Clinical Trial for the Validation of AR Based Neuronavigation System

Condition(s) studied

Investigational drug(s) / intervention(s)

AR-based navigation: The surgeon will perform all surgical planning and operations with reference to the existing navigation. In this process, the errors of the existing navigation and the newly developed navigation are measured and compared in 3D at several points, and the points are as follows. 1. Fiducial markers 2. Nasion 3. Tumor's margin (anterior, posterior, superior, inferior)

Study summary

The goal of this clinical trial is to test augmented reality (AR) based neuronavigation system in surgeries for patients of brain neoplasm or cerebral vascular disease. The main questions it aims to answer are:

• AR based neuronavigation system can achieve accuracy that is not inferior to conventional intraoperative navigation system.

Participants will participate the study after informed consent. When participants undergo surgery for their brain tumor, we will set up 2 types of neuronavigation, conventional navigation system and developed AR based neuronavigation system. Surgeon will plan and conduct surgery based on only conventional navigation system, but 3D errors at several selected points between two types of navigation will be measured and analyzed.

Eligibility

Primary outcome measure(s)

• The degree of 3-dimensional error at each measurement points (mm) — 6 hours
  Fiducial markers, nasion
• The degree of 3-dimensional error at each measurement points (mm) after durotomy — 6 hours
  Tumor's margin, ICA bifurcation, et al.

Trial sites (1)

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