VisAR Augmented Reality Navigation of Ventriculostomy

Dartmouth Health

Status: Not yet enrolling

Conditions: Subarachnoid Hemorrhage; Obstructive Hydrocephalus; Brain Trauma

Treatments: Device: VisAR

Study type: Interventional

Funder types: Other

Identifiers

NCT06132139

STUDY02002144

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

VisAR Navigation

Experimental group

Description:

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

Treatment:

Device: VisAR

Freehand Navigation

No Intervention group

Description:

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