Safety & Performance of CANOpus PINtuition Surgical Marker Navigation

Launched by SIRIUS MEDICAL SYSTEMS B.V. · Apr 22, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called the Canopus Marker, designed to help surgeons locate and remove tumors in breast cancer patients. The main goals are to check if the marker can be safely placed in or near the tumor before surgery and to see how satisfied patients, surgeons, and radiologists are with its use. Patients who participate will have the Canopus Marker inserted using ultrasound to guide the placement. During surgery, the marker will help the surgeon find the tumor, and it will be removed along with the tumor itself. After the operation, participants will return for a follow-up visit two weeks later to discuss their experience and any side effects.

To take part in this trial, participants need to be at least 18 years old and have one visible breast tumor that requires surgery. They should not be pregnant or nursing, and certain medical conditions or previous treatments could exclude them from participating. The trial is not yet recruiting patients, but it offers a chance to contribute to research that could improve breast cancer surgery in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is willing and able to provide informed consent for the investigation
• • 2. Subject is at least 18 years of age
• • 3. Subject is diagnosed with a single, pathologically confirmed unifocal breast tumour (DCIS or invasive)
• • 4. Tumour is ultrasound visible
• • 5. Subject is indicated for primary breast conserving surgery and/or targeted axillary dissection
• • 6. Subject is indicated for preoperative localization using a single marker in the primary breast lesion and/or a single marker in an axillary lymph node
• Exclusion Criteria:
• • 1. Subject is lactating or pregnant
• • 2. Subject is expected to have surgery scheduled more than 6 weeks after implantation of the Canopus Marker.
• • 3. Subject has an ICD or other active implant such as a pacemaker less than 5 cm away from the intended target location(s)
• • 4. Subject has a proven infection or clinically significant hematoma at or close to the intended target location(s)
• • 5. Subject is expected to require an MRI scan in the period between implantation and surgery
• • 6. Known hypersensitivity to Titanium or Nickel