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Clinical Trials/NCT06132139
NCT06132139
Not Yet Recruiting
N/A

VisAR Augmented Reality Navigation of Ventriculostomy

Dartmouth-Hitchcock Medical Center0 sites50 target enrollmentOctober 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obstructive Hydrocephalus
Sponsor
Dartmouth-Hitchcock Medical Center
Enrollment
50
Primary Endpoint
Determining navigation system accuracy based on anatomical location and Kakarla scoring system.
Status
Not Yet Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2024
End Date
May 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Hong

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

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.

Outcomes

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.

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