Premarket study to assess safety and performance of the Orion Magnetic Localization System for breast cancer - Orion-1

Sirius Medical Systems B.V0 个研究点目标入组 33 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•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

•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

发起方

Sirius Medical Systems B.V