Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 25 - Any |
| Updated: | 2/24/2019 |
| Start Date: | October 20, 2016 |
| End Date: | June 18, 2018 |
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.
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.
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.
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.
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
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