VisAR Augmented Reality Navigation of Ventriculostomy

Subarachnoid Hemorrhage Clinical Trial

Official title:

VisAR Augmented Reality Navigation of Ventriculostomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06132139
• Other study ID #: STUDY02002144
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2024
• Est. completion date: May 2025

Study information

• Verified date: June 2024
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Beverly Allen, B.S.
• Phone: 603-653-9021
• Email: beverly.a.allen[@]hitchcock.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 2025
• Est. primary completion date: May 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Brain Trauma
• Hemorrhage
• Hydrocephalus
• Obstructive Hydrocephalus
• Subarachnoid Hemorrhage

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determining navigation system accuracy based on anatomical location and Kakarla scoring system.	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.	During surgery