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Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.


N/A
18 Years
N/A
Not Enrolling
Female
Imaged Breast Abnormalities

Thank you

Trial Information

Percutaneous Excision Trial (I-Pet): A Multi-Center Clinical Study Of The Intact Breast Lesion Excision System (Bles) To Demonstrate That A Definitive Diagnosis Can Be Made From The Tissue Sample Collected With The Intact Bles.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

Post Intact Excision

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

Intact 06-06

NCT ID:

NCT00720642

Start Date:

July 2006

Completion Date:

June 2011

Related Keywords:

  • Imaged Breast Abnormalities
  • Congenital Abnormalities

Name

Location

Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Long Beach Memorial Breast Center Long Beach, California  90806
Shawnee Mission Medical Center Shawnee Mission, Kansas  66204
St. Joseph Medical Center Towson, Maryland  21204
Saint Luke's Cancer Institute Kansas City, Missouri  64111
Nashville Breast Center Nashville, Tennessee  37203
University of Arkansas for Medical Services Little Rock, Arkansas  72205
The Breast Health Center Indio, California  92201
The Hill Breast Center Pasadena, California  91105
Flagler Hospital St. Augustine, Florida  32086
Center for Breast Care HCA West Palm Beach, Florida  33407
Metro Surgical Associates, Inc. Lithonia, Georgia  30058
TIFT Regionald Medical Center Tifton, Georgia  31793
Maui Medical Group Wailuku, Hawaii  96793
Mercy Medical Center Springfield, Massachusetts  01102
Genesys Medical Center Grand Blanc, Michigan  48439
Lourdes Hospital Breast Center Binghamton, New York  13905
University of Cincinnati The Barrett Center Cincinnati, Ohio  45267-0772
Jewish Hospital Breast Center Cincinnati, Ohio  45236
Elyria Memorial Hospital Elyria, Ohio  44035
St. John West Shore Hospital Westlake, Ohio  44145
Evangelical Hospital Lewisburg, Pennsylvania  17837
Coastal Carolina Breast Center Murrells Inlet, South Carolina  29576
Wilson Hospital Breast Center Johnson City, New York  13790