A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-27

Study Completion Date

2019-02-28

Brief Summary

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The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.

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Detailed Description

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Conditions

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Breast Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Females, 18 years of age or older

Females, 18 years of age or older, who will undergo the Intact procedure

Intact Breast Lesion Excision System (BLES)

Intervention Type DEVICE

Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.

Interventions

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Intact Breast Lesion Excision System (BLES)

Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female
* Age ≥ 18 years
* BIRADS ≤ 5, as initially imaged
* Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used

Exclusion Criteria

* Male
* Subjects with subglandular (pre-pectoral, or "single plane") breast implants
* Subjects with electronic implantable devices (such as pacemakers and defibrillators)
* Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No