Brevera™ Breast Biopsy System Data Collection Study
Study Details
Study Description
Brief Summary
The Brevera Breast Biopsy System integrates tissue acquisition, real time imaging, and post biopsy handling all during the same procedure. This post-market clinical trial will be performed to obtain clinical/operational data and feedback on the Brevera Breast Biopsy System.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. 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. |
Device: 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. 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.
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Outcome Measures
Primary Outcome Measures
- Procedural Time [Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only]
The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system with real time imaging and biopsies performed using the standard-of-care biopsy system at each clinical site.
Secondary Outcome Measures
- Post-biopsy complication rates [Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only]
Adverse event rates.
- Total tissue acquisition by number of cores and sample mass [Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only]
Tissue weight and number of cores collected
- Feedback from Radiologist, Technologist and Patient [Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only]
Questionnaire Feedback using a Likert Scale (Pre-coded responses with the neutral point being neither agree nor disagree). The total averages will be compiled from the survey responses for marketing claims purposes.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Female aged 18 years of age or older
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Subject has at least one breast imaging finding requiring biopsy for which images are available
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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:
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Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy.
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Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institut régional du Cancer de Montpellier | Montpellier | France | ||
| 2 | Brustdiagnostik Munchen | Tübingen | Germany | ||
| 3 | Radiologia Senologica | Milan | Italy | ||
| 4 | Noordwest Ziekenhuisgroep | Alkmaar | Netherlands | ||
| 5 | Centro de Patalogia de la Mama-Fundacion Tejerina | Madrid | Spain | ||
| 6 | Royal Free Londan NHS Foundation Trust | London | United Kingdom |
Sponsors and Collaborators
- Hologic, Inc.
Investigators
- Study Director: Brad Keller, Hologic, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16-05A