Post-Market Clinical Follow-up Registry of the Integra External Ventricular Drainage Systems and Accessories
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Cerebrospinal; Disorder
- 发起方
- Integra LifeSciences Corporation
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Anticipated Drainage of Cerebrospinal Fluid (CSF)
- 状态
- 已完成
- 最后更新
- 3个月前
概览
简要总结
This post-market follow-up registry will capture clinical data specific to the safety and performance of the Integra External Ventricular Drainage Systems and Accessories.
详细描述
The purpose of this study is to investigate whether the Integra External Ventricular Drainage System listed as part of this study do perform to clinical expectations. Additionally, this study will focus on the safety of these devices by collecting any device-specific Adverse Events (AEs) or Device deficiencies (DDs) seen when used during standard of care procedures.
研究者
入排标准
入选标准
- •Patient and/or legally authorized representative has agreed to participate in the study by signing the EC-approved consent form, where applicable.
- •Patients (of any age) who underwent or who plan to have a procedure with one of the Integra or Codman External Ventricular Drainage System.
- •For patients who have had the EVD System removed prior to study enrollment, have available follow-up data from implant until the EVD System is no longer required for drainage and monitoring of CSF.
排除标准
- •The Patients in whom more than one EVD System were or are intended to be placed.
- •The Patient has sepsis.
- •The Patient has a history of poor wound healing.
- •The patient exhibits signs of scalp infection prior to implantation that would be contraindicated per the IFU.
- •The Patient is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
- •The Patient is currently enrolled in another device trial or has been previously entered in this trial.
- •The Patient is a prisoner or member of a different vulnerable population that should not be included in the study per the investigator.
- •The Patients known to have uncorrected coagulopathy.
- •The Patients with known hypersensitivity to rifampin or clindamycin hydrochloride (prior to implantation of Bactiseal catheters)
结局指标
主要结局
Anticipated Drainage of Cerebrospinal Fluid (CSF)
时间窗: 1 month following device implantation
Percentage of subjects with anticipated drainage (i.e., observed drainage consistent with the patient's clinical presentation) of cerebrospinal fluid (CSF) in the clinical setting until the EVD System is no longer required.
次要结局
- Success of the Access to the Intracranial Space(1 month following device implantation)