An observational study in Breast Cancer Female, sponsored by Hologic, Inc.. Completed at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Hologic, Inc. · Observational
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 525 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Female subjects who require a stereotactic breast biopsy procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Breast Biopsy
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).
Device: 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.
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.
Time frame: 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.
Post-biopsy Complication Rates
Adverse event percentage rates.
Time frame: 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
Time frame: 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).
Time frame: 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
| Milestone | Brevera Breast Biopsy System | Standard of Care |
|---|---|---|
| Started | 316 | 209 |
| Completed | 316 | 209 |
| Not completed | 0 | 0 |
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.
| procedure time in minutes | Brevera Breast Biopsy System | Standard of Care |
|---|---|---|
| Difference in Procedural Time in Minutes | 42.15 ± 14.06 | 40.13 ± 12.14 |
Adverse event percentage rates.
| Participants | Brevera Breast Biopsy System | Standard of Care |
|---|---|---|
| Post-biopsy Complication Rates | 9 | 4 |
Number of samples collected per lesion
| samples obtained | Brevera Breast Biopsy System | Standard of Care |
|---|---|---|
| Number of Samples Collected Per Lesion | 6.69 ± 3.39 | 7.25 ± 2.69 |
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).
| percentage of procedures | Radiologist Feedback | Technologist Feedback | Subject Feedback |
|---|---|---|---|
| Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients | 79.8 (8.9 to 91.1) | 72.8 (6.6 to 94.4) | 99.0 (0.3 to 99.7) |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brevera Breast Biopsy System | 0/316 (0%) | 0/316 (0%) | 9/316 (2.8%) |
| Standard of Care | 0/209 (0%) | 0/209 (0%) | 4/209 (1.9%) |
| Event | Brevera Breast Biopsy System | Standard of Care |
|---|---|---|
| Anticipated Adverse EventsInjury, poisoning and procedural complications | 9/316 | 4/209 |
| Age, Customized(years) | Brevera Breast Biopsy System | Standard of Care | Total |
|---|---|---|---|
| Mean | 57.80 ± 11.25 | 58.08 ± 11.93 | 57.91 ± 11.51 |
| Sex: Female, Male(Participants) | Brevera Breast Biopsy System | Standard of Care | Total |
|---|---|---|---|
| Female | 316 | 209 | 525 |
| Male | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Brevera Breast Biopsy System | Standard of Care | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Sep 2017 to primary completion in Mar 2019, 18 months.
Results were first posted in Dec 2024, 5 years 8 months after primary completion.
Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's 18 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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