Safety & Performance of CANOpus PINtuition Surgical Marker Navigation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSirius Medical Systems B.V.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
Magnetic seed
DeviceAll 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.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Primary breast lesion and/or axillary lymph node localisation prior to surgical excisionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)2
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)Secondary outcomes
1
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)2
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)3
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)4
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sirius Medical Systems B.V.
Lead sponsor
Avania
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: