An interventional study of Magnetic seed in Breast Surgery and Lymph Node Excision, sponsored by Sirius Medical Systems B.V.. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Sirius Medical Systems B.V. · Not applicable, Interventional, and Other
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:
Participants will:
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.
This is the only study on the registry with Sirius Medical Systems B.V. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: CANOPUS Magnetic Marker by Sirius Medical Systems B.V. Placement of experimental device in primary breast lesion and/or axillary lymph node indicated for surgical removal and requiring localisation
Device: 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.
Performance: Retrieval Rate
Proportion of procedures in which the Canopus marker is present on post-operative specimen X-ray and only the Pintuition Detector is used during surgery. Hypothesis: =\> 85%
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Safety: Investigational Device-Related Serious Adverse Device Effects
Proportion of patients who experienced an investigational device-related serious adverse device effect as assessed by MedDRA. Hypothesis: none.
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Radiologist's Satisfaction
The secondary performance endpoints and hypotheses of this clinical investigation include: an overall radiologist satisfaction score of ≥7 measured on a 10-point Likert scale or comparable index
Time frame: Post-procedural (implantation)
Surgeon Satisfaction
The secondary performance endpoints and hypotheses of this clinical investigation include: an overall surgical satisfaction score of ≥7 measured on a 10-point Likert scale or comparable index
Time frame: Post-procedural (surgery)
Subject Satisfaction
The secondary performance endpoints and hypotheses of this clinical investigation include: an overall subject satisfaction score of ≥7 measured on a 10-point Likert scale or comparable index
Time frame: At post-operative check (2 weeks follow-up visit)
Safety: Adverse Events
Secondary safety endpoints include the reporting of the incidence, severity and causal relationship of adverse events (AEs), adverse device effects (ADEs), serious adverse events (SAEs), unanticipated serious adverse device events (USADEs) and device deficiencies (DDs) in accordance with ISO 14155:2020 definitions
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Accuracy of Placement
Average distance between Canopus Marker centre and tumour centre on the two post-placement mammographic images in mm
Time frame: Post-procedural (implantation)
Operative Time
Minutes from first incision until wound closure
Time frame: Post-procedural (surgery)
Transcutaneous Detection Succesful
Proportion of procedures in which a reliable signal of the Canopus Marker is detected on the intact skin using the Pintuition Detector
Time frame: Periprocedural (surgery)
Marker Dislodgements
Proportion of procedures in which the Marker dislodged during the surgical procedure.
Time frame: Post-procedural (surgery)
Reoperation Rate
Second, separate surgical procedure of same lesion or area indicated after multidisciplinary discussion
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Plan to share: Undecided
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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