CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 525 enrolled
Drug / intervention
Breast Biopsydevice
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/NCT03300206
NCT03300206N/ACompleted

A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

Hologic, Inc.·observational·Posted Oct 3, 2017·Updated Dec 4, 2024

In Brief

An observational study evaluating Breast Biopsy for Breast Cancer Female. Completed, enrolled 525 participants across 7 sites.

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 as compared to the current standard-of-care breast biopsy procedures

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 3, 2017
Enrollment StartSep 13, 2017
Primary CompletionMar 19, 2019
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.7 years ago

Interventions

Breast Biopsydevice

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.