A Clinical Analysis of Bella Blankets® Protective Coverlets

Beekley Medical100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

100

Conditions

Screening Mammogram

Interventions

Bella Blankets protective coverletsDEVICE

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.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Elizabeth Wende Breast Care, LLC

Rochester, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Through the completion of 100 participants; approximately 4 months

Secondary Outcomes

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.

Time frame: Through the completion of 100 participants; approximately 4 months

Data from ClinicalTrials.gov

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