Clinical Research Directory
Browse clinical research sites, groups, and studies.
Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization
Sponsor: The Cooper Health System
Summary
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?
Official title: Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization: A Randomized Controlled Clinical Trial (PEARL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-07-01
Completion Date
2026-03-31
Last Updated
2025-06-27
Healthy Volunteers
No
Interventions
EVD placement - image-guidance assisted
During EVD placement, an image-guided noninvasive systems will be used to assist the operator for EVD catheter tip navigation through a burr hole opening. The use of image-guidance system occurs once during initial EVD placement in this trial.
EVD placement - AR assisted
During EVD placement, an AR system will be used to assist the operator for EVD catheter tip navigation through a burr hole opening. The use of AR occurs once during initial EVD placement in this trial.
Locations (1)
Cooper University Health
Camden, New Jersey, United States