Trial Outcomes & Findings for A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System (NCT NCT03300206)

NCT ID: NCT03300206

Last Updated: 2024-12-04

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 525 participants
• Primary outcome timeframe: 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.
• Results posted on: 2024-12-04

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. 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.	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.
Overall Study STARTED	316	209
Overall Study COMPLETED	316	209
Overall Study NOT COMPLETED	0	0

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=316 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. 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.	Standard of Care n=209 Participants 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.	Total n=525 Participants Total of all reporting groups
Age, Customized	57.80 years STANDARD_DEVIATION 11.25 • n=316 Participants	58.08 years STANDARD_DEVIATION 11.93 • n=209 Participants	57.91 years STANDARD_DEVIATION 11.51 • n=525 Participants
Sex: Female, Male Female	316 Participants n=316 Participants	209 Participants n=209 Participants	525 Participants n=525 Participants
Sex: Female, Male Male	0 Participants n=316 Participants	0 Participants n=209 Participants	0 Participants n=525 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Population: 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).

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.

Outcome measures

Measure	Standard of Care n=209 Participants 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.	Brevera Breast Biopsy System n=316 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. 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.	Subject Feedback Subjects agreed that they were satisfied with the facility and the care that they received during the procedure (scored 3, 4 or 5 on Likert Scale).
Difference in Procedural Time in Minutes	40.13 procedure time in minutes Standard Deviation 12.14	42.15 procedure time in minutes Standard Deviation 14.06	—

SECONDARY outcome

Timeframe: The time of consent until the subject procedure was completed, an average of 1 day

Adverse event percentage rates.

Outcome measures

Measure	Standard of Care n=209 Participants 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.	Brevera Breast Biopsy System n=316 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. 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.	Subject Feedback Subjects agreed that they were satisfied with the facility and the care that they received during the procedure (scored 3, 4 or 5 on Likert Scale).
Post-biopsy Complication Rates	4 Participants	9 Participants	—

SECONDARY outcome

Timeframe: Samples collected from day of Breast Biopsy Procedure Only

Number of samples collected per lesion

Outcome measures

Measure	Standard of Care n=159 Participants 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.	Brevera Breast Biopsy System n=265 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. 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.	Subject Feedback Subjects agreed that they were satisfied with the facility and the care that they received during the procedure (scored 3, 4 or 5 on Likert Scale).
Number of Samples Collected Per Lesion	7.25 samples obtained Standard Deviation 2.69	6.69 samples obtained Standard Deviation 3.39	—

SECONDARY outcome

Timeframe: 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

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).

Outcome measures

Measure	Standard of Care n=301 Participants 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.	Brevera Breast Biopsy System n=301 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. 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.	Subject Feedback n=296 Participants Subjects agreed that they were satisfied with the facility and the care that they received during the procedure (scored 3, 4 or 5 on Likert Scale).
Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients	72.8 percentage of procedures Interval 6.6 to 94.4	79.8 percentage of procedures Interval 8.9 to 91.1	99.0 percentage of procedures Interval 0.3 to 99.7

Adverse Events

Brevera Breast Biopsy System

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Standard of Care

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Brevera Breast Biopsy System n=316 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. 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.	Standard of Care n=209 participants at risk 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.
Injury, poisoning and procedural complications Anticipated Adverse Events	2.8% 9/316 • Number of events 9 • 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.	1.9% 4/209 • Number of events 4 • 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.

Additional Information

Hologic Clinical Research Team

Hologic

Phone: 508.263.2900

Email: ClinicalResearch@Hologic.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER