Percutaneous Excision Trial

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.

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Key information

Conditions

Imaged Breast Abnormalities

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Arkansas for Medical Services, Little Rock, Arkansas, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Intact Medical Corporation

Industry

Registry information

Official study 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.

Acronym: I-PET

Important dates

Study start: 2006
Primary completion: 2011
Study completion: 2011
First posted: Jul 23, 2008
Registry last updated: Sep 12, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.