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Patient-Assisted Compression - Impact on Image Quality and Workflow

NCT03196635 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2018-08-31

Study results available
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Summary

This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled \[TC\]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow.

Conditions

Interventions

DEVICE

Patient-Assisted (PA) Breast Compression

The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC \& MLO.

DEVICE

Technologist-Controlled (TC) Breast Compression

TC compression will be conducted per standard of care practices at the site.

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Kathy Schilling · Boca Raton Regional Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-19
Primary Completion
2017-06-29
Completion
2017-06-29
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03196635 on ClinicalTrials.gov