Screening MammogramNCT03622294
A Clinical Analysis of Bella Blankets® Protective Coverlets
A study testing Bella Blankets protective coverlets in people with Screening Mammogram, run by Beekley Medical at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, women only
- Conditions the study is for
- Screening Mammogram
- What is being tested?
- Bella Blankets protective coverlets
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 25 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Elizabeth Wende Breast Care, LLC
Rochester, New York, 14620
About this study
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.
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.
- Conditions
- Screening Mammogram
- Being tested
- Bella Blankets protective coverlets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Bella Blankets protective coverlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through the completion of 100 participants; approximately 4 months
Secondary outcomes (1)
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.
Measured: Through the completion of 100 participants; approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start15 Aug 2018
- Primary completion6 Nov 2018
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening MammogramStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beekley Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Elizabeth Wende Breast Care, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622294
- Sponsor's protocol ID
- 423-P-02
- Status last verified
- Jun 2019
- First submitted
- 17 Jul 2018
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03622294
- Acronym / sponsor ID
- 423-P-02
- Conditions
- Screening Mammogram
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beekley MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Elizabeth Wende Breast Care, LLC
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 6 Nov 2018 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 9 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.
| Arm | Type | Receives |
|---|---|---|
| Right Breast Mammogram Measurements and Survey | Experimental | Device: Bella Blankets protective coverletsA 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bella Blankets protective coverletsBella 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. | Device | Right Breast Mammogram Measurements and Survey |
Primary outcome
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.
1 secondary outcome
Patient Satisfaction Survey
Time frame: Through the completion of 100 participants; approximately 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bella Blankets protective coverlets in people with Screening Mammogram, run by Beekley Medical at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2019.