Pleural Effusion Clinical Trial
Official title:
Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
NCT number | NCT05963945 |
Other study ID # | 00002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 18, 2022 |
Est. completion date | March 21, 2023 |
Verified date | July 2023 |
Source | Carebot s.r.o. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists.
Status | Completed |
Enrollment | 956 |
Est. completion date | March 21, 2023 |
Est. primary completion date | November 17, 2022 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Hospital patients > 18 years who were referred for chest radiography October 18th, 2022, and November 17th, 2022 at the Radiodiagnostic Department of the Havírov Hospital, p.o. Exclusion Criteria: - Patients < 18 years - Chest X-ray images in lateral positions - Duplicated chest X-ray images |
Country | Name | City | State |
---|---|---|---|
Czechia | Nemocnice Havírov, p. o. | Havírov |
Lead Sponsor | Collaborator |
---|---|
Carebot s.r.o. |
Czechia,
KVAK, Daniel, Anna CHROMCOVÁ, Petra OVESNÁ, Jakub DANDÁR, Marek BIROŠ, Robert HRUBÝ, Daniel DUFEK a Marija PAJDAKOVIC. Can Deep Learning Reliably Recognize Abnormality Patterns on Chest X-rays? A Multi-Reader Study Examining One Month of AI Implementation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Performance test | The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists. The performance test includes sensitivity and specificity, positive and negative likelihood ratio, and positive and negative predictive value. The aforementioned parameters are statistically compared using confidence intervals (CI) and p-Values. The comparison procedure consists of two steps: a global hypothesis test is conducted to determine whether there are significant differences between DLAD and radiologists. If the global hypothesis test yields a significant result, individual hypothesis tests are performed. Additionally, multiple comparison methods, such as McNemar with continuity correction for Se and Sp, Holm method for LRs, and weighted generalized score statistics for PVs, are applied to control the overall error rate. All tests are performed as two-tailed tests at the 5% significance level. | March 2023 |
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