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N/A N=886

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03611543 ↗
Enrolled (actual)
886
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Subject Comfort — 2.6; 4.0 score on a scale — p=<0.0001

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Standard of Care Flat Paddle (Device); Investigational Curved Paddle (Device)
Age
Adult, Older Adult · 25+ yrs
Sex
Female
Sponsor
Hologic, Inc.
Primary completion
Jun 2018

Outcome Measures

OutcomeResultp-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 —

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.

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
View full record on ClinicalTrials.gov →

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.

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