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A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

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Hologic

Status

Completed

Conditions

Breast Cancer Female

Treatments

Device: Breast Biopsy

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

525 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female aged 18 years of age or older
  • Subject has at least one breast imaging finding requiring biopsy for which images are available
  • Subject is able to understand, read and sign the trial specific informed consent form after the nature of the trial has been fully explained to her

Exclusion criteria

  • Patients who, based on the physician's judgment, may be at increased risk or develop complications associated with core removal or biopsy.
  • Patients receiving anticoagulant therapy or may have bleeding disorders which may put the patient at increased risk of procedural complications based upon physicians judgment.

Trial design

525 participants in 2 patient groups

Brevera Breast Biopsy System
Description:
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.
Treatment:
Device: Breast Biopsy
Standard of Care
Description:
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).
Treatment:
Device: Breast Biopsy

Trial documents
1

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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