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NCT Number: NCT07042048

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

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?

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Key information

Conditions

ICH - Intracerebral Hemorrhage Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage IVH- Intraventricular Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms TBI Traumatic Brain Injury Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Successful EVD catheter placement

    Time frame: During procedure

    Post-procedural non-contrast head CT will be reviewed by masked assessor to evaluate success of EVD placement per the Kakarla grading system. This grading system classifies catheter positioning into three grades based on postoperative imaging. Grade 1 indicates optimal placement in the ipsilateral frontal horn or third ventricle for effective drainage. Grade 2 represents functional but non-ideal placement in the contralateral ventricle or non-eloquent cortex. Grade 3 denotes suboptimal placement in eloquent cortex or non-target spaces, potentially leading to complications. Thus, a higher score means a worse outcome.

  2. rate of complication during placement

    Time frame: During procedure

Secondary outcomes

  1. rate of catheter tip dispositions

    Time frame: During procedure

  2. number of passes for placement

    Time frame: During procedure

  3. rate of AR or Stealth overlay failures on first try

    Time frame: During procedure

  4. rate of EVD failure

    Time frame: from placement to removal of EVD and assessed up to two weeks after

  5. EVD dislodgment of occlusion

    Time frame: from placement to removal of EVD and assessed up to two weeks after

  6. rate of EVD replacement or revision

    Time frame: During procedure

  7. rate of EVD associated hemorrhage

    Time frame: from placement to removal of EVD and assessed up to two weeks after

  8. rate if EVD-associated infection

    Time frame: from placement to removal of EVD and assessed up to two weeks after

Study contacts

Contact information is provided by the study sponsor or research team.

Corey Mossop, MD

CONTACT

[email protected]

856-342-2000

Sponsors and collaborators

Lead sponsor

The Cooper Health System

Other

Registry information

Official study title

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

Acronym: PEARL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 27, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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