Premarket study to assess safety and performance of the Orion Magnetic Localization System for breast cancer

Completed

Conditions: breast cancer
ductal carcinoma in situ
invasive ductal carcinoma
10006291

Registration Number: NL-OMON48270

Lead Sponsor: Sirius Medical Systems B.V

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 33

Inclusion Criteria

1. Patient is willing and able to provide informed consent for the
investigation and to comply to the schedule of assessments of the clinical
investigation
2. Patient is female
3. Patient is at least 18 years of age
4. Patient is diagnosed with a single, pathologically confirmed unifocal breast
tumour (DCIS or invasive)
5. Tumour is ultrasound visible
6. Patient is indicated for primary breast conserving surgery
7. Patient is indicated for preoperative localization using a single
(radioactive) seed

Exclusion Criteria

1. Patient is pregnant;
2. Patient is receiving neo-adjuvant chemotherapy
3. Patient has and ICD or other active implant such as a pacemaker less than
5cm away from the intended target location
4. Patient has a proven infection or hematoma at or close to the intended
target location
5. Patient is scheduled for immediate breast reconstruction (within the same
surgical procedure)
6. Patient is currently participating in, or has recently exited from, or plans
to be enrolled in another clinical investigation which may affect the outcomes
of the current clinical investigation, as assessed by the discretion of the
investigator
7. Patient is expected to require an MRI scan of the breast area in the period
between implantation and surgery
8. The expected time between placement of ORION SEED and surgery exceeds 30
days

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Performance. Number and percentage of procedures in which ORION SEEDS is<br /><br>present on post-operative specimen X-ray and only the ORION detector is used<br /><br>during surgery [=>95%]<br /><br>2) Safety. Adverse events as assessed by MedDRA.Number and percentage of<br /><br>patients who experienced a device-related adverse event. [No SADEs]</p><br>

Secondary Outcome Measures