NCT07042048

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

Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization: A Randomized Controlled Clinical Trial (PEARL)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: The Cooper Health System · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

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

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2025-06-27
• Last updated: 2025-06-27

Locations

1 site across 1 country: United States