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

Not Applicable

Not yet recruiting

• Conditions: ICH - Intracerebral Hemorrhage; TBI Traumatic Brain Injury; IVH- Intraventricular Hemorrhage

• Registration Number: NCT07042048
• Lead Sponsor: The Cooper Health System

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?

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-17
• Study First Submitted QC: 2025-06-25
• Last Update Submitted: 2025-06-25
• Study First Posted: 2025-06-27
• Last Update Posted: 2025-06-27
• Study Start: 2025-07-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Successful EVD catheter placement	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.
rate of complication during placement	During procedure

Secondary Outcome Measures

Name	Time	Method
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
rate of EVD replacement or revision	During procedure
rate of EVD associated hemorrhage	from placement to removal of EVD and assessed up to two weeks after
rate if EVD-associated infection	from placement to removal of EVD and assessed up to two weeks after

Trial Locations

Locations (1)

Cooper University Health; 🇺🇸 Camden, New Jersey, United States