Screening Mammogram
Conditions
Brief summary
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.
Interventions
DEVICEBella Blankets protective coverlets
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.
Sponsors
Elizabeth Wende Breast Care, LLC
Beekley Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Through the completion of 100 participants; approximately 4 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Survey | Through the completion of 100 participants; approximately 4 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment as an Aid to Achieve Standards for Mammogram EQUIP Compliance Measurements. | At the completion of 100 participants; approximately 4 months from study initiation | 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. |
Countries
United States
Outcome results
None listed