Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

Hologic

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Standard of Care Flat Paddle; Device: Investigational Curved Paddle

Study type: Observational

Funder types: Industry

Identifiers

NCT03611543

16-03

Details and patient eligibility

About

The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.

Full description

The study will be conducted in the United States at up to 5 centers. The study will enroll up to 600 subjects. The number of subjects was chosen to allow evaluation of screening and diagnostic patients with a variety of breast densities (fatty, scattered densities, heterogeneously dense or extremely dense) and women with a range of breasts sizes that fit on the current detector. The evaluation of pain reduction will be the primary endpoint, while examining the potential of increased tissue capture without a compromise in image quality will be assessed as secondary endpoints. The enrollment will be consecutive for subjects who sign informed consent to participate. Women participating in the study will present for a screening or diagnostic imaging exam.

Enrollment: 443 patients

Sex: Female

Ages: 25+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is female of any race and ethnicity
• Screening Subject is at least 40 years old, Diagnostic subjects are at least 25 years old
• Subject will be referred for a screening or a diagnostic work-up with tomosynthesis as part of the exam

Exclusion criteria

• Subjects who are pregnant or who think they may be pregnant
• Subjects lactating or presenting with discharge
• Women too large for the detector
• Subjects who cannot give informed consent

Trial design

443 participants in 2 patient groups

STANDARD OF CARE

Description:

All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the standard of care (SOC) flat paddle. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the SOC paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.

Treatment:

Device: Standard of Care Flat Paddle

INVESTIGATIONAL

Description:

All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the investigational (INV) curved paddle. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the INV paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'.

Treatment:

Device: Investigational Curved Paddle