A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
NCT ID: NCT03300206
Last Updated: 2024-12-04
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
525 participants
OBSERVATIONAL
2017-09-13
2019-03-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Brevera Breast Biopsy System
The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging.
Breast Biopsy
A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.
Standard of Care
Each of the participating sites will currently be using a vacuum assisted breast biopsy system along with a specimen radiography system (or other specimen imaging system).
Breast Biopsy
A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.
Interventions
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Breast Biopsy
A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.
Eligibility Criteria
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Inclusion Criteria
* Subject has at least one breast imaging finding requiring biopsy for which images are available
* Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her
Exclusion Criteria
* Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.
18 Years
FEMALE
No
Sponsors
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Hologic, Inc.
INDUSTRY
Responsible Party
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Locations
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HonorHealth
Phoenix, Arizona, United States
Kensington Medical Center - Kaiser Permanente
Kensington, Maryland, United States
Washington University
St Louis, Missouri, United States
Elizabeth Wende Breast Center
Rochester, New York, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center
Houston, Texas, United States
University of Utah - Huntsman Cancer Hospital
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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16-05B
Identifier Type: -
Identifier Source: org_study_id