Clinical trial NCT03300206: A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
Official title: A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Female
Keywords: Breast Biopsy
Breast Biopsy Imaging
Stereotactic Biopsy
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-03
Enrollment: 525
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects who require a stereotactic breast biopsy procedure.

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 as compared to the current standard-of-care breast biopsy procedures


Eligibility criteria: 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.

Primary outcomes:
measure: Difference in Procedural Time in Minutes
timeFrame: Average Time- Procedure (1 Lesion per subject): Total Time elapsed from when the subject enters the procedure room until they have left the procedure room, an average of 43 minutes.
Secondary outcomes:
measure: Post-biopsy Complication Rates
timeFrame: The time of consent until the subject procedure was completed, an average of 1 day
measure: Number of Samples Collected Per Lesion
timeFrame: Samples collected from day of Breast Biopsy Procedure Only
measure: Percentage of Procedures With Overall Positive Opinion From Radiologists, Technologists and Patients
timeFrame: Through study completion, enrollment expected to take up to 6-10 months at each participant site. Data collected from day of Breast Biopsy Procedure Only
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: HonorHealth
state: Arizona
city: Kensington
country: United States
facility: Kensington Medical Center - Kaiser Permanente
state: Maryland
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Rochester
country: United States
facility: Elizabeth Wende Breast Center
state: New York
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah - Huntsman Cancer Hospital
state: Utah
Study officials:
References: