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

Stopped early

Conditions studied: Breast Lesions

In brief

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

Key facts

Study ID

NCT03520127

Run by

Medtronic Surgical Technologies

People needed

176

Starts

2017-09-27

Expected to finish

2019-02-28

Last updated by the study team

2019-05-16

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Birmingham Breast Care — Birmingham, Alabama, United States
• Winship Cancer Institute-Emory St. Joseph's — Atlanta, Georgia, United States
• Dalton Surgical Group — Dalton, Georgia, United States
• Metro Surgical Associates Inc. — Lithonia, Georgia, United States
• Holyoke Medical Center — Holyoke, Massachusetts, United States
• Nashville Breast Center — Nashville, Tennessee, United States
• The Breast Center at Chesapeake Regional Healthcare — Chesapeake, Virginia, United States

Full record on ClinicalTrials.gov

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