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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

443 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-20

Study Completion Date

2018-06-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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STANDARD OF CARE

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'.

Standard of Care Flat Paddle

Intervention Type DEVICE

X-Ray Mammogram Exam.

Each screening subject will receive a 4-view 2D plus 3D combination imaging: Left Cranial Caudal (LCC), Left Medial Oblique (LMO), Right Cranial Caudal (RCC), and Right Medial Oblique (RMLO) with the current standard of care (SOC) flat paddle.

Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the SOC flat paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered.

The amount of compression applied in all mammograms will be to achieve tautness.

INVESTIGATIONAL

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'.

Investigational Curved Paddle

Intervention Type DEVICE

X-Ray Mammogram Exam.

Each screening subject will receive a CC and an MLO in one of her breasts as determined by a randomization scheme with the investigational (INV) curved paddle.

Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the INV curved paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered.

The amount of compression applied in all mammograms will be to achieve tautness.

Interventions

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Standard of Care Flat Paddle

X-Ray Mammogram Exam.

Each screening subject will receive a 4-view 2D plus 3D combination imaging: Left Cranial Caudal (LCC), Left Medial Oblique (LMO), Right Cranial Caudal (RCC), and Right Medial Oblique (RMLO) with the current standard of care (SOC) flat paddle.

Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the SOC flat paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered.

The amount of compression applied in all mammograms will be to achieve tautness.

Intervention Type DEVICE

Investigational Curved Paddle

X-Ray Mammogram Exam.

Each screening subject will receive a CC and an MLO in one of her breasts as determined by a randomization scheme with the investigational (INV) curved paddle.

Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the INV curved paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered.

The amount of compression applied in all mammograms will be to achieve tautness.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes