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

NCT03520127 | Terminated

• 1 other identifier: 63-10-2356
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Lesions

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (1)

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)

Interventions

Intact Breast Lesion Excision System (BLES) DEVICE

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.

Females, 18 years of age or older

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• Medtronic Surgical Technologies: lead

Study Sites (7)

Birmingham Breast Care

Birmingham, Alabama, 35205, United States

Location

Winship Cancer Institute-Emory St. Joseph's

Atlanta, Georgia, 30342, United States

Location

Dalton Surgical Group

Dalton, Georgia, 30720, United States

Location

Metro Surgical Associates Inc.

Lithonia, Georgia, 30058, United States

Location

Holyoke Medical Center

Holyoke, Massachusetts, 01040, United States

Location

Nashville Breast Center

Nashville, Tennessee, 37203, United States

Location

The Breast Center at Chesapeake Regional Healthcare

Chesapeake, Virginia, 23320, United States

Location

Study Officials

• Lydia Sakakeeny, PhD

  Medtronic Surgical Technologies

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: May 9, 2018
• Study Start: September 27, 2017
• Primary Completion: February 15, 2019
• Study Completion: February 28, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

US (7)