A Clinical Analysis of Bella Blankets® Protective Coverlets

Completed · Not applicable

Conditions studied: Screening Mammogram

In brief

This study will collect and compare clinical image quality measurements of randomly scheduled, asymptomatic, screening mammography patients, right breast mammogram performed with and without the use of Bella Blankets protective coverlets on the receptor plate. The measurements will determine if the use of Bella Blankets protective coverlets increases the mammogram's clinical image quality and if Bella Blankets protective coverlets can be used as an aid for EQUIP compliance. In addition, a patient satisfaction survey will be conducted with participants to determine if the use of Bella Blankets protective coverlets improves patient satisfaction.

Key facts

Study ID: NCT03622294
Run by: Beekley Medical
People needed: 100
Starts: 2018-08-15
Expected to finish: 2019-06-25
Last updated by the study team: 2019-06-27

Who can join

Age: 40 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Subject is Female of any race and ethnicity
Subject is 40-75 years old
Subject is scheduled for a screening mammogram
Subject is willing and able to understand and read the Informed consent form
Subject has been a patient at Elizabeth Wende Breast Care for 2 years or more

You may not qualify if…

Subject is Male
Subject has been a patient at Elizabeth Wende Breast Care for less than 2 years
Subject has had a breast biopsy within the last 2 years
Subject has had breast surgery within the last 2 years
Subject is scheduled for a Diagnostic mammogram
Subject suspects or may be pregnant
Subject is currently pregnant or breastfeeding
Subject has breast implants

Where it is running

Elizabeth Wende Breast Care, LLC — Rochester, New York, United States

Full record on ClinicalTrials.gov

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