A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
Completed
Conditions studied: Breast Cancer Female
In brief
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
Key facts
- Study ID
- NCT03300206
- Run by
- Hologic, Inc.
- People needed
- 525
- Starts
- 2017-09-13
- Expected to finish
- 2019-03-19
- Last updated by the study team
- 2024-12-04
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- HonorHealth — Phoenix, Arizona, United States
- Kensington Medical Center - Kaiser Permanente — Kensington, Maryland, United States
- Washington University — St Louis, Missouri, United States
- Elizabeth Wende Breast Center — Rochester, New York, United States
- Magee-Womens Hospital of UPMC — Pittsburgh, Pennsylvania, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- University of Utah - Huntsman Cancer Hospital — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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