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Safety & Performance of CANOpus PINtuition Surgical Marker Navigation

Sirius Medical Systems B.V. · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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The goal of this clinical trial is to evaluate the safety and performance of the Canopus Marker in adult breast cancer patients who are scheduled for breast-conserving surgery. The main questions it aims to answer are: 1. Can the Canopus Marker be safely and effectively used to mark tissue for surgical removal? 2. What is the satisfaction level of radiologists, surgeons, and patients with the use of the Canopus Marker? Participants will: * Have the Canopus Marker implanted into the tumor or nearby tissue using ultrasound guidance. * Undergo surgery where the Canopus Marker will help guide the surgeon to the tumor, and the marker will be removed along with the tumor. This surgery is performed using an FDA cleared and CE-marked detection device (Sirius Pintuition Detector). * Attend a follow-up visit two weeks after surgery to assess any adverse events and overall satisfaction.
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