PEARLAugmented Reality Assisted Ventricular Drain Placement Clinical Trial
This study uses augmented reality to assist with ventricular drain placement and evaluates the success of the procedure and rate of complications.
EVD placement - image-guidance assisted
+ EVD placement - AR assisted
Brain Injuries, Traumatic+12
+ Brain Diseases
+ Brain Injuries
Treatment Study
Summary
Study start date: July 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is exploring a new way to place medical tubes called external ventricular drains (EVDs) in adults who have had a serious brain injury or bleeding in the brain. Typically, EVDs are placed using imaging guidance to ensure they are positioned correctly, but this study is testing if using augmented reality technology can work just as well. This is important as augmented reality might make the procedure easier or quicker, which could improve patient care and outcomes. Participants in the study will undergo EVD placement using either standard image-guidance techniques or innovative augmented reality devices. The goal is to see if the augmented reality method matches the traditional method in terms of safety and effectiveness. By comparing the two methods, researchers hope to determine if augmented reality can be a reliable alternative, potentially offering a new option for medical professionals in treating brain injuries and bleeding.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location