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| Name | Class |
|---|---|
| Elizabeth Wende Breast Care, LLC | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Right Breast Mammogram Measurements and Survey | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bella Blankets protective coverlets | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment as an Aid to Achieve Standards for Mammogram EQUIP Compliance Measurements. | An assessment by the Principal Investigator,based on CIQ results and the FDA CIQ EQUIP standards, determining if Bella Blankets protective coverlets can be used by technologists to aid in achieving EQUIP compliance measurements in a mammogram. | At the completion of 100 participants; approximately 4 months from study initiation |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elizabeth Wende Breast Care, LLC | Rochester | New York | 14620 | United States |
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Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
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