Trials / Terminated
TerminatedNCT03520127
A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 176 (actual)
- Sponsor
- Medtronic Surgical Technologies · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Intact Breast Lesion Excision System (BLES) | Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure. |
Timeline
- Start date
- 2017-09-27
- Primary completion
- 2019-02-15
- Completion
- 2019-02-28
- First posted
- 2018-05-09
- Last updated
- 2019-05-16
Locations
7 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03520127. Inclusion in this directory is not an endorsement.