Breast Cancer Clinical Trial
Official title:
IGAR-Breast Teleoperative Clinical Investigation
The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.
In this prospective clinical trial, patients who present to the breast cancer clinic at one
of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis
or staging will be screened consecutively. Patients who meet the inclusion criteria will be
approached for consent to participate in the study. Upon consent, each participant will
undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while
the radiologist operates the system from a remote site. All consenting participants will be
followed up for the assessment of the secondary outcome measure.
A total of 5-10 participants will be consented for the pilot investigation.
Each individual subject's participation is estimated to last approximately one week post
procedure, with the trial itself expected to be completed within one year of its start date.
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