Lung Cancer Clinical Trial
Official title:
Chest X-Ray Abnormality Detection Using Artificial Intelligence: Retrospective Study of Carebot AI CXR Performance in Preclinical Practice
NCT number | NCT05594485 |
Other study ID # | 00001 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 15, 2022 |
Est. completion date | October 20, 2022 |
Verified date | July 2023 |
Source | Carebot s.r.o. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this study is to describe the design, methodology and evaluation of the preclinical test of Carebot AI CXR software, and to provide evidence that the investigated medical device meets user requirements in accordance with its intended use. Carebot AI CXR is defined as a recommendation system (classification "prediction") based on computer-aided detection. The software can be used in a preclinical deployment at a selected site before interpretation (prioritization, display of all results and heatmaps) or after interpretation (verification of findings) of CXR images, and in accordance with the manufacturer's recommendations. Given this, a retrospective study is performed to test the clinical effectiveness on existing CXRs.
Status | Completed |
Enrollment | 127 |
Est. completion date | October 20, 2022 |
Est. primary completion date | August 17, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Hospital patients who were referred for chest radiography between August 15 and 17, 2022. Exclusion Criteria: - Pediatric CXR images (under 18 years of age) - Scans with technical problems (poor image quality, rotation) - Images in lateral projection |
Country | Name | City | State |
---|---|---|---|
Czechia | Nemocnice Havírov, p. o. | Havírov |
Lead Sponsor | Collaborator |
---|---|
Carebot s.r.o. |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Primary objective | Comparison of the accuracy of radiologist and Carebot AI CXR image assessment. | 20-10-2022 | |
Secondary | Secondary objective | Comparison of the accuracy of radiologis with different experience vs. Carebot AI CXR. Weakness assessment of Carebot AI CXR. | 20-10-2022 |
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