Fujifilm Feature Comparison Reader Study to Compare Old vs New Processing

NCT03586583 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2023-09-21

Study results available
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Summary

The purpose of the feature comparison study is to evaluate general mammographic features in images of the same breast when reconstructed with modified (ISR and DVIIm) processing as compared to the original processing (FBP with EDR and MFP).

Conditions

Interventions

DEVICE

FBP

Old processing

DEVICE

ISR

New processing

Sponsors & Collaborators

  • International HealthCare, LLC

    collaborator OTHER
  • Fujifilm Medical Systems USA, Inc.

    lead INDUSTRY

Principal Investigators

  • Susan Crennan · Fujifilm Medical Systems USA, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-30
Primary Completion
2018-06-30
Completion
2018-11-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03586583 on ClinicalTrials.gov