Covid19 Clinical Trial
Official title:
Evaluation of a Chest X-Ray AI Neural Network (RadGen SARS-CoV2 Detection System) for the Detection of RT-PCR Confirmed SARS-Cov2 Covid-19 Pneumonia
Verified date | September 2020 |
Source | Ensemble Group Holdings, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study investigates the diagnostic performance of an AI algorithm in the detection of COVID-19 pneumonia on chest radiographs.
Status | Active, not recruiting |
Enrollment | 4000 |
Est. completion date | December 31, 2020 |
Est. primary completion date | October 30, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 120 Years |
Eligibility |
Inclusion Criteria: - All adult patients >18 years of age - Attended any of the participating institutes between February 1, 2020 until September, 2020 - Underwent both RT-PCR testing and frontal CXR (within 48 hours of PCR testing) for COVID-19 infection - frontal CXR of patients pre-covid pandemic Exclusion Criteria: - Unavailability of patient demographics and clinical data - Inconclusive RT-PCR results - CXR considered to be of non-diagnostic quality by the clinical radiology research team at each site - CXR not in a retrievable or processable format for AI inference |
Country | Name | City | State |
---|---|---|---|
Hong Kong | University of Hong Kong | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
Ensemble Group Holdings, LLC |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic Performance of AI model | Performance (accuracy, sensitivity, specificity, false-positive rate (FPR), false-negative rate (FNR), and Area Under the Curve (AUC)) of the AI model in detection of COVID-19 pneumonia on their baseline CXR using RT-PCR and historical controls as gold standard in a multi-center / multi-national cohort. | 9 months |
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