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

Cooper University Health Care

Status: Not yet enrolling

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

Treatments: Device: EVD placement - image-guidance assisted; Device: EVD placement - AR assisted

Study type: Interventional

Funder types: Other

Identifiers

NCT07042048

25-168

Details and patient eligibility

About

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?

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Augmented Reality Assistance

Experimental group

Description:

Placement of EVDs using augmented reality device

Treatment:

Device: EVD placement - AR assisted

Stealth Image-guided assistance

Active Comparator group

Description:

Placement of EVDs using Stealth image-guidance

Treatment:

Device: EVD placement - image-guidance assisted