Percutaneous Excision Trial

N/ACompletedNCT00720642

Intact Medical Corporation1,170 enrolled

Overview

To confirm that a definitive diagnosis can be made from the tissue sample collected using the Intact BLES when defined radiology and pathology criteria are met.

Study Type

OBSERVATIONAL

Enrollment

1,170

Conditions

Imaged Breast Abnormalities

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Patient must be a female at least 18 years of age at the time of Intact BLES biopsy * Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis Exclusion Criteria: * Patients who have pre-pectoral breast implants * Patients who have implantable devices such as pacemakers and defibrillators * Patients who are pregnant or lactating * Patients in whom the device is contraindicated * Patients who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed or who exhibit fever or other clinical evidence of infection

Locations (24)

University of Arkansas for Medical Services

Little Rock, Arkansas, United States

Outcomes

Primary Outcomes

The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision.

Time frame: Post Intact Excision

Data from ClinicalTrials.gov

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