CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 500 enrolled
Drug / intervention
Brevera Breast Biopsy Systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03456583
NCT03456583N/ACompleted

A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System

Hologic, Inc.·observational·Posted Mar 7, 2018·Updated Oct 8, 2024

In Brief

An observational study evaluating Brevera Breast Biopsy System for Breast Cancer Female. Completed, enrolled 500 participants across 6 sites in 6 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance, Germany, Italy, Netherlands, Spain, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartNov 20, 2017
Primary CompletionNov 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 8.3 years ago

Interventions

Brevera Breast Biopsy Systemdevice

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.