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A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
 
Region Sponsors
Mid-Atlantic
Hologic, Inc.
 
Acronym KP IRB No.
MA-17-176
 
Study Type Phase
Prospective Cohort Study with Direct Patient Contact
 
Study Population Description
Breast cancer;
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Female
 
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.

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Oncology (Adult)
 
KP Clinical Facility
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Ainsley MacLean, MD
Contact Information:
- Leslie Greenberg, BA, MS, RN
-Burke Medical Center


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