Post-Market Clinical Follow-up Registry of Patients With CODMAN CERTAS Plus Programmable Valves
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 8
- 主要终点
- Performance Endpoints
研究概览
简要总结
Post-Market Clinical Follow-up Registry of Patients with CODMAN CERTAS Plus Programmable Valves.
详细描述
The CODMAN CERTAS Plus Programmable Valve is a single use implantable device designed for shunting cerebrospinal fluid (CSF) for the treatment of hydrocephalus.
The clinical investigation specifically aims to collect data on the performance measures outlined below. Data will be collected per standard of care, given the nature of the clinical investigation to capture real world data (registry); timing, frequency, and methodology of assessing the performance outcomes may therefore differ per center, subject, and/or visit.
- Improvement of the following symptoms related to hydrocephalus:
- Gait disturbances;
- Spatial impairment;
- Cognitive abilities;
- Urinary incontinence;
- Pain caused by headaches;
- Visual acuity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-80 years old at time of enrollment) undergoing implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
- •Patients willing and able to understand and sign informed consent.
排除标准
- 未提供
结局指标
主要结局
Performance Endpoints
时间窗: 1 month, 3 months, 6 months, 12 months, 24 months, and 36 months
The change from baseline for the following symptoms related to hydrocephalus, e.g. gait disturbances, spatial impairment, cognitive abilities, urinary incontinence, pain caused by headaches and visual acuity.
次要结局
- Device Deficiencies(1 month, 3 months, 6 months, 12 months, 24 months, and 36 months)