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

Starting soon · Not applicable

Conditions studied: ICH - Intracerebral Hemorrhage, IVH- Intraventricular Hemorrhage, TBI Traumatic Brain Injury

In brief

The goal of this clinical trial is to assess if EVD placement using augmented reality is non inferior to image-guidance systems for assistance in adult patients needing an EVD for spontaneous ICH with IVH or severe TBI. The main question it aims to answer is: Can EVDs be placed successfully with at least equal safety and efficacy using augmented reality devices in comparison to using standard image-guidance techniques?

Key facts

Study ID

NCT07042048

Run by

The Cooper Health System

People needed

50

Starts

2025-07-01

Expected to finish

2026-03-31

Last updated by the study team

2025-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• Tissue swelling on imaging Dysmorphic ventricles on imaging Midline shift >2mm on imaging Mass effect on imaging Evans Index <0.3 on imaging Glasgow Coma Scale 3-8
• admitted to Cooper University Health
• requires an EVD

You may not qualify if…

• 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

Where it is running

• Cooper University Health — Camden, New Jersey, United States

Full record on ClinicalTrials.gov

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