Status:
COMPLETED
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
Lead Sponsor:
Hologic, Inc.
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Brief Summary
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 c...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 19 2019
Estimated Enrollment :
525 Patients enrolled
Trial Details
Trial ID
NCT03300206
Start Date
September 13 2017
End Date
March 19 2019
Last Update
December 4 2024
Active Locations (7)
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1
HonorHealth
Phoenix, Arizona, United States, 85027
2
Kensington Medical Center - Kaiser Permanente
Kensington, Maryland, United States, 29895
3
Washington University
St Louis, Missouri, United States, 63110
4
Elizabeth Wende Breast Center
Rochester, New York, United States, 14620