VisAR Augmented Reality Navigation of Ventriculostomy

Not Applicable

Not yet recruiting

• Conditions: Obstructive Hydrocephalus; Subarachnoid Hemorrhage; Brain Trauma
• Interventions: Device: VisAR

• Registration Number: NCT06132139
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-06
• Last Update Posted: 2024-08-07
• Study Start: 2024-10
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VisAR Navigation	VisAR	Patients randomly assigned to this arm will have their EVD placed using VisAR navigation.

Primary Outcome Measures

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