Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
NCT03501693 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300
Last updated 2023-09-21
Summary
The purpose of the pivotal reader study is to assess the comparative accuracy of Fujifilm DBT plus S-View versus FFDM in the detection of breast cancer.
Conditions
Interventions
- DEVICE
-
DBT plus S-View
DBT plus S-View images
- DEVICE
-
FFDM Alone
FFDM alone images
Sponsors & Collaborators
-
Fujifilm Medical Systems USA, Inc.
lead INDUSTRY
Principal Investigators
-
Robert M Uzenoff · Fujifilm Medical Systems USA, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-06
- Primary Completion
- 2018-05-24
- Completion
- 2018-08-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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