Normal Pressure Hydrocephalus (NPH) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 343
- 主要终点
- Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)
研究概览
简要总结
The overall aim of the registry is to develop a longitudinal, observational database that is focused on adult patients with Normal Pressure Hydrocephalus (NPH) that can be used as a source of clinical information for individual surgeons, as well as a national data repository for scientific inquiry and publications.
详细描述
This is a prospective, multi-center, observational database to collect data on the characteristics, management practices, and patient outcomes of NPH patients. It will be offered to a geographically representative group of U.S. physicians who will enroll NPH patients. The physician makes his/her own clinical decisions; thus, the data captured provides current practice patterns related to diagnosis, management, and results. The registry may also assist physicians in patient follow-up and certain practice management tasks. The data collected will serve to inform the medical community on optimal care for this patient population
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Patient meets the diagnosis criteria for Normal Pressure Hydrocephalus
- •Patient is a candidate for a hydrocephalus shunt system, per the discretion of the investigator
- •Patient or legal representative has signed an informed consent form. Competency to sign the consent form will be left up to the discretion of the investigator
排除标准
- •Patient is under the age of 18 years
- •Patient has a known contraindication for a shunt
- •Patient has an expected life span of less than 24 months
- •Patient has an unwillingness or inability to return for required follow-up visits
结局指标
主要结局
Database to describe the population of patients with NPH presenting for treatment (assessed at baseline/no safety assessment)
时间窗: End of trial
次要结局
- To determine frequency of the various treatments for NPH and the outcomes of those treatment (assessed during surgery and at follow-up/no safety assessment)(End of trial)