NCT06753929已完成不适用
Assessment of Flow in Cerebrospinal Fluid Shunts with a Wireless Thermal Anisotropy Measurement Device During Routine Outpatient Surveillance Visits
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Rhaeos, Inc.
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
This study collects exploratory data using a non-invasive device for assessing CSF shunt flow using thermal anisotropy measurements. Patients with an existing implanted ventricular CSF shunt will be enrolled into either a prospective (study device) or retrospective (no study device) cohort to gather data on health resource utilization, quality-of-life, and study device measurements.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing ventricular cerebrospinal fluid shunt
- •Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
- •Subject available for 2 week follow-up
- •Region of intact skin overlying an unambiguously identifiable palpable chronically indwelling ventricular shunt that crosses the clavicle; region of skin is appropriate in size for application of the study device (Cohort A only)
排除标准
- •Presence of more than one distal shunt catheter in the study device measurement region
- •Presence of an interfering open wound or edema in the study device measurement region
- •Subject-reported history of serious adverse skin reactions to silicone-based adhesives
- •Participation in the study will interfere with, or be detrimental to, the administration of optimal health care to the subject
结局指标
主要结局
Quality of Life
时间窗: 14 days
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. A PROMIS T-score of 50 represents the general population norm, and each 10-point deviation represents one standard deviation from the norm. Higher scores equals more of the concept being measured (e.g., more Fatigue, more Physical Function).
次要结局
未报告次要终点
研究者
研究点 (2)
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