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

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

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

Study Overview

• Status: Terminated
• Conditions: Breast Lesions
• Intervention / Treatment: Device: Intact Breast Lesion Excision System (BLES)

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Birmingham Breast Care
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Winship Cancer Institute-Emory St. Joseph's
    • Dalton, Georgia, United States, 30720
      • Dalton Surgical Group
    • Lithonia, Georgia, United States, 30058
      • Metro Surgical Associates Inc.
  • Massachusetts
    • Holyoke, Massachusetts, United States, 01040
      • Holyoke Medical Center
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Nashville Breast Center
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • The Breast Center at Chesapeake Regional Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Subjects who have undergone the Intact procedure that are female and 18 years of age or older.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Females, 18 years of age or older; Females, 18 years of age or older, who will undergo the Intact procedure	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion BIRADS score	Diagnostic imaging result	Weeks prior to the Intact procedure
Imaging lesion size	Measured in mm	Weeks prior to the Intact procedure
Lesion histology	Lesion biopsy results	Weeks prior to the Intact procedure
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
Underestimation rate	Compared to maximum lesion size, measured in mm	Weeks after the Intact procedure, up to approximately 12 weeks

Collaborators and Investigators

• Sponsor: Medtronic Surgical Technologies
• Investigators: Study Director: Lydia Sakakeeny, PhD, Medtronic Surgical Technologies

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2017
• Primary Completion (Actual): February 15, 2019
• Study Completion (Actual): February 28, 2019

Study Registration Dates

• First Submitted: April 5, 2018
• First Submitted That Met QC Criteria: May 8, 2018
• First Posted (Actual): May 9, 2018

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 15, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 63-10-2356

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No