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EVD Placement Using Augmented Reality or Image-Based Localization

This study is for adults who need an external ventricular drain (EVD) due to a brain bleed (intracerebral hemorrhage with intraventricular hemorrhage) or a severe traumatic brain injury (TBI). An EVD is a small tube placed in the brain to drain fluid. Researchers want to see if using augmented reality (AR) to guide EVD placement is as safe and effective as using standard image-guidance systems. You might be eligible if you are an adult with one of these conditions and have certain signs on your brain imaging, like tissue swelling or a shift in brain structures. The main goal is to compare how successfully the EVD is placed and if there are any complications during the procedure.

Study design
This study plans to enroll 50 adult participants. It is an interventional study comparing two different methods for EVD placement.
What's involved
You would undergo an EVD placement procedure, where either an image-guidance system or an augmented reality system will be used to assist the operator.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, successful EVD placement and complication rates, are measured during the procedure itself.

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NCT07042048

Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization

Not Yet Recruiting
NAAges 18+InterventionalTreatment
The Cooper Health System
~50 participants
Updated 2025-06-27 on ClinicalTrials.gov
What's tested:EVD placement - image-guidance assistedEVD placement - AR assisted

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Successful EVD catheter placement
Measured over During procedure
+1 more outcome measured

Conditions

ICH - Intracerebral Hemorrhage
IVH- Intraventricular Hemorrhage
TBI Traumatic Brain Injury

Explore related trials

Cerebral HemorrhageIntraventricular Brain HemorrhageTraumatic Encephalopathy

Where it's being run

1 sites across 1 states
New Jersey1

Who to contact

Corey Mossop, MD
[email protected]
856-342-2000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

adult patient at time of screening
diagnosis of spontaneous ICH with IVH with severe TBI
Meet one or more of the following clinical or radiographic criteria:
admitted to Cooper University Health
requires an EVD

Exclusion

Other concomitant intracranial pathology (e.g., tumor, tumor-related edema/hemorrhage, congenital condition, etc.)
Concurrent participation in another research protocol for investigation of an experimental therapy
Known or suspected inability to adhere to study protocol or protocol requirements, as per the discretion of the investigator

What this trial measures

  • Successful EVD catheter placementDuring procedure

    Post-procedural non-contrast head CT will be reviewed by masked assessor to evaluate success of EVD placement per the Kakarla grading system. This grading system classifies catheter positioning into three grades based on postoperative imaging. Grade 1 indicates optimal placement in the ipsilateral frontal horn or third ventricle for effective drainage. Grade 2 represents functional but non-ideal placement in the contralateral ventricle or non-eloquent cortex. Grade 3 denotes suboptimal placement in eloquent cortex or non-target spaces, potentially leading to complications. Thus, a higher score means a worse outcome.

  • rate of complication during placementDuring procedure