Safety and Performance of the Polaris® 24 Adjustable Valve System in Hydrocephalus Patients' Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sophysa
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Valve replacement
研究概览
简要总结
The SAPPHYRE study is an ambispective (retrospective and prospective) PMCF study with the objective to evaluate the safety and performance of the Polaris® 24 adjustable valve system in the treatment of 126 patients with hydrocephalus.
详细描述
The SAPPHYRE study is an ambispective (retrospective and prospective), non-interventional, multicenter, post-market clinical follow-up study. The study objective is to evaluate the safety and performance of Sophysa's CE marked Polaris® 24 adjustable valve system in the treatment of hydrocephalus by shunting the cerebrospinal fluid. It is expected to recruit 126 patients in two-year. Patients will be followed-up up to 5 years post-procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient implanted with the Polaris® 24 adjustable valve system for the following reasons:
- •Primo implant of a valve shunt-based derivation system, or as a
- •Replacement of another valve -based shunt system, or
- •Endoscopic ventriculostomy (EVT) failure
- •Patient having given his/her informed consent prior to inclusion in this study, as per local regulations
排除标准
- •Confirmed or suspected infections along the length of the shunt (meningitis, ventriculitis, peritonitis, septicemia or bacteremia) or any infection present in any part of the body
- •Patient on anticoagulant therapy, or presenting with bleeding diathesis, or with haemorrhagic CSF, as the presence of blood in the system could lead to an obstruction in the system
- •Ventriculo-atrial shunts in patient suffering from congenital cardiopathies or other malformations of the cardio-pulmonary system
结局指标
主要结局
Valve replacement
时间窗: 1 year
Primary performance outcome will be assessed by the incidence of valve replacements
Device-related SAE / complications
时间窗: 1 year
Primary safety outcome will be assessed by the incidence of device-related serious adverse events / complications
次要结局
- Implant procedure success(0 day (post-procedure))
- Change of clinical status scores(One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation)
- Evolution of Clinical symptoms(One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation)
- All adverse events / complications(Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation)
- Valve replacement(Two (2) years post procedure, and yearly thereafter, up to five (5) years post implantation)
- MRI stability(One (1) year, two (2) years, and yearly thereafter, up to five (5) years post implantation)
- Valve pressure adjustment((if applicable), throughout the follow-up period: One (1) year, two (2) years, and and yearly thereafter, up to five (5) years post implantation)