A Secondary Study Evaluating Performance and Safety of Aqueduct's Smart External Drain (SED2)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 6
- 主要终点
- The number of subjects which require switching to a standard of care external drain.
研究概览
简要总结
Aqueduct's Smart External Drain (SED) will be compared to the current gold standard for temporary CSF management in a hospital setting.
- Evaluate the number of subjects requiring to be switched to a standard of care EVD
- Evaluate subject transport while on the SED
- Evaluate SED system control from initiation of SED through discharge of external drain system
详细描述
This clinical trial will evaluate Aqueduct's Smart External Drain (SED) upon implementation of ventriculostomy or lumbar drain placement for temporary CSF external management in a hospital setting. Subjects will remain on study from the time of SED application through discharge of the external drain or switch to standard of care extraventricular drain.
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
- — 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject scheduled to have an external drain (includes extra-ventricular and lumbar drains) placed as part of routine management.
- •Able to obtain consent or legally authorized representative (LAR) consents for subject to be treated on study.
排除标准
- •Anticoagulant therapy (does not include DVT or PE prophylaxis).
- •Known bleeding diathesis.
- •Scalp infection.
- •In the opinion of the Investigator the subject is not a good study candidate.
研究组 & 干预措施
Single Arm Study
All subjects enrolled on study will utilize Aqueduct's Smart External Drain (SED) from the time of external drain implementation until end of study upon discharge of SED or switch to standard of care external drain.
干预措施: Smart External Drain - SED (Device)
结局指标
主要结局
The number of subjects which require switching to a standard of care external drain.
时间窗: The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days.
Evaluating the number of subjects which require switching to a standard of care external drain versus the number of subjects which remain on the SED until study completion or discharge of the external drain.
次要结局
- Subject transport while on the SED system.(Subject transport review and data collection will begin when the patient is moved from their primary hospital bed location until they reach a new secondary location or are returned to the primary location. Assessed up to 90 days.)
- Evaluating SED system control throughout duration of study.(The study review and data collection period will begin at the time SED is connected to the ventriculostomy catheter until discharge of ventriculostomy catheter; when subject no longer requires an external drain, assessed up to 90 days.)