Trial Outcomes & Findings for Brevera™ Breast Biopsy System Data Collection Study (NCT NCT03456583)
NCT ID: NCT03456583
Last Updated: 2024-10-08
Results Overview
Total time elapsed between from when the subject enters the procedure room until she has left the procedure room.
Recruitment status
COMPLETED
Target enrollment
500 participants
Primary outcome timeframe
Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Results posted on
2024-10-08
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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500
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Overall Study
COMPLETED
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500
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Brevera Breast Biopsy System
n=500 Participants
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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Age, Categorical
<=18 years
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0 Participants
n=500 Participants
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Age, Categorical
Between 18 and 65 years
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500 Participants
n=500 Participants
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Age, Categorical
>=65 years
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0 Participants
n=500 Participants
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Age, Continuous
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57.4 years
n=500 Participants
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Sex: Female, Male
Female
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500 Participants
n=500 Participants
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Sex: Female, Male
Male
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0 Participants
n=500 Participants
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Region of Enrollment
Netherlands
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100 participants
n=500 Participants
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Region of Enrollment
United Kingdom
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91 participants
n=500 Participants
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Region of Enrollment
Italy
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100 participants
n=500 Participants
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Region of Enrollment
France
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81 participants
n=500 Participants
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Region of Enrollment
Germany
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28 participants
n=500 Participants
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Region of Enrollment
Spain
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100 participants
n=500 Participants
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PRIMARY outcome
Timeframe: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure OnlyTotal time elapsed between from when the subject enters the procedure room until she has left the procedure room.
Outcome measures
| Measure |
Brevera Breast Biopsy System
n=500 Participants
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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Technologists' Feedback
Technologist with a positive overall opinion of the Brevera Biopsy System for the proceudres (scored 1-5 on Likert Scale).
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Patients' Feedback
Patient agreed that they were satisfied with the facility and the care that they received during the procedure (scored 1-5 on Likert Scale).
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Procedural Time
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38.44 Minutes
Standard Deviation 14.17
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—
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—
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SECONDARY outcome
Timeframe: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure OnlyPopulation: Enrolled subjects
Adverse event rates.
Outcome measures
| Measure |
Brevera Breast Biopsy System
n=500 Participants
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.
|
Technologists' Feedback
Technologist with a positive overall opinion of the Brevera Biopsy System for the proceudres (scored 1-5 on Likert Scale).
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Patients' Feedback
Patient agreed that they were satisfied with the facility and the care that they received during the procedure (scored 1-5 on Likert Scale).
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Post-biopsy Complication Rates
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11 Participants
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—
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—
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SECONDARY outcome
Timeframe: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure OnlyThe average number of cores obtained for each lesion across all sites.
Outcome measures
| Measure |
Brevera Breast Biopsy System
n=530 lesions
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.
|
Technologists' Feedback
Technologist with a positive overall opinion of the Brevera Biopsy System for the proceudres (scored 1-5 on Likert Scale).
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Patients' Feedback
Patient agreed that they were satisfied with the facility and the care that they received during the procedure (scored 1-5 on Likert Scale).
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|---|---|---|---|
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Average Number of Cores Per Lesion
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10.58 Cores Per Lesion
Interval 2.0 to 48.0
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—
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—
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SECONDARY outcome
Timeframe: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure OnlyThe 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).
Outcome measures
| Measure |
Brevera Breast Biopsy System
n=497 Participants
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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Technologists' Feedback
n=496 Participants
Technologist with a positive overall opinion of the Brevera Biopsy System for the proceudres (scored 1-5 on Likert Scale).
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Patients' Feedback
n=496 Participants
Patient agreed that they were satisfied with the facility and the care that they received during the procedure (scored 1-5 on Likert Scale).
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Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient
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76.3 Percentage of procedures
Interval 8.45 to 91.5
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66.9 Percentage of procedures
Interval 10.1 to 89.9
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96.8 Percentage of procedures
Interval 0.6 to 99.4
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Adverse Events
Brevera Breast Biopsy System
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Brevera Breast Biopsy System
n=500 participants at risk
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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Injury, poisoning and procedural complications
Hematoma
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1.8%
9/500 • 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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Injury, poisoning and procedural complications
Excessive Bleeding
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0.20%
1/500 • 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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Injury, poisoning and procedural complications
Dislocation of the marker due to some of the postprocedure haemorrage
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0.20%
1/500 • 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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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place