Percutaneous Excision Trial

Completed

Conditions studied: Imaged Breast Abnormalities

In brief

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.

Key facts

Study ID

NCT00720642

Run by

Intact Medical Corporation

People needed

1170

Starts

2006-07-01

Expected to finish

2011-06-01

Last updated by the study team

2012-09-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Arkansas for Medical Services — Little Rock, Arkansas, United States
• The Breast Health Center — Indio, California, United States
• Long Beach Memorial Breast Center — Long Beach, California, United States
• The Hill Breast Center — Pasadena, California, United States
• Flagler Hospital — Saint Augustine, Florida, United States
• Center for Breast Care HCA — West Palm Beach, Florida, United States
• Metro Surgical Associates, Inc. — Lithonia, Georgia, United States
• TIFT Regionald Medical Center — Tifton, Georgia, United States
• Maui Medical Group — Wailuku, Hawaii, United States
• Shawnee Mission Medical Center — Overland Park, Kansas, United States
• St. Joseph Medical Center — Towson, Maryland, United States
• Mercy Medical Center — Springfield, Massachusetts, United States
• Genesys Medical Center — Grand Blanc, Michigan, United States
• Saint Luke's Cancer Institute — Kansas City, Missouri, United States
• Lourdes Hospital Breast Center — Binghamton, New York, United States
• Wilson Hospital Breast Center — Johnson City, New York, United States
• Jewish Hospital Breast Center — Cincinnati, Ohio, United States
• University of Cincinnati The Barrett Center — Cincinnati, Ohio, United States
• Elyria Memorial Hospital — Elyria, Ohio, United States
• St. John West Shore Hospital — Westlake, Ohio, United States
• Evangelical Hospital — Lewisburg, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Coastal Carolina Breast Center — Murrells Inlet, South Carolina, United States
• Nashville Breast Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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