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

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ClinicalTrials.gov Identifier: NCT03520127
Recruitment Status : Terminated (Product withdrawn from the market due to a shift in sponsor business focus)
First Posted : May 9, 2018
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Breast Lesions Device: Intact Breast Lesion Excision System (BLES)

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Study Type : Observational [Patient Registry]
Actual Enrollment : 176 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Month
Official Title: A Multi-center Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)
Actual Study Start Date : September 27, 2017
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : February 28, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

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.




Primary Outcome Measures :
  1. Lesion BIRADS score [ Time Frame: Weeks prior to the Intact procedure ]
    Diagnostic imaging result

  2. Imaging lesion size [ Time Frame: Weeks prior to the Intact procedure ]
    Measured in mm

  3. Lesion histology [ Time Frame: Weeks prior to the Intact procedure ]
    Lesion biopsy results

  4. Tissue margin (as reported from histology) rate [ Time Frame: Weeks after the Intact procedure, up to approximately 12 weeks ]
    Procedure margin vs. margin size, measured in mm

  5. Underestimation rate [ Time Frame: Weeks after the Intact procedure, up to approximately 12 weeks ]
    Compared to maximum lesion size, measured in mm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who have undergone the Intact procedure that are female and 18 years of age or older.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520127


Locations
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United States, Alabama
Birmingham Breast Care
Birmingham, Alabama, United States, 35205
United States, Georgia
Winship Cancer Institute-Emory St. Joseph's
Atlanta, Georgia, United States, 30342
Dalton Surgical Group
Dalton, Georgia, United States, 30720
Metro Surgical Associates Inc.
Lithonia, Georgia, United States, 30058
United States, Massachusetts
Holyoke Medical Center
Holyoke, Massachusetts, United States, 01040
United States, Tennessee
Nashville Breast Center
Nashville, Tennessee, United States, 37203
United States, Virginia
The Breast Center at Chesapeake Regional Healthcare
Chesapeake, Virginia, United States, 23320
Sponsors and Collaborators
Medtronic Surgical Technologies
Investigators
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Study Director: Lydia Sakakeeny, PhD Medtronic Surgical Technologies
Additional Information:

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Responsible Party: Medtronic Surgical Technologies
ClinicalTrials.gov Identifier: NCT03520127    
Other Study ID Numbers: 63-10-2356
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No