NCT03611543

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 443 (actual)
• Sponsor: Hologic, Inc. · Industry
• Sex: Female
• Age: 25 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	Standard of Care Flat Paddle	X-Ray Mammogram Exam. Each screening subject will receive a 4-view 2D plus 3D combination imaging: Left Cranial Caudal (LCC), Left Medial Oblique (LMO), Right Cranial Caudal (RCC), and Right Medial Oblique (RMLO) with the current standard of care (SOC) flat paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the SOC flat paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness.
DEVICE	Investigational Curved Paddle	X-Ray Mammogram Exam. Each screening subject will receive a CC and an MLO in one of her breasts as determined by a randomization scheme with the investigational (INV) curved paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the INV curved paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness.

Timeline

• Start date: 2016-10-20
• Primary completion: 2018-06-18
• Completion: 2018-06-18
• First posted: 2018-08-02
• Last updated: 2025-05-21
• Results posted: 2025-05-21

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study