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

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT03611543

Run by

Hologic, Inc.

People needed

443

Starts

2016-10-20

Expected to finish

2018-06-18

Last updated by the study team

2025-05-21

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Stamford Hospital — Stamford, Connecticut, United States
• Elizabeth Wende Breast Clinic — Rochester, New York, United States
• Solis Mammagroaphy — Addison, Texas, United States
• TOPS Comprehensive Breast Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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