Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSirius Medical Systems B.V.
About this trial
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.
Eligibility criteria
Qualifiers
Subject is willing and able to provide informed consent for the investigation
Subject is at least 18 years of age
Subject is diagnosed with a single, pathologically confirmed unifocal breast tumour (DCIS or invasive)
Tumour is ultrasound visible
Disqualifiers
Subject is lactating or pregnant
Subject is expected to have surgery scheduled more than 6 weeks after implantation of the Canopus Marker.
Subject has an ICD or other active implant such as a pacemaker less than 5 cm away from the intended target location(s)
Subject has a proven infection or clinically significant hematoma at or close to the intended target location(s)
Trial design
Treatments tested in this trial
- Magnetic seed
Treatment groups
35 Participants
are divided into 1 treatment groupSponsors and collaborators
Sirius Medical Systems B.V.
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov