- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06132139
VisAR Augmented Reality Navigation of Ventriculostomy
March 4, 2024 updated by: Jennifer Hong, Dartmouth-Hitchcock Medical Center
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Beverly Allen, B.S.
- Phone Number: 603-653-9021
- Email: beverly.a.allen@hitchcock.org
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VisAR Navigation
Patients randomly assigned to this arm will have their EVD placed using VisAR navigation.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Hong, M.D., Dartmouth-Hitchcock Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 1, 2024
Primary Completion (Estimated)
May 1, 2024
Study Completion (Estimated)
May 1, 2024
Study Registration Dates
First Submitted
September 21, 2023
First Submitted That Met QC Criteria
November 9, 2023
First Posted (Actual)
November 15, 2023
Study Record Updates
Last Update Posted (Estimated)
March 6, 2024
Last Update Submitted That Met QC Criteria
March 4, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Craniocerebral Trauma
- Trauma, Nervous System
- Intracranial Hemorrhages
- Brain Injuries
- Hemorrhage
- Brain Injuries, Traumatic
- Subarachnoid Hemorrhage
- Hydrocephalus
Other Study ID Numbers
- STUDY02002144
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subarachnoid Hemorrhage
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingSubarachnoid Hemorrhage, Aneurysmal | Subarachnoid Hemorrhage, SpontaneousItaly
-
Assiut UniversityNot yet recruitingPost-Traumatic Subarachnoid Hemorrhage
-
Medical University InnsbruckRecruitingSubarachnoid Hemorrhage | Subarachnoid Hemorrhage, Aneurysmal | Aneurysmal Subarachnoid Hemorrhage | Vasospasm, CerebralAustria
-
IRCCS San RaffaeleFondazione Policlinico Universitario Agostino Gemelli IRCCS; Azienda Ospedaliera... and other collaboratorsRecruitingSubarachnoid Hemorrhage, Aneurysmal | Poor Grade Subarachnoid HemorrhageItaly
-
Methodist Health SystemRecruitingTraumatic Intracranial Subarachnoid HemorrhageUnited States
-
University of CalgaryUnknownIntraventricular Hemorrhage | Aneurysmal Subarachnoid HemorrhageCanada
-
Macmillan Research Group UKCenter for Applied Research & Education; SMS Medical College and HospitalCompletedTraumatic Subarachnoid Haemorrhage
-
Odense University HospitalUnknownSubarachnoid Hemorrhage.Denmark
-
University of Texas Southwestern Medical CenterRecruitingSubarachnoid Hemorrhage, AneurysmalUnited States
-
Milton S. Hershey Medical CenterRecruiting