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OpenTrials
Completed

NCT Number: NCT03622294

A Clinical Analysis of Bella Blankets® Protective Coverlets

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.

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Key information

Conditions

Screening Mammogram

Age range

40 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Elizabeth Wende Breast Care, LLC

Rochester, New York, 14620, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bella Blankets protective coverlets

Device

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.

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Patient Satisfaction Survey

    Time frame: 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.

Other outcomes

  1. Assessment as an Aid to Achieve Standards for Mammogram EQUIP Compliance Measurements.

    Time frame: At the completion of 100 participants; approximately 4 months from study initiation

    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.

Sponsors and collaborators

Lead sponsor

Beekley Medical

Industry

Collaborators

  • Elizabeth Wende Breast Care, LLC

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 9, 2018
Registry last updated
Jun 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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