Trials / Completed
CompletedNCT03456583
Brevera™ Breast Biopsy System Data Collection Study
A Prospective Study To Evaluate The Performance And Operation Of The Brevera™ Breast Biopsy System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (actual)
- Sponsor
- Hologic, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Brevera Breast Biopsy System | The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging. A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous. |
Timeline
- Start date
- 2017-11-20
- Primary completion
- 2018-11-20
- Completion
- 2018-11-20
- First posted
- 2018-03-07
- Last updated
- 2024-10-08
- Results posted
- 2024-09-19
Locations
6 sites across 6 countries: France, Germany, Italy, Netherlands, Spain, United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03456583. Inclusion in this directory is not an endorsement.