NCT03456583

Brevera™ Breast Biopsy System Data Collection Study

Completed Results posted Last updated 8 October 2024

What this trial tests

trial testing Brevera Breast Biopsy System in Breast Cancer Female in 500 participants. Completed in 20 November 2018.

Timeline

20 November 2017

Primary endpoint
20 November 2018

20 November 2018

Quick facts

Lead sponsor	Hologic, Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	500
Start date	20 November 2017
Primary completion	20 November 2018
Estimated completion	20 November 2018
Sites	6 locations across France, Italy, Netherlands, United Kingdom, Germany, Spain

Drugs / interventions tested

• Brevera Breast Biopsy System

Conditions studied

• Breast Cancer Female — all drugs for Breast Cancer Female →

Sponsor

Hologic, Inc.

Who can join

18 and older, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Procedural Time Primary · 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.

Group	Value	95% CI
Brevera Breast Biopsy System	38.44	± 14.17

Post-biopsy Complication Rates Secondary · 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.

Group	Value	95% CI
Brevera Breast Biopsy System	11

Average Number of Cores Per Lesion Secondary · 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.

Group	Value	95% CI
Brevera Breast Biopsy System	10.58	2 – 48

Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient Secondary · 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).

Group	Value	95% CI
Radiologists' Feedback	76.3	8.45 – 91.5
Technologists' Feedback	66.9	10.1 – 89.9
Patients' Feedback	96.8	0.6 – 99.4

Adverse events — posted to ClinicalTrials.gov

Time frame: 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.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brevera Breast Biopsy System

Serious: 0/500 (0%)

Deaths: 0/500

Other adverse events (3 terms — click to expand)

Reaction	System	Brevera Breast Biopsy System
Hematoma	Injury, poisoning and procedural complications	—
Excessive Bleeding	Injury, poisoning and procedural complications	—
Dislocation of the marker due to some of the postprocedure haemorrage	Injury, poisoning and procedural complications	—

Data from ClinicalTrials.gov NCT03456583 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.