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Safety & Performance of CANOpus PINtuition Surgical Marker Navigation

NCT06950021 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-29

No results posted yet for this study

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. 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.

Conditions

  • Breast Surgery
  • Lymph Node Excision

Interventions

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.

Sponsors & Collaborators

  • Avania B.V.

    collaborator UNKNOWN

  • Sirius Medical Systems B.V.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-11-01
Completion
2026-02-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06950021 on ClinicalTrials.gov