Clinical trial NCT03456583: Brevera™ Breast Biopsy System Data Collection Study
Official title: A Prospective Study 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 Imaging
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any woman who is scheduled for a stereotactic breast biopsy (for possible breast cancer) who meets the inclusion/exclusion criteria.

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.


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: Procedural Time
timeFrame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Secondary outcomes:
measure: Post-biopsy Complication Rates
timeFrame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
measure: Average Number of Cores Per Lesion
timeFrame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
measure: Percentage of Procedures With Overall Positive Opinion From Radiologist, Technologist, and Patient
timeFrame: Through study completion, enrollment expected to take up to 6-10 months at each site - Data collected from day of Breast Biopsy Procedure Only
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Institut régional du Cancer de Montpellier
city: Tübingen
country: Germany
facility: Brustdiagnostik Munchen
city: Milan
country: Italy
facility: Radiologia Senologica
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Madrid
country: Spain
facility: Centro de Patalogia de la Mama-Fundacion Tejerina
city: London
country: United Kingdom
facility: Royal Free Londan NHS Foundation Trust
Study officials:
affiliation: Hologic, Inc.
name: Brad Keller
role: STUDY_DIRECTOR
References: