Status:
NOT_YET_RECRUITING
Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
Lead Sponsor:
Sirius Medical Systems B.V.
Collaborating Sponsors:
Avania B.V.
Conditions:
Breast Surgery
Lymph Node Excision
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 a...
Detailed Description
Breast cancer remains one of the most prevalent malignancies affecting women worldwide, necessitating a range of treatment modalities to manage and combat the disease effectively. These modalities inc...
Eligibility Criteria
Inclusion
- 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
- Subject is indicated for primary breast conserving surgery and/or targeted axillary dissection
- 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
- 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)
- Subject is expected to require an MRI scan in the period between implantation and surgery
- Known hypersensitivity to Titanium or Nickel
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06950021
Start Date
July 1 2025
End Date
February 1 2026
Last Update
April 29 2025
Active Locations (1)
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1
Rode Kruis Ziekenhuis
Beverwijk, North Holland, Netherlands, 1942 LE