numbers:
  • LUN_CXR_CA_221
First Posted:
Nov 14, 2022
Last Update Posted:
Nov 14, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 14, 2022