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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 as compared to the current standard-of-care breast biopsy procedures
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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. |
| |
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Biopsy | Device | 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 |
|---|---|---|
| Difference in Procedural Time in Minutes | The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported. | Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-biopsy Complication Rates | Adverse event percentage rates. | The time of consent until the subject procedure was completed, an average of 1 day |
| Number of Samples Collected Per Lesion | Number of samples collected per lesion |
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Inclusion Criteria:
Exclusion Criteria:
Only females (biologic) will be eligible for participation in the clinical trial.
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Female subjects who require a stereotactic breast biopsy procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HonorHealth | Phoenix | Arizona | 85027 | United States | ||
| Kensington Medical Center - Kaiser Permanente |
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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. 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. |
| FG001 | 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. |
| 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. 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| 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 | Difference in Procedural Time in Minutes | The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported. | This study involved the participation of 525 female patients aged 18 years or older with suspicious findings on mammographic screening or diagnostic exams who were sent for breast biopsy. These subjects were enrolled at seven different clinical sites (75 subjects per site) and then separated to have their biopsy procedure performed using the current standard of care breast biopsy procedure (209) or the Brevera Breast Biopsy system (316). | Posted | Mean | Standard Deviation | procedure time in minutes | Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes. |
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2 hours: per the standard of care protocol, each subject participating in this study was evaluated for any adverse events from the time the biopsy procedure began to the time the subject was released from the outpatient treatment facility.
No serious adverse events were reported in this study.
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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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anticipated Adverse Events | Injury, poisoning and procedural complications | Non-systematic Assessment | Most of the observed anticipated adverse events were related to syncope/fainting/panic attack/excessive bleeding (1 case)/hematoma (1 case). All these events were resolved the same day they started. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hologic Clinical Research Team | Hologic | 508.263.2900 | ClinicalResearch@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 | Jun 23, 2017 | Nov 17, 2022 | Prot_SAP_000.pdf |
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| Samples collected from day of Breast Biopsy Procedure Only |
| Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients | 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 opinion. 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 participant site. Data collected from day of Breast Biopsy Procedure Only |
| Kensington |
| Maryland |
| 29895 |
| United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Elizabeth Wende Breast Center | Rochester | New York | 14620 | United States |
| Magee-Womens Hospital of UPMC | Pittsburgh | Pennsylvania | 15213 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| University of Utah - Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| 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 |
|
| OG000 | 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. |
| OG001 | 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. |
|
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| Secondary | Post-biopsy Complication Rates | Adverse event percentage rates. | Posted | Count of Participants | Participants | The time of consent until the subject procedure was completed, an average of 1 day |
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| Secondary | Number of Samples Collected Per Lesion | Number of samples collected per lesion | Posted | Mean | Standard Deviation | samples obtained | Samples collected from day of Breast Biopsy Procedure Only |
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| Secondary | Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients | 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 opinion. The scale goes from 0% (poor/negative opinion) to 100% (excellent/positive opinion). | Posted | Number | 95% Confidence Interval | percentage of procedures | Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only |
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| 0 |
| 316 |
| 0 |
| 316 |
| 9 |
| 316 |
| EG001 | 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. | 0 | 209 | 0 | 209 | 4 | 209 |
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If a publication by the collaborative participants is not being conceived or submitted within 10 months following the conclusion of enrollment at the last enrolling site, an individual site may petition to publish his or her site data independently of the group. Hologic will advise on the status of publications in process and determine when individual results may be released.