Breast sparing surgery
Conditions
Interventions
The investigational device is the Sirius Canopus Marker, which is similar to the CE-marked Sirius Pintuition Marker with two tiny anchors added to it for improved tissue fixation. The marker will be i
Sponsors
Sirius Medical Systems B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Subject is willing and able to provide informed consent for the investigation 2. Subject is at least 18 years of age 3. Subject is diagnosed with a single, pathologically confirmed unifocal breast tumour (DCIS or invasive) 4. Tumour is ultrasound visible 5. Subject is indicated for primary breast conserving surgery and/or targeted axillary dissection 6. 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
Exclusion criteria
Exclusion criteria: 1. Subject is lactating or pregnant 2. Subject is expected to have surgery scheduled more than 6 weeks after implantation of the Canopus Marker. 3. Subject has an ICD or other active implant such as a pacemaker less than 5 cm away from the intended target location(s) 4. Subject has a proven infection or hematoma at or close to the intended target location(s) 5. Subject is expected to require an MRI scan in the period between implantation and surgery 6. Known hypersensitivity to Titanium or Nickel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Performance Endpoint is successful retrieval rate of Canopus Markers that were correctly placed, as documented by imaging. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Performance Endpoints and Hypotheses:1) An overall radiologist satisfaction score of =7 measured on a 10-point Likert scale or comparable index. 2) An overall surgical satisfaction score of =7 measured on a 10-point Likert scale or comparable index. 3) An overall subject satisfaction score of =3 measured on a 5-point Likert scale or comparable index. Safety Endpoints and Hypothesis:The primary safety endpoint and hypothesis is no investigational device-related serious adverse device effects (SADEs) through study completion in any subject.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 | — |
Countries
Netherlands
Contacts
Public ContactK. Kempen
Sirius Medical Systems B.V.
Outcome results
None listed