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

Part of paid clinical trials in Camden, New Jersey.

Sponsor
The Cooper Health System
Study ID
NCT07042048
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EVD placement - image-guidance assisted — 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.
  • EVD placement - AR assisted — 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.

Study Details

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 Dates

Start date
Jul 1, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2025
Completion
Mar 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Augmented Reality Assistance
    Placement of EVDs using augmented reality device
  • Active Comparator: Stealth Image-guided assistance
    Placement of EVDs using Stealth image-guidance

Primary Outcome Measure

Successful EVD catheter placement [ Time Frame: During procedure ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cooper University HealthCamdenNew Jersey08103
Corey Mossop, MD
[email protected]
856-342-2000

Find similar trials in Camden, NJ

By research site
Cooper University Health· Camden, NJ

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