A Clinical Analysis of Bella Blankets® Protective Coverlets

Screening Mammogram Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03622294
• Other study ID #: 423-P-02
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: June 25, 2019

Study information

• Verified date: June 2019
• Source: Beekley Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 25, 2019
• Est. primary completion date: November 6, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Screening Mammogram

Intervention

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.

Locations

Country	Name	City	State
United States	Elizabeth Wende Breast Care, LLC	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
Beekley Medical	Elizabeth Wende Breast Care, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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