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临床试验/NCT04883060
NCT04883060已完成不适用

Pilot Testing for Midline Measuring Device

University of Iowa1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Midline Localization

研究概览

简要总结

Identifying the exact middling on the patient's head during the planning phase of surgery is crucial yet can be challenged by patient's head position and hair. The investigators have invented a device that uses anatomical landmark to quickly and gracefully identify the midline on a patient's head. The device is a U-shaped instrument equipped with a laser pointer at the midline. The instrument also has smooth spheres that can be positioned over the patients' ears bilaterally. The midline laser pointer will identify the midline on the patients' head. this measurement procedure is typically done after the patient is placed under anesthesia. The standard way of determining the midline on the skull is simply by surgeon's vision without any measurements. This new technique will be contrasted against the standard way. The device was invented by investigators in neurosurgery (led by Dr. Matthew Howard III). This is not patented it at this time. There is no company involved in manufacturing (assembly was completed with the help of the hospital's machine shop).

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
21 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with normal pressure hydrocephalus who are scheduled to undergo a ventriculoperitoneal shunt surgery

排除标准

  • •Patients who are not able to consent

研究组 & 干预措施

Intervention

Experimental

Patients undergoing ventriculoperitoneal surgery where the midline localizer was used

干预措施: midline localizer (Device)

结局指标

主要结局

Midline Localization

时间窗: Immediate postop, an average of 4 hours

The average distance separating the staple from the lateral edge of the sagittal sinus

次要结局

  • Burr Hole Placement(Immediately Post-op, an average of 4 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Matthew Howard

Professor of Neurosurgery, Head of Department of Neurosurgery at University of Iowa

University of Iowa

研究点 (1)

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