NCT03196635

Patient-Assisted Compression - Impact on Image Quality and Workflow

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-06-19
• Primary completion: 2017-06-29
• Completion: 2017-06-29
• First posted: 2017-06-23
• Last updated: 2018-08-31
• Results posted: 2018-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study