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Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

NCT00999596 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 107

Last updated 2012-12-04

Study results available
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Summary

The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography.

Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.

Conditions

Sponsors & Collaborators

  • Philips Healthcare

    lead INDUSTRY

Principal Investigators

  • Linda Jalbert · Philips Healthcare

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2011-01-31
Completion
2011-09-30

Countries

  • United States
  • Germany

Study Locations

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Entities

Diseases

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 NCT00999596 on ClinicalTrials.gov