Percutaneous Excision Trial (I-PET)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intact Medical Corporation
ClinicalTrials.gov Identifier:
NCT00720642
First received: July 21, 2008
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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.


Condition
Imaged Breast Abnormalities

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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.

Further study details as provided by Intact Medical Corporation:

Primary Outcome Measures:
  • The proportion of patients in various populations who undergo an Intact procedure with an upgrade in the diagnosis after undergoing an open surgical excision. [ Time Frame: Post Intact Excision ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Breast lesion tissue


Enrollment: 1170
Study Start Date: July 2006
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00720642

  Show 24 Study Locations
Sponsors and Collaborators
Intact Medical Corporation
  More Information

No publications provided

Responsible Party: Intact Medical Corporation
ClinicalTrials.gov Identifier: NCT00720642     History of Changes
Other Study ID Numbers: Intact 06-06
Study First Received: July 21, 2008
Last Updated: September 11, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on April 17, 2014