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

ConditionsICH - Intracerebral HemorrhageIVH- Intraventricular HemorrhageTBI Traumatic Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Cooper Health System

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patient at time of screening

diagnosis of spontaneous ICH with IVH with severe TBI

admitted to Cooper University Health

requires an EVD

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Augmented Reality AssistanceExperimental treatment 1 intervention
Group B: Stealth Image-guided assistanceActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
During procedure
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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cooper Health System

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: