Case Collection Study for Collecting Images for the Development and Validation of Computer Aided Detection Software
NCT00756834 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 135
Last updated 2020-08-21
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.
Conditions
Interventions
- DEVICE
-
Screening
The MammoDetector™ Pro is a computer-aided software intended to identify and mark regions of interest on standard mammographic views to bring them to the attention of the radiologist after the initial reading has been completed. Thus, the device assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review
Sponsors & Collaborators
-
Siemens Medical Solutions
lead INDUSTRY
Principal Investigators
-
Louise Ebbert · Siemens Medical Solutions
Eligibility
- Min Age
- 40 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2006-11-30
- Primary Completion
- 2020-08-31
- Completion
- 2020-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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