NCT05903287

Brief Summary

The Chang Gung Pleural Effusion Detection Software is a medical software that can automatically detect whether there is a pleural effusion in Chest X-Ray. The purpose of this study is to verify whether the Chang Gung Pleural Effusion Detection Software can correctly identify patients with pleural effusion in Chest X-Ray. The results of the software analysis will be used for the performance of the software on the primary and secondary outcomes.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
282

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

June 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
Last Updated

January 11, 2024

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 6, 2023

Last Update Submit

January 9, 2024

Conditions

Pleural Effusion

Keywords

artificial intelligence

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    The rate of test results that correctly indicate the presence.

    baseline

Secondary Outcomes (2)

  • Specificity

    baseline

  • Area Under the receiver operating characteristic Curve

    baseline

Study Arms (1)

Software diagnosis

Software diagnosis with gold standard of 3 specialist physicians' interpretation.

Device: Chang Gung Pleural Effusion Detection Software

Interventions

Chang Gung Pleural Effusion Detection SoftwareDEVICE

The Chang Gung Pleural Effusion Detection Software is an independent software as a medical device, which inputs digital Chest X-Ray to automatically detect whether there is a pleural effusion. The inferred results output by this software can assist clinicians or professional medical personnel to identify whether a patient has pleural effusion. This product is only used to analyze the digitized Chest X-Ray DICOM of patients over 20 years old and under 100 years old.

Software diagnosis

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This is a retrospective study, and the data comes from the Chang Gung Medical Research Database(CGRD) which was an database form 6 hospitals of Chang Gung Memorial hospital. According to inclusion and exclusion criteria, Chest X-ray data from the database during 2018.01.01\~2020.12.31 was collected.

You may qualify if:

  • The case were over 20 years old and under 100 years old.
  • DICOM format.
  • Brand model of Canon.
  • DICOM resolution length range (700-3400 pixels), width range (490-3600 pixels).
  • poster-anterior view(PA-view) of chest X-ray

You may not qualify if:

  • The chest X-ray contains items that affect interpretation, such as chest tubes, endotracheal tubes, and heart rhythm regulators, but does not include patches and circuits used in electrocardiograms.
  • The chest X-ray that are difficult to interpret due to poor image quality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung memorial hospital

Taoyuan, 333, Taiwan

Location

Related Publications (4)

  • Ahn JS, Ebrahimian S, McDermott S, Lee S, Naccarato L, Di Capua JF, Wu MY, Zhang EW, Muse V, Miller B, Sabzalipour F, Bizzo BC, Dreyer KJ, Kaviani P, Digumarthy SR, Kalra MK. Association of Artificial Intelligence-Aided Chest Radiograph Interpretation With Reader Performance and Efficiency. JAMA Netw Open. 2022 Aug 1;5(8):e2229289. doi: 10.1001/jamanetworkopen.2022.29289.

    PMID: 36044215BACKGROUND

  • Lachin JM. Properties of simple randomization in clinical trials. Control Clin Trials. 1988 Dec;9(4):312-26. doi: 10.1016/0197-2456(88)90046-3.

    PMID: 3203523BACKGROUND

  • Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.

    PMID: 21772732BACKGROUND

  • Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019 Jun;72(3):221-232. doi: 10.4097/kja.19049. Epub 2019 Apr 1.

    PMID: 30929415BACKGROUND

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Study Officials

  • Chang-Fu Kuo, MD/Ph.D

    Associate Professor and Director Division of Rheumatology

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

June 17, 2023

Primary Completion

November 23, 2023

Study Completion

August 12, 2024

Last Updated

January 11, 2024

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)