VisAR Augmented Reality Navigation of Ventriculostomy

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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Key information

Conditions

Obstructive Hydrocephalus Brain Diseases Brain Injuries Brain Injuries, Traumatic Brain Trauma Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Hydrocephalus Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

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

Treatment and study plan

VisAR

Device

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

Primary outcomes

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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Beverly Allen, B.S.

CONTACT

[email protected]

603-653-9021

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Nov 15, 2023
Registry last updated: Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed