Recruiting soon
PEARL

Augmented Reality Assisted Ventricular Drain Placement Clinical Trial

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
Study AimThis study uses augmented reality to assist with ventricular drain placement and evaluates the success of the procedure and rate of complications.
What is being tested

EVD placement - image-guidance assisted

+ EVD placement - AR assisted
Device
Who is being recruted

ICH - Intracerebral Hemorrhage

+ IVH- Intraventricular Hemorrhage
+ TBI Traumatic Brain Injury
Over 18 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional
Study Start: July 2025

See protocol details

Summary

Principal SponsorThe Cooper Health System
Study ContactCorey Mossop, MD
Last updated: June 27, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: July 1, 2025Actual 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.

Official TitlePlacing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization: A Randomized Controlled Clinical Trial (PEARL) 
Principal SponsorThe Cooper Health System
Study ContactCorey Mossop, MD
Last updated: June 27, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
50 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
ICH - Intracerebral Hemorrhage
IVH- Intraventricular Hemorrhage
TBI Traumatic Brain Injury
Criteria
6 inclusion criteria required to participate
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
issue 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

Show More Criteria

3 exclusion criteria prevent from participating
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.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Placement of EVDs using augmented reality device
Group II
Active Comparator
Placement of EVDs using Stealth image-guidance
Study Objectives
Primary Objectives

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.

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
Suspended
Cooper University HealthCamden, United StatesSee the location
Recruiting soonOne Study Center