Breast Cancer Female
Conditions
Keywords
Breast Biopsy, Breast Biopsy Imaging, Stereotactic Imaging
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.
Interventions
DEVICEBrevera 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.
Sponsors
Hologic, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female aged 18 years of age or older * 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 who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy. * Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Total time elapsed between from when the subject enters the procedure room until she has left the procedure room. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Average Number of 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 | The average number of cores obtained for each lesion across all sites. |
| Percentage of Procedures With Overall Positive Opinion 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 | 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). |
Countries
France, Germany, Italy, Netherlands, Spain, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 500 |
| Total | 500 |
Baseline characteristics
| Characteristic | Brevera Breast Biopsy System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 500 Participants | — |
| Age, Continuous | 57.4 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 81 participants | — |
| Region of Enrollment Germany | 28 participants | — |
| Region of Enrollment Italy | 100 participants | — |
| Region of Enrollment Netherlands | 100 participants | — |
| Region of Enrollment Spain | 100 participants | — |
| Region of Enrollment United Kingdom | 91 participants | — |
| Sex: Female, Male Female | 500 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 500 |
| other Total, other adverse events | 11 / 500 |
| serious Total, serious adverse events | 0 / 500 |
Outcome results
Primary
Procedural Time
Total time elapsed between from when the subject enters the procedure room until she has left the procedure room.
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brevera Breast Biopsy System | Procedural Time | 38.44 Minutes | Standard Deviation 14.17 |
Secondary
Average Number of Cores Per Lesion
The average number of cores obtained for each lesion across all sites.
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brevera Breast Biopsy System | Average Number of Cores Per Lesion | 10.58 Cores Per Lesion |
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).
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Brevera Breast Biopsy System | Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient | 76.3 Percentage of procedures |
| Technologists' Feedback | Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient | 66.9 Percentage of procedures |
| Patients' Feedback | Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient | 96.8 Percentage of procedures |
Secondary
Post-biopsy Complication Rates
Adverse event rates.
Time frame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Population: Enrolled subjects
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brevera Breast Biopsy System | Post-biopsy Complication Rates | 11 Participants |