Brevera™ Breast Biopsy System Data Collection Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-20

Study Completion Date

2018-11-20

Brief Summary

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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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Detailed Description

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Conditions

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Breast Cancer Female

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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. 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.

Brevera Breast Biopsy System

Intervention Type 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.

Interventions

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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. 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No