Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05792475
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-27
First Post:
2023-02-10
Brief Title:
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
Sponsor:
TaiHao Medical Inc
Organization:
TaiHao Medical Inc
Study Overview
Official Title:
Evaluation of TaiHao Breast Ultrasound Diagnosis Software Plan for Partial Modification of Diagnostic Performance
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
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:
A standard of truth SOT is determined based on the interpretation results of the case data by interpretation experts and the SOT is compared with the detection results of this programs function for detecting suspected breast cancer CADe function Estimate the detectability of the CADe function by comparing
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?:
False
Is an FDA AA801 Violation?:
None