Brevera Study
Research type
Research Study
Full title
A RETROSPECTIVE/PROSPECTIVE STUDY TO EVALUATE THE PERFORMANCE AND OPERATION OF THE BREVERA™ BREAST BIOPSY SYSTEM
IRAS ID
222758
Contact name
William Teh
Contact email
Sponsor organisation
Hologic, Inc.
Duration of Study in the UK
0 years, 7 months, 1 days
Research summary
The Brevera study is a Retrospective/Prospective Study to Evaluate the Performance and Operation of the Brevera Breast Biopsy System.
The objective of the study is to obtain clinical/operational data and feedback on the 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. The system is designed for biopsy and for radiographic image acquisition and display only.
Up to 500 women with suspicious findings on previous imaging (e.g. mammographic, Magnetic Resonance Imaging or Conventional Diagnostic Ultrasound imaging (screening or Diagnostic)) who are sent for biopsy will be enrolled in up to 10 sites across The Netherlands, Italy, France, Germany, Spain and the United Kingdom.
The duration of the study is expected to take 3 months, including enrollment period. The participation of the subject consists of 1 visit. Once the subject has completed the Brevera procedure, a questionnaire will be given to the subject and after completion her direct participation in the study is concluded.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
17/EM/0073
Date of REC Opinion
3 Oct 2017
REC opinion
Further Information Favourable Opinion