Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
KNUCH CadAI-B-1KCB-1
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multinational Clinical Trial of Real-time Artificial Intelligence System CadAI-B for Breast Ultrasound Prospective Clinical Validation Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The CadAI-B Computer Aided Design Artificial Intelligence-Breast system is a real-time AI diagnostic tool for breast ultrasound It integrates with ultrasound devices to detect suspicious lesions providing size BI-RADS and malignancy probability After installation and user training the system displays real-time breast conditions and automatically analyzes lesions when a freeze frame is set showing results in seconds This study will assess CadAI-B39s accuracy and reliability by comparing its findings with biopsy results
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None