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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00756834 on ClinicalTrials.gov