Status:
COMPLETED
Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow
Lead Sponsor:
GE Healthcare
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
NA
Brief Summary
Patient-assisted compression (PAC) allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful r...
Detailed Description
The study population will consist of adult asymptomatic women presenting for screening 2D mammography. One breast of each subject will be identified as the "breast of interest," which will undergo stu...
Eligibility Criteria
Inclusion
- Are women aged 40 years or older;
- Are asymptomatic and scheduled for 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
- Are women aged 40 years or older;
- Are asymptomatic and scheduled for 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.
Key Trial Info
Start Date :
January 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2018
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT03456427
Start Date
January 4 2018
End Date
January 9 2018
Last Update
April 5 2019
Active Locations (1)
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1
Boca Raton Regional Hospital
Boca Raton, Florida, United States, 33486