SIR-CI-001

Sirius Medical Systems B.V.0 个研究点目标入组 30 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 at least 18 years of age
•3.Patient is diagnosed with a single, pathologically confirmed unifocal breast tumour (DCIS or invasive)
•4.The tumour is ultrasound visible
•5.Patient is indicated for primary breast conserving surgery
•6.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 an 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 within 5cm of 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 Magnetic Seed and surgery exceeds 30 days

发起方

Sirius Medical Systems B.V.