VisAR Augmented Reality Navigation of Ventriculostomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-31

Study Completion Date

2025-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Hydrocephalus Subarachnoid Hemorrhage Brain Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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VisAR Navigation

Patients randomly assigned to this arm will have their EVD placed using VisAR navigation.

Group Type EXPERIMENTAL

VisAR

Intervention Type DEVICE

The study device is a Microsoft HoloLens which uses Novarad's proprietary software and is collectively known as VisAR.

Freehand Navigation

Patients randomly assigned to this arm will have their EVD placed using freehand navigation, the typical standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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VisAR

The study device is a Microsoft HoloLens which uses Novarad's proprietary software and is collectively known as VisAR.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.