Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT03622294
Status:
COMPLETED
Last Update Posted:
2019-06-27
First Post:
2018-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Analysis of Bella Blankets® Protective Coverlets
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Participants will be female, asymptomatic patients randomly scheduled for a screening mammogram.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-25', 'studyFirstSubmitDate': '2018-07-17', 'studyFirstSubmitQcDate': '2018-08-07', 'lastUpdatePostDateStruct': {'date': '2019-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Assessment as an Aid to Achieve Standards for Mammogram EQUIP Compliance Measurements.', 'timeFrame': 'At the completion of 100 participants; approximately 4 months from study initiation', 'description': '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.'}], 'primaryOutcomes': [{'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.", 'timeFrame': 'Through the completion of 100 participants; approximately 4 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Patient Satisfaction Survey', 'timeFrame': 'Through the completion of 100 participants; approximately 4 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Screening Mammogram']}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nIn addition, a patient satisfaction survey will be conducted with participants to determine if the use of Bella Blankets protective coverlets improves patient satisfaction."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is Female of any race and ethnicity\n* Subject is 40-75 years old\n* Subject is scheduled for a screening mammogram\n* Subject is willing and able to understand and read the Informed consent form\n* Subject has been a patient at Elizabeth Wende Breast Care for 2 years or more\n\nExclusion Criteria:\n\n* Subject is Male\n* Subject has been a patient at Elizabeth Wende Breast Care for less than 2 years\n* Subject has had a breast biopsy within the last 2 years\n* Subject has had breast surgery within the last 2 years\n* Subject is scheduled for a Diagnostic mammogram\n* Subject suspects or may be pregnant\n* Subject is currently pregnant or breastfeeding\n* Subject has breast implants'}, 'identificationModule': {'nctId': 'NCT03622294', 'briefTitle': 'A Clinical Analysis of Bella Blankets® Protective Coverlets', 'organization': {'class': 'INDUSTRY', 'fullName': 'Beekley Medical'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '423-P-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Right Breast Mammogram Measurements and Survey', 'description': 'A right breast screening mammogram will be performed with Bella Blankets protective coverlets on the imaging receptor plate, then removed from the equipment.\n\nThe screening mammogram continues with a left breast and second right breast screening mammogram on a bare imaging receptor plate.\n\nClinical image quality measurements for the right breast mammograms will automatically be captured by VolparaEnterprise for a comparative analysis.\n\nA patient satisfaction survey will be completed by each participant and the results will be analyzed.', 'interventionNames': ['Device: Bella Blankets protective coverlets']}], 'interventions': [{'name': 'Bella Blankets protective coverlets', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Right Breast Mammogram Measurements and Survey']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Elizabeth Wende Breast Care, LLC', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beekley Medical', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Elizabeth Wende Breast Care, LLC', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}