VisAR Augmented Reality Navigation of Ventriculostomy

• Sponsor: Dartmouth-Hitchcock Medical Center (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06132139
• Collaborator: (none)
• Enrollment: 50
• Arms: 2
• Anticipated Duration (Months): 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Hydrocephalus; Subarachnoid Hemorrhage; Brain Trauma	Device: VisAR	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: VisAR Augmented Reality Navigation of Ventriculostomy
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VisAR Navigation Patients randomly assigned to this arm will have their EVD placed using VisAR navigation.	Device: VisAR; The study device is a Microsoft HoloLens which uses Novarad's proprietary software and is collectively known as VisAR.
No Intervention: Freehand Navigation Patients randomly assigned to this arm will have their EVD placed using freehand navigation, the typical standard of care.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Dartmouth-Hitchcock Medical Center

Investigators

• Principal Investigator: Jennifer Hong, M.D., Dartmouth-Hitchcock Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jennifer Hong, Principal Investigator, Dartmouth-Hitchcock Medical Center
• ClinicalTrials.gov Identifier: NCT06132139
• Other Study ID Numbers: STUDY02002144
• First Posted: Nov 15, 2023
• Last Update Posted: Nov 15, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Hydrocephalus; Brain Injuries, Traumatic; Hemorrhage

Study Results

No Results Posted as of Nov 15, 2023