Breast SurgeryCANOPINNCT06950021
Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
A study testing Magnetic seed in people with Breast Surgery and Lymph Node Excision, run by Sirius Medical Systems B.V. at 1 site in Netherlands.
Trial 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 aims to answer are: 1. Can the Canopus Marker be safely and effectively used to mark tissue for surgical removal? 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Surgery, Lymph Node Excision
- What is being tested?
- Magnetic seed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2025to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kitty Kempen Kempen, PhD, Clinical Affairs Director contact
Netherlands1 site
Rode Kruis Ziekenhuis
Beverwijk, North Holland, 1942 LE
Carlinda Bresser, Research Coordinator
Niels Harlaar, Surgeon
About this study
Official title: Safety & Performance of CANOpus PINtuition Surgical Marker Navigation (CANOPIN)
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:
- Can the Canopus Marker be safely and effectively used to mark tissue for surgical removal?
- What is the satisfaction level of radiologists, surgeons, and patients with the use of the Canopus Marker?
Read more
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.
Read the 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 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.
- Conditions
- Breast Surgery, Lymph Node Excision
- Being tested
- Magnetic seed
- Keywords
- Breast conserving surgery, magnetic seed localization, pintuition, breast sparing surgery, surgical localization, surgical navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic seedDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary breast lesion and/or axillary lymph node localisation prior to surgical excision | Experimental | 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 Receives: Device: Magnetic seed |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: 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.
Measured: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Secondary outcomes (9)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Post-procedural (implantation)
Operative Time
Minutes from first incision until wound closure
Measured: 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
Measured: Periprocedural (surgery)
Marker Dislodgements
Proportion of procedures in which the Marker dislodged during the surgical procedure.
Measured: Post-procedural (surgery)
Reoperation Rate
Second, separate surgical procedure of same lesion or area indicated after multidisciplinary discussion
Measured: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sirius Medical Systems B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06950021
- Sponsor's protocol ID
- CANOPIN
- Other IDs
- NL-MF-000010932
- Acronym
- CANOPIN
- Status last verified
- Apr 2025
- First submitted
- 15 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Performance of CANOpus PINtuition Surgical Marker Navigation (CANOPIN)
- ClinicalTrials.gov ID
- NCT06950021
- Acronym / sponsor ID
- CANOPIN / CANOPIN
- Conditions
- Breast Surgery, Lymph Node Excision
- Keywords
- Breast conserving surgery, magnetic seed localization, pintuition, breast sparing surgery, surgical localization, surgical navigation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Sirius Medical Systems B.V.Industry (pharma, biotech, devices)
- Collaborators
- Avania
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can the Canopus Marker be safely and effectively used to mark tissue for surgical removal?
- 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.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary breast lesion and/or axillary lymph node localisation prior to surgical excision | Experimental | Device: Magnetic seedDevice: 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic seedAll 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. | Device | Primary breast lesion and/or axillary lymph node localisation prior to surgical excision |
Primary outcome
Performance: Retrieval Rate
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
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%
Safety: Investigational Device-Related Serious Adverse Device Effects
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Proportion of patients who experienced an investigational device-related serious adverse device effect as assessed by MedDRA. Hypothesis: none.
9 secondary outcomes
Radiologist's Satisfaction
Time frame: Post-procedural (implantation)
Surgeon Satisfaction
Time frame: Post-procedural (surgery)
Subject Satisfaction
Time frame: At post-operative check (2 weeks follow-up visit)
Safety: Adverse Events
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Accuracy of Placement
Time frame: Post-procedural (implantation)
Operative Time
Time frame: Post-procedural (surgery)
Transcutaneous Detection Succesful
Time frame: Periprocedural (surgery)
Marker Dislodgements
Time frame: Post-procedural (surgery)
Reoperation Rate
Time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kitty Kempen Kempen, PhD, Clinical Affairs Director contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic seed in people with Breast Surgery and Lymph Node Excision, run by Sirius Medical Systems B.V. at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bram Schermers, CEO/CTO (+31 6 48044508, bram.schermers@sirius-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance: Retrieval Rate (time frame: From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.