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

A Prospective, Open-Label, Single-Arm, Single-Site, 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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01885741

Enrollment

Registered

2013-06-25

Start date

2013-09-30

Completion date

2014-05-31

Last updated

2017-04-19

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

Conditions

Breast Cancer Diagnosis, Breast Cancer Screening, MRI Guided Breast Biopsy

Brief summary

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.

Interventions

DEVICEIPBS

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Frequency of target reached by the interventional tools as determined by a qualified physician reviewing the MR images.	Day 1

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026