Study to Demonstrate the Preliminary Safety and Effectiveness of IPBS in Performing MRI-Guided Targeting and Intervention of Breast Tissue in Female Patients Indicated for MRI-Guided Breast Biopsy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-05-31

Brief Summary

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A preliminary demonstration of the Safety of IPBS in positioning a vacuum assisted biopsy (VAB) tool to enable an MRI-guided automated breast biopsy. This will consist of 10-15 biopsy procedures facilitated by the MRI-guided system. Patients will be followed after the procedure to assess clinical outcomes.

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Detailed Description

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Conditions

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Breast Cancer Screening MRI Guided Breast Biopsy Breast Cancer Diagnosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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IPBS

Group Type EXPERIMENTAL

IPBS

Intervention Type DEVICE

Interventions

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IPBS

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female patients over the age of 18 with suspected or confirmed breast cancer requiring a manual MRI-guided breast biopsy for diagnosis and staging.
* Individuals Capable of giving a free and informed consent.

Exclusion Criteria

* Any patient for whom the manual MRI-guided breast biopsy procedure would not be possible (size of patient, etc.).
* Patients who refuse the procedure for any reason will be excluded from the study at the investigators discretion.
* Patients who are not suitable for the procedure will be excluded at the investigators discretion.
* Patients unwilling to complete associated study questionnaires or follow up visits.
* Women who are pregnant or who plan to become pregnant within the study duration.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No