VisAR Augmented Reality Navigation of Ventriculostomy

NCT06132139 | Not Yet Recruiting

• 1 other identifier: STUDY02002144
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obstructive Hydrocephalus; Subarachnoid Hemorrhage; Brain Trauma

Outcome Measures

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.

  During surgery

Study Arms (2)

VisAR Navigation

EXPERIMENTAL

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

Device: VisAR

Freehand Navigation

NO INTERVENTION

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

Interventions

VisAR DEVICE

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

VisAR Navigation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients less than 18 years of age.
• Pregnant women.
• Prisoners.

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead

MeSH Terms

Conditions

Hydrocephalus; Subarachnoid Hemorrhage; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jennifer Hong, M.D.

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beverly Allen, B.S.

CONTACT

603-653-9021; beverly.a.allen@hitchcock.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: November 15, 2023
• Study Start: October 1, 2024
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: August 7, 2024

Record last verified: 2024-08