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

NCT07042048 | Not Yet Recruiting

• 1 other identifier: 25-168
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

EVD; Augmented Reality; TBI; ICH; Image Guidance

Outcome Measures

Primary Outcomes (2)

• Successful EVD catheter placement

  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.

  During procedure

• rate of complication during placement

  During procedure

Secondary Outcomes (8)

• rate of catheter tip dispositions

  During procedure

• number of passes for placement

  During procedure

• rate of AR or Stealth overlay failures on first try

  During procedure

• rate of EVD failure

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

• EVD dislodgment of occlusion

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

Study Arms (2)

Augmented Reality Assistance

EXPERIMENTAL

Placement of EVDs using augmented reality device

Device: EVD placement - AR assisted

Stealth Image-guided assistance

ACTIVE COMPARATOR

Placement of EVDs using Stealth image-guidance

Device: EVD placement - image-guidance assisted

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.

Stealth Image-guided assistance

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.

Augmented Reality Assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cooper Health System: lead

Study Sites (1)

Cooper University Health

Camden, New Jersey, 08103, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Corey Mossop, MD

CONTACT

856-342-2000; mossop-corey@cooperhealth.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: June 27, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

US (1)