VisAR Augmented Reality Navigation of Ventriculostomy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDartmouth-Hitchcock Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patients less than 18 years of age.
Pregnant women.
Prisoners.
Trial design
Design model
Parallel
Treatments tested in this trial
VisAR
DeviceThe study device is a Microsoft HoloLens which uses Novarad's proprietary software and is collectively known as VisAR.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: VisAR NavigationExperimental treatment 1 intervention
Group B: Freehand NavigationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
During surgeryLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: