Bone Anchored Port - a Novel Vascular Access for Hemodialysis Treatment
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Device survival probability after one year
研究概览
简要总结
A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear, connected with a double lumen central venous catheter inserted in the jugular vein, and will be used in conjunction with an adapter as a permanent vascular access for hemodialysis treatment.
详细描述
STUDY OBJECTIVE The objective of the clinical investigation is to demonstrate feasibility regarding safety, efficiency and clinical performance of the BAP as a permanent access for chronic haemodialysis therapy in patients with renal failure to reach the certificate European (CE) mark and conduct a post market follow-up study.
PRIMARY ENDPOINT
1) Device survival probability after one year (product - limit estimator of Kaplan-Meier Analysis). An event is the primary failure of BAP, defined by necessity to remove the device: for any medical reason (e.g. infections at wound or mastoid, thrombosis, and severe patient discomfort)
SECONDARY ENDPOINTS
- Performance - Implantation and primary healing process
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for a permanent haemodialysis access
- •Impossibility to construct or revise an AC-Fistula
- •Age > 18 years.
- •Written, informed consent.
- •Availability of vascular imaging of the jugular vein at the implantation site with no contraindication for a jugular vein catheter
排除标准
- •Clinical contraindications for the implantation of a BAP including:
- •known intolerance to any of the BAP materials
- •ongoing infections e.g.
- •mastoiditis / otitis media
- •skin infection in the area of presumed implantation-site
- •generalized acute and chronic infections
- •severe skin lesions (e.g. dermatitis, psoriasis) in the area of the presumed implantation site
- •previous surgery at the petrous bone
- •known significant bleeding disorder
- •known thrombophilia
- •Life expectancy less than 1 year from the time of enrolment in the study.
- •Expected transplantation within the intended study duration (i.e. known living donor).
- •Pregnancy or breast feeding.
- •Women of childbearing potential without appropriate contraceptive method.
- •Patient known to be HIV, hepatitis C or hepatitis B antigen positive.
- •Any form of substance abuse, psychiatric disorder or condition which, in the opinion of the investigator may complicate communication with the investigator.
- •Participation in another clinical study (medicinal, medical device) within the last 30 days.
- •Multiple participation of one subject in this clinical investigation.
- •Inability to understand German and to give written informed consent.
- •Patients suffering from epilepsy, addiction or other condition resulting in a higher risk of falling.
结局指标
主要结局
Device survival probability after one year
时间窗: up to 12 months after Study start
An event is the primary failure of BAP, defined by necessity to remove the device for any medical reason (e.g. infections at wound or mastoid, thrombosis, and severe patient discomfort).
次要结局
- Performance - Implantation and primary healing process(up to 18 months after Study start)