Percutaneous Excision Trial

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00720642

Acronym

I-PET

Enrollment

1170

Registered

2008-07-23

Start date

2006-07-31

Completion date

2011-06-30

Last updated

2012-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Imaged Breast Abnormalities

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results