A Prospective, Multicenter Study to Evaluate the Performance and Safety of the CerebroFlo™ EVD Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 20
- 主要终点
- Number of flushing interventions to address occlusions
研究概览
简要总结
The primary goal of this study is to assess the occurrence of flushing interventions to address occlusions during the treatment of interventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm).
详细描述
Potential study candidates will be screened for inclusion and exclusion criteria after informed consent has been provided by the Legally Acceptable Representative and/or the study candidate.
Once enrolled in the study, data will be collected from those subjects with elevated intracranial pressure (ICP), interventricular hemorrhage, or hydrocephalic shunt infections as a result of the use of the EVD catheter.
Pre-insertion and peri-removal CT scans and neurological assessment data will also be collected.
Data will be collected for subjects beginning from the time of hospital admission through discharge and followed by the 30 Day and 90 Day Follow up Visits.
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
- •Subject and/or legally authorized representative has reviewed the Institutional Review Board (IRB)-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the IRB-approved consent form.
- •Subject is ≥ 18 years of age at the time of consent.
- •Subjects with intraventricular hemorrhage (spontaneous primary IVH or secondary IVH due to ruptured aneurysm) who have had CerebroFlo™ EVD Catheter(s) placed without complication.
- •Subjects who require only one EVD Catheter at initial admission
排除标准
- •Subjects with a scalp infection present.
- •Subjects with uncorrectable coagulopathy due to prior administration of anticoagulants at the time the CerebroFlo™ EVD Catheter(s) is placed.
- •Subjects known to have a bleeding diathesis.
- •Subjects in which the CerebroFlo™ EVD Catheter(s) is placed directly into a hematoma
- •Evidence of catheter-associated hemorrhage from insertion of the CerebroFlo EVD Catheter(s) on post-placement CT scan.
- •Subject is pregnant
结局指标
主要结局
Number of flushing interventions to address occlusions
时间窗: study device implantation through study device removal
The number of flushing interventions from initial catheter placement through catheter removal, an average of 10 days, to address occlusions.
次要结局
- Assessment of Glasgow Coma Score (GCS)(Device implantation through to 90-Day follow-up)
- Assessment of National Institute of Health Stroke Scale (NIHSS)(Device implantation through to 90-Day follow-up)
- Change of hemorrhage volume(Device implantation through to 90-Day follow-up)
- Assessment of Modified Rankin Score (mRS)(Device implantation through to 90-Day follow-up)