A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

Medtronic

Status: Terminated

Conditions: Breast Lesions

Treatments: Device: Intact Breast Lesion Excision System (BLES)

Study type: Observational

Funder types: Industry

Identifiers

NCT03520127

63-10-2356

Details and patient eligibility

About

The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.

Enrollment: 176 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

176 participants in 1 patient group

Females, 18 years of age or older

Description:

Females, 18 years of age or older, who will undergo the Intact procedure

Treatment:

Device: Intact Breast Lesion Excision System (BLES)