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
NCT01885741 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9
Last updated 2017-04-19
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.
Conditions
- Breast Cancer Screening
- MRI Guided Breast Biopsy
- Breast Cancer Diagnosis
Interventions
- DEVICE
-
IPBS
Sponsors & Collaborators
- lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2014-03-31
- Completion
- 2014-05-31
Countries
- Canada
Study Locations
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