Feasibility of Measuring Cerebrospinal Fluid (CSF) Signatures in Subjects With Intrathecal Catheter-Related Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis
研究概览
简要总结
The purpose of this study is to record signatures from the fluid surrounding the spinal cord from people who have an implanted drug infusion system.
详细描述
The purpose of this feasibility study is to record cerebrospinal fluid (CSF) signatures from subjects who have an implanted drug infusion system and who undergo clinical tests designed to troubleshoot possible catheter-related problems as part of their normal standard of care. Signatures will be correlated with physician-determined catheter status.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 12 years of age
- •Have an implanted Medtronic drug infusion system for chronic intrathecal administration of drugs
- •Report decreased therapeutic benefit, or show visible signs and/or symptoms of decreased therapeutic benefit
- •Agree to undergo clinical tests designed to troubleshoot catheter-related problems or failure as a part of their normal standard of care
- •Agree to provide signed informed consent.
排除标准
- •Are currently enrolled or plan to enroll in another investigational drug or device trial
- •Have participated in an investigational drug or device study within 30 days of the in-clinic visit
- •Whose health status would, in the opinion of the Clinical Investigator, be jeopardized by participation in the study
结局指标
主要结局
Classification of Catheter Function by CSF Signatures vs. Physician's Standard Trouble-shooting Diagnosis
时间窗: 1 day
Collect and characterize, by comparison with the physician's standard trouble-shooting diagnosis, CSF signatures recorded in subjects who have an infusion system who present with signs and/or symptoms of possible catheter-related problems or failure.
次要结局
- The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Cough(1 day)
- The Relationship Between Catheter Flow Resistance Check Data and Physician's Standard Trouble-shooting Diagnosis(1 day)
- The Relationship Between CSF Pressure Data and Physician's Standard Trouble-shooting Diagnosis During Physical Task Protocol: Valsalva(1 day)