Status:
COMPLETED
Percutaneous Excision Trial
Lead Sponsor:
Intact Medical Corporation
Conditions:
Imaged Breast Abnormalities
Eligibility:
FEMALE
18+ years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
1170 Patients enrolled
Trial Details
Trial ID
NCT00720642
Start Date
July 1 2006
End Date
June 1 2011
Last Update
September 12 2012
Active Locations (24)
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1
University of Arkansas for Medical Services
Little Rock, Arkansas, United States, 72205
2
The Breast Health Center
Indio, California, United States, 92201
3
Long Beach Memorial Breast Center
Long Beach, California, United States, 90806
4
The Hill Breast Center
Pasadena, California, United States, 91105