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A Multi-Reader Multi-Case Pivotal Trial

NCT02692209 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 298

Last updated 2020-07-07

Study results available
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Summary

The purpose of this pivotal reader study is to assess the comparative accuracy of Fujifilm FFDM plus DBT versus FFDM alone in the detection of breast cancer.

Conditions

Interventions

DEVICE

FFDM Plus DBT

FFDM + DBT Images FujiFilm Aspire Cristalle System

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
2015-12-31
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT02692209 on ClinicalTrials.gov