跳至主要内容
临床试验/NCT05432986
NCT05432986已完成不适用

Assessment of Flow in Cerebrospinal Fluid Shunts With a Wireless Thermal Anisotropy Measurement Device, Phase B

Rhaeos, Inc.9 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2022年7月7日最近更新:
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
141
试验地点
9
主要终点
Study Device Sensitivity

研究概览

简要总结

This study evaluates the performance of a non-invasive thermal measurement device for assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction will be evaluated with the study device.

详细描述

Patients with an existing implanted ventriculoperitoneal (VP) shunt and who are experiencing shunt malfunction symptoms will be recruited by the clinical investigators at each investigational site in accordance with the inclusion and exclusion criteria. Assessment of shunt flow will be performed non-invasively with the study device; physician and clinical staff will be blinded to the device result. Standard-of-care assessment of shunt function will be performed and surgical intervention will occur based on the judgement of the treating neurosurgeon without the use of study device data. This trial will evaluate the ability of the study device to identify shunt malfunctions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Study Device Sensitivity

时间窗: 7-day follow-up period

Study device sensitivity is calculated as TP / (TP + FN), where TP = true positive and FN = false negative.

Study Device Specificity

时间窗: 7-day follow-up period

Study device specificity is calculated as TN / (TN + FP), where TN = true negative and FP = false positive.

次要结局

未报告次要终点

研究者

发起方
Rhaeos, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (9)

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