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VisAR Augmented Reality Navigation of Ventriculostomy

VisAR Augmented Reality Navigation of Ventriculostomy

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06132139
Enrollment
50
Registered
2023-11-15
Start date
2024-10-31
Completion date
2025-05-31
Last updated
2024-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Trauma, Obstructive Hydrocephalus, Subarachnoid Hemorrhage

Brief summary

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.

Detailed description

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.

Interventions

DEVICEVisAR

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

Sponsors

Dartmouth-Hitchcock Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Determining navigation system accuracy based on anatomical location and Kakarla scoring system.During surgeryThe 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.

Contacts

Primary ContactBeverly Allen, B.S.
beverly.a.allen@hitchcock.org603-653-9021

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026