Trials / Completed
CompletedNCT03300206
A Post-Market Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
A Prospective, Block Stratified Clinical Trial to Evaluate the Performance and Operation of the Brevera Breast Biopsy System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 525 (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 as compared to the current standard-of-care breast biopsy procedures
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Breast Biopsy | 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
- 2017-09-13
- Primary completion
- 2019-03-19
- Completion
- 2019-03-19
- First posted
- 2017-10-03
- Last updated
- 2024-12-04
- Results posted
- 2024-12-04
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03300206. Inclusion in this directory is not an endorsement.