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Patient-Assisted Compression - Impact on Image Quality and Workflow | Clinical Trials | Clareo Health

COMPLETEDNA

Patient-Assisted Compression - Impact on Image Quality and Workflow

NCT03196635•GE Healthcare

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.

Detailed Description

Patient-assisted (PA) compression allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. GE Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and PA compression modes. This study is being conducted to compare the image quality of breast images obtained using TC compression and PA compression, and to evaluate the impact of PA compression on clinical workflow. The study population will consist of adult asymptomatic women presenting for screening 2D mammography.

Eligibility

Age

40 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Are women aged 40 years or older;
•Are asymptomatic and scheduled for FFDM screening mammography;
•Have left and right breasts;
•Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
•Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
•Are able and willing to comply with study procedures; and
•Are able and willing to provide written informed consent to participate.

Exclusion Criteria

•Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;
•Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (≤ 5 years) of the study exam date;
•Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;
•Are currently lactating; or
•Have breast implants.

Locations (1)

Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute

Boca Raton, Florida, United States

Key Dates

Start Date

June 19, 2017

Primary Completion Date

June 29, 2017

Completion Date

June 29, 2017

Last Updated

August 31, 2018

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

Patient-Assisted (PA) Breast Compression

DEVICE

Technologist-Controlled (TC) Breast Compression

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 31, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Patient-Assisted Compression - Impact on Image Quality and Workflow

Inclusion Criteria

Exclusion Criteria

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