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

NCT ID: NCT07042048

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Augmented Reality Assistance

Placement of EVDs using augmented reality device

Group Type: EXPERIMENTAL

EVD placement - AR assisted

Intervention Type: DEVICE

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.

Stealth Image-guided assistance

Placement of EVDs using Stealth image-guidance

Group Type: ACTIVE_COMPARATOR

EVD placement - image-guidance assisted

Intervention Type: DEVICE

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.

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cooper Health System

OTHER

Sponsor Role: lead

Responsible Party

Corey Mossop

Neurosurgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cooper University Health

Camden, New Jersey, United States

Countries

United States

Central Contacts

Corey Mossop, MD

Role: CONTACT

mossop-corey@cooperhealth.edu

856-342-2000

Facility Contacts

Corey Mossop, MD

Role: primary

mossop-corey@cooperhealth.edu

856-342-2000

Other Identifiers

25-168

Identifier Type: -

Identifier Source: org_study_id