N/A
Completed N=886
Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
Source: ClinicalTrials.gov NCT03611543 ↗Enrolled (actual)
886
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Subject Comfort — 2.6; 4.0 score on a scale — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subject Comfort |
2.6; 4.0 | <0.0001 sig |
| SECONDARY Breast Tissue Coverage |
69; 162; 157 | — |
| SECONDARY Overall Determination of Image Quality |
27; 330; 63 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03611543). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.