Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1170 participants
OBSERVATIONAL
2006-07-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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PSAP
This is the population of patients in whom surgical intervention could possibly be avoided. These patients will be those in whom all imaging evidence (mammographic or sonographic) was removed during the Intact BLES procedure, and in whom a definitive diagnosis of ADH could be made using the pathology assessment criteria outlined in the protocol.
No interventions assigned to this group
NPSAP
Patients with a pathology diagnosis of ADH in whom all imaging evidence (mammographic or sonographic) of the target lesion was NOT removed OR in whom a definitive diagnosis of ADH COULD NOT be made by implementing the pathology criteria for evaluation outlined in the protocol AND patients with a diagnosis of DCIS will undergo open surgical excision and will be analyzed separately from the PSAP group.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patient must have had an imaged abnormality found via mammography or sonography that warrants a biopsy for further diagnosis
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Intact Medical Corporation
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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Intact 06-06
Identifier Type: -
Identifier Source: org_study_id