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

Terminated

• Conditions: Breast Lesions
• Interventions: Device: Intact Breast Lesion Excision System (BLES)

• Registration Number: NCT03520127
• Lead Sponsor: Medtronic Surgical Technologies

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-27
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-09
• Primary Completion: 2019-02-15
• Study Completion: 2019-02-28
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-15
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 176

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Females, 18 years of age or older	Intact Breast Lesion Excision System (BLES)	Females, 18 years of age or older, who will undergo the Intact procedure

Primary Outcome Measures

Name	Time	Method
Lesion histology	Weeks prior to the Intact procedure	Lesion biopsy results
Lesion BIRADS score	Weeks prior to the Intact procedure	Diagnostic imaging result
Imaging lesion size	Weeks prior to the Intact procedure	Measured in mm
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

Trial Locations

Locations (7)

Birmingham Breast Care; 🇺🇸 Birmingham, Alabama, United States

Dalton Surgical Group; 🇺🇸 Dalton, Georgia, United States

Metro Surgical Associates Inc.; 🇺🇸 Lithonia, Georgia, United States

Winship Cancer Institute-Emory St. Joseph's; 🇺🇸 Atlanta, 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