Obstructive HydrocephalusNCT06132139
VisAR Augmented Reality Navigation of Ventriculostomy
A study testing VisAR in people with Obstructive Hydrocephalus and Subarachnoid Hemorrhage, run by Dartmouth-Hitchcock Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Hydrocephalus, Subarachnoid Hemorrhage, Brain Trauma
- What is being tested?
- VisAR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients less than 18 years of age.
- Pregnant women.
- Prisoners.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- VisAR
- Medical subject headings
- Hydrocephalus, Subarachnoid Hemorrhage, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisARDevice
The study device is a Microsoft HoloLens which uses Novarad's proprietary software and is collectively known as VisAR.
| Study group | Role | What they receive |
|---|---|---|
| VisAR Navigation | Experimental | Patients randomly assigned to this arm will have their EVD placed using VisAR navigation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study startOct 2024 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive HydrocephalusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Hong, Dartmouth-Hitchcock Medical Center
- Investigators
- Jennifer Hong, M.D., Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132139
- Sponsor's protocol ID
- STUDY02002144
- Status last verified
- Aug 2024
- First submitted
- 21 Sep 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VisAR Augmented Reality Navigation of Ventriculostomy
- ClinicalTrials.gov ID
- NCT06132139
- Acronym / sponsor ID
- STUDY02002144
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Oct 2024 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 15 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VisAR Navigation | Experimental | Device: VisARPatients randomly assigned to this arm will have their EVD placed using VisAR navigation. |
| Freehand Navigation | No intervention | –Patients randomly assigned to this arm will have their EVD placed using freehand navigation, the typical standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients less than 18 years of age.
- Pregnant women.
- Prisoners.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisARThe study device is a Microsoft HoloLens which uses Novarad's proprietary software and is collectively known as VisAR. | Device | VisAR Navigation |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Hong, M.D. principal investigator
Dartmouth-Hitchcock Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing VisAR in people with Obstructive Hydrocephalus and Subarachnoid Hemorrhage, run by Dartmouth-Hitchcock Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beverly Allen, B.S. (603-653-9021, beverly.a.allen@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determining navigation system accuracy based on anatomical location and Kakarla scoring system. (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.