Ignite Creation Date:
2024-05-05 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 9:55 AM
Study NCT ID:
NCT00756834
Status:
TERMINATED
Last Update Posted:
2020-08-21
First Post:
2008-09-18
Brief Title:
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
Sponsor:
Siemens Medical Solutions
Organization:
Siemens Medical Solutions
Study Overview
Official Title:
A Multi-center Controlled Consecutive Collection of Screening or Diagnostic Full Field Digital Mammography Images Acquired on the Mammomat Novation DR System for Development and Validation of Computer Aided Detection CAD Software
Status:
TERMINATED
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No longer pursuing FDA submissionapproval
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study objective is to assess the performance of the MammoDetector Pro to correctly mark biopsy-proven breast cancers imaged on the Siemens Mammomat Novation FFDM system compared to conventional film-screen mammography
Detailed Description:
The study design is a controlled study The study is designed to demonstrate that the performance of the MammoDetector Pro on biopsy-proven malignant cases obtained with the Siemens Mammomat NovationDR FFDM system is not inferior to its performance on biopsy-proven malignant cases obtained with conventional film-screen mammography FSM The overall sensitivity of the MammoDetector Pro with both imaging modalities will be compared Furthermore the study is designed to demonstrate that the false marks noted by the MammoDetector Pro on routine screening Normal cases obtained with the FFDM system is not inferior those marked by the software on routine screening Normal cases obtained with conventional film-screen mammography FSM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None