Clinical trial NCT00720642: Percutaneous Excision Trial
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Imaged Breast Abnormalities
Lead sponsor: Intact Medical Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-23
Enrollment: 1170
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an imaged breast abnormality found with mammography or sonography whose initial biopsy will be taken with the Intact BLES.

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 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

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