Breast Lesions
Conditions
Brief 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.
Interventions
DEVICEIntact 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.
Sponsors
Medtronic Surgical Technologies
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female * Age ≥ 18 years * BIRADS ≤ 5, as initially imaged * Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used
Exclusion criteria
* Male * Subjects with subglandular (pre-pectoral, or single plane) breast implants * Subjects with electronic implantable devices (such as pacemakers and defibrillators) * Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion BIRADS score | Weeks prior to the Intact procedure | Diagnostic imaging result |
| Imaging lesion size | Weeks prior to the Intact procedure | Measured in mm |
| Lesion histology | Weeks prior to the Intact procedure | Lesion biopsy results |
| Tissue margin (as reported from histology) rate | Weeks after the Intact procedure, up to approximately 12 weeks | Procedure margin vs. margin size, measured in mm |
| Underestimation rate | Weeks after the Intact procedure, up to approximately 12 weeks | Compared to maximum lesion size, measured in mm |
Countries
United States
Outcome results
None listed