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

NCT03520127 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 176

Last updated 2019-05-16

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic Surgical Technologies

    lead INDUSTRY

Principal Investigators

  • Lydia Sakakeeny, PhD · Medtronic Surgical Technologies

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-27
Primary Completion
2019-02-15
Completion
2019-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03520127 on ClinicalTrials.gov