NCT03622294

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 6, 2018

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

3 months

First QC Date

July 17, 2018

Last Update Submit

June 25, 2019

Conditions

Screening Mammogram

Outcome Measures

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.

    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 Outcomes (1)

  • Patient Satisfaction Survey

    Through the completion of 100 participants; approximately 4 months

Other Outcomes (1)

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

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

Study Arms (1)

Right Breast Mammogram Measurements and Survey

EXPERIMENTAL

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

Interventions

Bella Blankets protective coverletsDEVICE

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.

Right Breast Mammogram Measurements and Survey

Eligibility Criteria

Age40 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elizabeth Wende Breast Care, LLC

Rochester, New York, 14620, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2018

First Posted

August 9, 2018

Study Start

August 15, 2018

Primary Completion

November 6, 2018

Study Completion

June 25, 2019

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

US(1)