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

Breast Cancer Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT03611543
• Study type: Observational
• Source: Hologic, Inc.
• Status: Completed
• Start date: October 20, 2016
• Completion date: June 18, 2018