Safety & Performance of CANOpus PINtuition Surgical Marker Navigation

NCT06950021 | Not Yet Recruiting

• 2 other identifiers: CANOPINNL-MF-000010932
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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 aims to answer are:

• 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.

Conditions

Breast Surgery; Lymph Node Excision

Keywords

Breast conserving surgery; magnetic seed localization; pintuition; breast sparing surgery; surgical localization; surgical navigation

Outcome Measures

Primary Outcomes (2)

• 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%

  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.

  From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)

Secondary Outcomes (9)

• Radiologist's Satisfaction

  Post-procedural (implantation)

• Surgeon Satisfaction

  Post-procedural (surgery)

• Subject Satisfaction

  At post-operative check (2 weeks follow-up visit)

• Safety: Adverse Events

  From enrolment to the follow-up visit at 2 weeks after surgery (estimated 3-5 weeks)

• Accuracy of Placement

  Post-procedural (implantation)

Study Arms (1)

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

Device: Magnetic seed

Interventions

Magnetic seed DEVICE

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.

Primary breast lesion and/or axillary lymph node localisation prior to surgical excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sirius Medical Systems B.V.: lead
• Avania B.V.: collaborator

Study Sites (1)

Rode Kruis Ziekenhuis

Beverwijk, North Holland, 1942 LE, Netherlands

Location

Central Study Contacts

Bram Schermers, CEO/CTO

CONTACT

+31 6 48044508; bram.schermers@sirius-medical.com

Kitty Kempen Kempen, PhD, Clinical Affairs Director

CONTACT

+31 6 10223238; kitty.kempen@sirius-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 29, 2025
• Study Start: July 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

NL (1)