Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization
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
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
Treatments tested in this trial
- EVD placement - image-guidance assisted
- EVD placement - AR assisted
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov