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Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
Sponsor: Sirius Medical Systems B.V.
Summary
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.
Official title: Safety & Performance of CANOpus PINtuition Surgical Marker Navigation (CANOPIN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
35
Start Date
2025-07-01
Completion Date
2026-02-01
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
Magnetic seed
All patients enrolled will receive a single Sirius Canopus Marker with two anchors added to it for improved tissue fixation. Implantation will be done by a radiologist before breast conserving surgery, usually scheduled within a few days after Canopus Marker implantation. The Canopus Marker is removed with the specimen during the surgery.
Locations (1)
Rode Kruis Ziekenhuis
Beverwijk, North Holland, Netherlands