A Clinical Analysis of Bella Blankets® Protective Coverlets

Beekley Medical

Status: Completed

Conditions: Screening Mammogram

Treatments: Device: Bella Blankets protective coverlets

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03622294

423-P-02

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

Right Breast Mammogram Measurements and Survey

Experimental group

Description:

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.

Treatment:

Device: Bella Blankets protective coverlets