Ignite Creation Date:
2025-12-25 @ 2:31 AM
Ignite Modification Date:
2025-12-30 @ 8:37 PM
Study NCT ID:
NCT00756834
Status:
TERMINATED
Last Update Posted:
2020-08-21
First Post:
2008-09-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
Sponsor:
Siemens Medical Solutions
Organization:
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 submission/approval.
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:
False
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?: