A Clinical Analysis of Bella Blankets® Protective Coverlets

Study Overview
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Brief Summary
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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.

Official Title
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A Clinical Analysis of Bella Blankets® Protective Coverlets Used to Increase the Image Quality of Mammograms, Aid as a Quality Standard for EQUIP Clinical Image Quality (CIQ) Compliance Measurements and Improve Patient Satisfaction.

Conditions
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Screening Mammogram

Intervention / Treatment
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* Device: Bella Blankets protective coverlets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right Breast Mammogram Measurements and Survey<br>A right breast screening mammogram will be performed with Bella Blankets protective coverlets on the imaging receptor plate, then removed from the equipment. The screening mammogram continues with a left breast and second right breast screening mammogram on a bare imaging receptor plate. Clinical image quality measurements for the right breast mammograms will automatically be captured by VolparaEnterprise for a comparative analysis. A patient satisfaction survey will be completed by each participant and the results will be analyzed. | Device: Bella Blankets protective coverlets<br>* Bella Blankets protective coverlets is a Class II 510(k) Cleared (2008) single-use, adhering, non-woven fabric sheet applied to the mammography equipment receptor plate to provide a more comfortable mammogram.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Image Quality (CIQ) Outcomes of a Participant's Right Breast Mammogram Performed with Bella Blankets Protective Coverlets on the Receptor Plate to a Bare Receptor Plate. | Comparison of the Clinical Image Quality (CIQ) analytics, automatically captured by VolparaEnterprise, for the participant's right breast mammogram performed on a receptor plate with Bella Blankets protective coverlets to the same right breast mammogram performed on a bare receptor plate during the same screening mammogram visit. | Through the completion of 100 participants; approximately 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction Survey | A questionnaire completed by the participant after their mammogram and prior to exit. The one-page questionnaire requires the participant answers each question by selecting one Likert Scale option about their experience with the use and without the use of Bella Blankets protective coverlets. | Through the completion of 100 participants; approximately 4 months |