A Clinical Analysis of Bella Blankets® Protective Coverlets

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.

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 Overview

• Status: Completed
• Conditions: Screening Mammogram
• Intervention / Treatment: Device: Bella Blankets protective coverlets

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Elizabeth Wende Breast Care, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Right Breast Mammogram Measurements and Survey; 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; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Beekley Medical
• Collaborators: Elizabeth Wende Breast Care, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 15, 2018
• Primary Completion (ACTUAL): November 6, 2018
• Study Completion (ACTUAL): June 25, 2019

Study Registration Dates

• First Submitted: July 17, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (ACTUAL): August 9, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 27, 2019
• Last Update Submitted That Met QC Criteria: June 25, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 423-P-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes