Menu
Not yet recruiting NCT07042048

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

No phase Interventional ICH - Intracerebral Hemorrhage IVH- Intraventricular Hemorrhage TBI Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: EVD placement - image-guidance assisted, EVD placement - AR assisted.
Who it may be relevant to
Registry conditions: ICH - Intracerebral Hemorrhage, IVH- Intraventricular Hemorrhage, TBI Traumatic Brain Injury. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

Interventions

  • 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.

Primary outcome measures

  • Successful EVD catheter placement [Time frame: During procedure]
  • rate of complication during placement [Time frame: During procedure]
Secondary outcome measures (8)
  • rate of catheter tip dispositions [Time frame: During procedure]
  • number of passes for placement [Time frame: During procedure]
  • rate of AR or Stealth overlay failures on first try [Time frame: During procedure]
  • rate of EVD failure [Time frame: from placement to removal of EVD and assessed up to two weeks after]
  • EVD dislodgment of occlusion [Time frame: from placement to removal of EVD and assessed up to two weeks after]
  • rate of EVD replacement or revision [Time frame: During procedure]
  • rate of EVD associated hemorrhage [Time frame: from placement to removal of EVD and assessed up to two weeks after]
  • rate if EVD-associated infection [Time frame: from placement to removal of EVD and assessed up to two weeks after]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Cooper University Health — Camden

Identifiers

NCT: NCT07042048 · 25-168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗