A Clinical Analysis of Bella Blankets® Protective Coverlets

Not Applicable

Completed

• Conditions: Screening Mammogram
• Interventions: Device: Bella Blankets protective coverlets

• Registration Number: NCT03622294
• Lead Sponsor: Beekley Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-07-17
• Study First Submitted QC: 2018-08-07
• Study First Posted: 2018-08-09
• Study Start: 2018-08-15
• Primary Completion: 2018-11-06
• Status Verified: 2019-06
• Study Completion: 2019-06-25
• Last Update Submitted: 2019-06-25
• Last Update Posted: 2019-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Right Breast Mammogram Measurements and Survey	Bella Blankets protective coverlets	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Elizabeth Wende Breast Care, LLC; 🇺🇸 Rochester, New York, United States