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Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer

NCT03491917 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2020-06-18

Study results available
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Summary

The purpose of this pilot is to provide credible performance estimate information in order to conduct a subsequent pivotal reader study.

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

  • Laurie L. Fajardo, M.D. · independent contractor

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2017-12-31
Completion
2018-02-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03491917 on ClinicalTrials.gov