Percutaneous Excision Trial
- Conditions
- Imaged Breast Abnormalities
- Registration Number
- NCT00720642
- Lead Sponsor
- Intact Medical Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1170
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision. Post Intact Excision
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
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
🇺🇸St. 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
Scroll for more (14 remaining)University of Arkansas for Medical Services🇺🇸Little Rock, Arkansas, United States