Safety & Performance of CANOpus PINtuition Surgical Marker Navigation

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 include surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy. Among these, breast-conserving surgery (BCS), also known as lumpectomy, has become a cornerstone of breast cancer treatment. BCS involves the removal of the cancerous tissue while preserving as much of the breast as possible. This approach aims to achieve oncologic safety comparable to mastectomy while offering psychological and cosmetic benefits. The success of BCS has been augmented by advancements in imaging techniques and surgical tools, facilitating precise tumour localization and excision.

Over the years, various localization technologies have been developed to enhance the precision of breast cancer surgeries. Traditional methods like wire localization have been widely used but are often associated with discomfort and logistical challenges. Advances in medical technology have led to non-wire localization methods such as radioactive seed localization (RSL) and radar systems. The commercially available Sirius Pintuition system, using magnetic seed localization, involves inserting a small magnetic marker into the tumour site, detectable with a magnetic probe during surgery. This system aims to offer advantages like improved subject comfort, precise localization, and ease of use for surgeons. The investigational Canopus Marker, building on Sirius Pintuition's success, aims to further improve the precision and effectiveness of breast-conserving surgeries. The Canopus Marker incorporates additional anchoring mechanisms designed to enhance its stability during breast-conserving surgeries. These enhancements aim to mitigate any potential risk of dislodgement, while maintaining the marker's detectability and ease of use for surgeons.

The present investigation is only evaluating if the additional anchors added to the Pintuition Marker, which is the Canopus Marker, is also safe and performing as intended. Therefore, the present investigation will be similar in design as the study that was conducted to obtain the Pintuition System's CE mark. That is, a single-arm, open-label study in one centre in The Netherlands. The sample size (n=35) is determined to demonstrate that the Canopus Marker does not perform worse than the Pintuition Marker and other similar marker-based localization devices.

• Radiologist's Satisfaction [Срок оценки: Post-procedural (implantation)]
• Surgeon Satisfaction [Срок оценки: Post-procedural (surgery)]
• Subject Satisfaction [Срок оценки: At post-operative check (2 weeks follow-up visit)]
• Safety: Adverse Events [Срок оценки: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)]
• Accuracy of Placement [Срок оценки: Post-procedural (implantation)]
• Operative Time [Срок оценки: Post-procedural (surgery)]
• Transcutaneous Detection Succesful [Срок оценки: Periprocedural (surgery)]
• Marker Dislodgements [Срок оценки: Post-procedural (surgery)]
• Reoperation Rate [Срок оценки: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)]