跳至主要内容
临床试验/NCT06132139
NCT06132139尚未招募不适用

VisAR Augmented Reality Navigation of Ventriculostomy

Dartmouth-Hitchcock Medical Center0 个研究点目标入组 50 人开始时间: 2024年10月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Determining navigation system accuracy based on anatomical location and Kakarla scoring system.

研究概览

简要总结

This study is intended to evaluate the feasibility of using VisAR augmented reality surgical navigation during placement of an external ventricular drain (EVD). The investigators are interested in confirming the design of the VisAR headset is compatible with this bedside procedure.

详细描述

A secondary objective of this study is to compare the accuracy of freehand EVD navigation, the current standard of care, with VisAR augmented reality surgical navigation. The intent is to demonstrate the advantages to the patient by the use/application of this next generation navigation technology.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients, 18 years and older, determined to need an external ventricular drain (EVD) or ventriculostomy catheter by the attending neurosurgeon secondary to a variety of pathologies, including obstructive hydrocephalus, trauma and subarachnoid hemorrhage.

排除标准

  • Patients less than 18 years of age.
  • Pregnant women.
  • Prisoners.

结局指标

主要结局

Determining navigation system accuracy based on anatomical location and Kakarla scoring system.

时间窗: During surgery

The accuracy of VisAR in placement of EVDs primary assessment will be graded based on the anatomical location of the EVD, known as the Kakarla scoring system. The Kakarla scoring system has 3 grades of accuracy of placement based on the location of the catheter tip.

次要结局

未报告次要终点

研究者

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

Jennifer Hong

Principal Investigator

Dartmouth-Hitchcock Medical Center

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