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Completed

NCT Number: NCT03300206

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

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

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Key information

Conditions

Breast Cancer Female

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

HonorHealth, Phoenix, Arizona, United States

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

Breast Biopsy

Device

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. Difference in Procedural Time in Minutes

    Time frame: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.

    The primary endpoint of this trial is the measured difference in procedure time between biopsies performed with the Brevera biopsy system and those performed with the standard-of-care biopsy systems at each clinical site. Additionally, feedback from the perspective of the participant radiologists, technologists, and subjects using the systems was reported.

Secondary outcomes

  1. Post-biopsy Complication Rates

    Time frame: The time of consent until the subject procedure was completed, an average of 1 day

    Adverse event percentage rates.

  2. Number of Samples Collected Per Lesion

    Time frame: Samples collected from day of Breast Biopsy Procedure Only

    Number of samples collected per lesion

  3. Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients

    Time frame: Through study completion, enrollment expected to take up to 6-10 months at each participant 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 opinion. 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, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
Dec 4, 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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