Ignite Creation Date:
2024-05-06 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05230563
Status:
UNKNOWN
Last Update Posted:
2022-02-09
First Post:
2022-01-14
Brief Title:
A Clinical Study of LUNG-CT CAD Decision Support
Sponsor:
TaiHao Medical Inc
Organization:
TaiHao Medical Inc
Study Overview
Official Title:
A Clinical Study of LUNG-CT CAD Decision Support
Status:
UNKNOWN
Status Verified Date:
2022-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This product is a computer-aided detection software designed to assist clinicians in detecting lung nodules in chest computer tomography This product receives from PACS radiology information system or directly from computer tomography scanner After receiving the image the product performs image analysis and provides a mark of suspected lung nodules Users can use existing medical image capture and transmission systems or reading software to view these annotations on the workstation
The main purpose of this trial is to verify that when clinicians perform chest CT pulmonary nodule detection compared to only diagnosis based on chest CT images whether the Taihao lung CT decision support system helps to improve the diagnostic efficiency of clinicians
The secondary purpose is to evaluate that when clinicians perform chest CT pulmonary nodule detection compared to only diagnosis based on chest CT images whether the Taihao lung CT decision support system helps to improve the sensitivity specificity and image interpretation time Reading Time of clinicians
The main purpose of this trial is to verify that when clinicians perform chest CT pulmonary nodule detection compared to only diagnosis based on chest CT images whether the Taihao lung CT decision support system helps to improve the diagnostic efficiency of clinicians
The secondary purpose is to evaluate that when clinicians perform chest CT pulmonary nodule detection compared to only diagnosis based on chest CT images whether the Taihao lung CT decision support system helps to improve the sensitivity specificity and image interpretation time Reading Time of clinicians
Detailed Description:
None
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