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NCT05282056 Clinical Trial

COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics

COVID-19 Clinical Trial

Official title:
COVID-19 Volumetric Quantification on Computer Tomography Using Computer Aided Diagnostics

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05282056
Other study ID # 282/01.02.2022
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 24, 2022
Est. completion date March 15, 2022

Study information
Verified date May 2022
Source XVision
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to asses the influence of computer aided diagnostic to the process of lung affection quantification on computer tomography in COVID-19 confirmed patients.

Description:

The lung involvement of COVID-19 patients has been showed to be correlated to clinical outcomes and became part of the clinical practice. Even though various scores can be used, the affection estimation is usually done on computer tomography, using radiologists's estimation skills which is a highly subjective process. Artificial intelligence is a known objective constant and therefore a potential radiologist complement. This trial aims at studying the effect of using a computer aided diagnostic software integrated in the normal clinical practice of radiologists from Timisoara County Emergency Hospital. It uses the AI-PROBE analysis setup, which turns off the CAD outputs for randomly chosen 50% the cases (control) and then compares the radiological reports for differences between the two arms.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers No
Gender All
Age group 16 Years and older
Eligibility Inclusion Criteria: - RT-PCR confirmed patients of COVID-19 Exclusion Criteria: - 15 or lower

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• CAD analysis
CAD shows the radiologist automatically delineated areas of potential COVID-19 affection, together with an overall lung affection percentage.

Locations
Country Name City State
Romania Pius Brinzeu Timisoara County Emergency Hospital Timisoara Timis

Sponsors (2)
Lead Sponsor Collaborator
Bogdan Bercean Pius Brinzeu Timisoara County Emergency Hospital

Country where clinical trial is conducted

Romania, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean difference of lung affection quantification percentage The objective measurement of lung affection percentage is measured against pixel level labels. A lower difference mean better outcome. At CT acquisition time, up to 2 weeks
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