Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05963945
Status:
COMPLETED
Last Update Posted:
2023-07-27
First Post:
2023-07-12
Brief Title:
Multi-Reader Retrospective Study Examining Carebot AI CXR 2021-v201 Implementation in Everyday Radiology Clinical Practice
Sponsor:
Carebot sro
Organization:
Carebot sro
Study Overview
Official Title:
Multi-Reader Retrospective Study Examining Carebot AI CXR 2021-v201 Implementation in Everyday Radiology Clinical Practice
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate the performance parameters of the proposed DLAD Carebot AI CXR in comparison to individual radiologists
Detailed Description:
In the period between October 18th 2022 and November 17th 2022 anonymized chest X-ray images of patients were collected at the Radiodiagnostic Department of the Havířov Hospital po The collection process involved utilizing the CloudPACS imaging and archiving system provided by OR-CZ spol s ro
The collected X-ray images were subjected to the proposed DLAD Carebot AI CXR for analysis Subsequently the DLADs performance was compared with the standard clinical practice where radiologists assessed the CXR images in the simulated hospital setting with access to standard viewing tools eg pan zoom WWWL and were given an unlimited amount of time to complete the review Each radiologist determined the presence or absence of 7 indicated radiological findings including atelectasis ATE consolidation CON pleural effusion EFF pulmonary lesion LES subcutaneous emphysema SCE cardiomegaly CMG and pneumothorax PNO
The collected X-ray images were subjected to the proposed DLAD Carebot AI CXR for analysis Subsequently the DLADs performance was compared with the standard clinical practice where radiologists assessed the CXR images in the simulated hospital setting with access to standard viewing tools eg pan zoom WWWL and were given an unlimited amount of time to complete the review Each radiologist determined the presence or absence of 7 indicated radiological findings including atelectasis ATE consolidation CON pleural effusion EFF pulmonary lesion LES subcutaneous emphysema SCE cardiomegaly CMG and pneumothorax PNO
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None