PMA Required Pivotal Multi-reader Multi-case Reader Study
NCT01952717 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 236
Last updated 2015-03-11
Summary
A pivotal multi-reader multi-case (MRMC) study to compare the diagnostic performance of 3D Koning Breast Computed Tomography (KBCT) to that of 2D Diagnostic Mammography to support the Pre-market Approval (PMA) of KBCT by the US Food and Drug Administration (FDA).
Conditions
- Breast Cancer Diagnosis
Sponsors & Collaborators
-
Koning Corporation
lead INDUSTRY
Eligibility
- Min Age
- 35 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-06-30
- Primary Completion
- 2014-03-31
- Completion
- 2014-03-31
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