NCT03456583CompletedNot Applicable
A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hologic, Inc.
- Enrollment
- 500
- Locations
- 6
- Primary Endpoint
- Procedural Time
Study Overview
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 clinical/operational data and feedback on the Brevera Breast Biopsy System.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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
- Post-biopsy Complication Rates(Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only)
- Average Number of Cores Per Lesion(Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only)
- Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient(Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only)
Investigators
Study Sites (6)
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