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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brevera Breast Biopsy System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Procedural Time | Total time elapsed between from when the subject enters the procedure room until she has left the procedure room. | Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only |
| Measure | Description | Time Frame |
|---|---|---|
| Post-biopsy Complication Rates | Adverse event 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 |
| Average Number of Cores Per Lesion |
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Inclusion Criteria:
Exclusion Criteria:
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Any woman who is scheduled for a stereotactic breast biopsy (for possible breast cancer) who meets the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Brad Keller | Hologic, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut régional du Cancer de Montpellier | Montpellier | France | ||||
| Brustdiagnostik Munchen |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Procedural Time | Total time elapsed between from when the subject enters the procedure room until she has left the procedure room. | Posted | Mean | Standard Deviation | Minutes | Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only |
|
subjects were evaluated for the time the procedure began to the release from the outpatient treatment facility per standard of care for any adverse events that they experienced.
There was no Serious Adverse Event There was no Mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematoma | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Waqas | Hologic | 5088267183 | Muhammad.Waqas@hologic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2017 | Oct 11, 2023 | Prot_SAP_000.pdf |
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The average number of cores obtained for each lesion across all sites.
| Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only |
| Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient | The radiologists, technologists, and patients participating in this study were asked to provide feedback on the Brevera Biopsy System at the completion of each procedure. Their responses (raw scores) were reported and converted to percentage of procedures with overall positive opinions. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion). | Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only |
| Tübingen |
| Germany |
| Radiologia Senologica | Milan | Italy |
| Noordwest Ziekenhuisgroep | Alkmaar | Netherlands |
| Centro de Patalogia de la Mama-Fundacion Tejerina | Madrid | Spain |
| Royal Free Londan NHS Foundation Trust | London | United Kingdom |
| Participants |
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| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Post-biopsy Complication Rates | Adverse event rates. | Enrolled subjects | Posted | Count of Participants | Participants | Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only |
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| Secondary | Average Number of Cores Per Lesion | The average number of cores obtained for each lesion across all sites. | Posted | Mean | Full Range | Cores Per Lesion | Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only | lesions | lesions |
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|
|
| Secondary | Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient | The radiologists, technologists, and patients participating in this study were asked to provide feedback on the Brevera Biopsy System at the completion of each procedure. Their responses (raw scores) were reported and converted to percentage of procedures with overall positive opinions. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion). | Posted | Mean | Full Range | Percentage of procedures | Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only |
|
|
|
| 0 |
| 500 |
| 0 |
| 500 |
| 11 |
| 500 |
| Excessive Bleeding | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dislocation of the marker due to some of the postprocedure haemorrage | Injury, poisoning and procedural complications | Non-systematic Assessment |
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