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

Breast Lesions Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03520127
• Other study ID #: 63-10-2356
• Status: Terminated
• Start date: September 27, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: May 2019
• Source: Medtronic Surgical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 176
• Est. completion date: February 28, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Lesions

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Surgical Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lesion BIRADS score	Diagnostic imaging result	Weeks prior to the Intact procedure
Primary	Imaging lesion size	Measured in mm	Weeks prior to the Intact procedure
Primary	Lesion histology	Lesion biopsy results	Weeks prior to the Intact procedure
Primary	Tissue margin (as reported from histology) rate	Procedure margin vs. margin size, measured in mm	Weeks after the Intact procedure, up to approximately 12 weeks
Primary	Underestimation rate	Compared to maximum lesion size, measured in mm	Weeks after the Intact procedure, up to approximately 12 weeks