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Completed

NCT Number: NCT03456583

Brevera™ Breast Biopsy System Data Collection Study

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.

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Institut régional du Cancer de Montpellier, Montpellier, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brevera Breast Biopsy System

Device

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.

Primary outcomes

  1. Procedural Time

    Time frame: 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.

Secondary outcomes

  1. Post-biopsy Complication Rates

    Time frame: 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.

  2. Average Number of Cores Per Lesion

    Time frame: 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.

  3. Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2018
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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