ICH - Intracerebral HemorrhagePEARLNCT07042048
Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization
A study testing EVD placement - image-guidance assisted and EVD placement - AR assisted in people with ICH - Intracerebral Hemorrhage and IVH- Intraventricular Hemorrhage, run by The Cooper Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICH - Intracerebral Hemorrhage, IVH- Intraventricular Hemorrhage, TBI Traumatic Brain Injury
- What is being tested?
- EVD placement - image-guidance assisted and EVD placement - AR assisted
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Cooper University Health
Camden, New Jersey, 08103
Corey Mossop, MD, 856-342-2000, mossop-corey@cooperhealth.edu
About this study
Official title: Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization: A Randomized Controlled Clinical Trial (PEARL)
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?
- Conditions
- ICH - Intracerebral Hemorrhage, IVH- Intraventricular Hemorrhage, TBI Traumatic Brain Injury
- Being tested
- EVD placement - image-guidance assisted, EVD placement - AR assisted
- Keywords
- EVD, Augmented Reality, TBI, ICH, Image Guidance
- Medical subject headings
- Cerebral Hemorrhage, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVD placement - image-guidance assistedDevice
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 assistedDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality Assistance | Experimental | Placement of EVDs using augmented reality device Receives: Device: EVD placement - AR assisted |
| Stealth Image-guided assistance | Active comparator | Placement of EVDs using Stealth image-guidance Receives: Device: EVD placement - image-guidance assisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During procedure
rate of complication during placement
Measured: During procedure
Secondary outcomes (8)
rate of catheter tip dispositions
Measured: During procedure
number of passes for placement
Measured: During procedure
rate of AR or Stealth overlay failures on first try
Measured: During procedure
rate of EVD failure
Measured: from placement to removal of EVD and assessed up to two weeks after
EVD dislodgment of occlusion
Measured: from placement to removal of EVD and assessed up to two weeks after
rate of EVD replacement or revision
Measured: During procedure
rate of EVD associated hemorrhage
Measured: from placement to removal of EVD and assessed up to two weeks after
rate if EVD-associated infection
Measured: from placement to removal of EVD and assessed up to two weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICH - Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cooper Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Corey Mossop, The Cooper Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07042048
- Sponsor's protocol ID
- 25-168
- Acronym
- PEARL
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization: A Randomized Controlled Clinical Trial (PEARL)
- ClinicalTrials.gov ID
- NCT07042048
- Acronym / sponsor ID
- PEARL / 25-168
- Conditions
- ICH - Intracerebral Hemorrhage, IVH- Intraventricular Hemorrhage, TBI Traumatic Brain Injury
- Keywords
- EVD, Augmented Reality, TBI, ICH, Image Guidance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Cooper Health SystemUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 27 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality Assistance | Experimental | Device: EVD placement - AR assistedPlacement of EVDs using augmented reality device |
| Stealth Image-guided assistance | Active comparator | Device: EVD placement - image-guidance assistedPlacement of EVDs using Stealth image-guidance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVD placement - image-guidance assistedDuring 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. | Device | Stealth Image-guided assistance |
| EVD placement - AR assistedDuring 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. | Device | Augmented Reality Assistance |
Primary outcome
Successful EVD catheter placement
Time frame: 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
Time frame: During procedure
8 secondary outcomes
rate of catheter tip dispositions
Time frame: During procedure
number of passes for placement
Time frame: During procedure
rate of AR or Stealth overlay failures on first try
Time frame: During procedure
rate of EVD failure
Time frame: from placement to removal of EVD and assessed up to two weeks after
EVD dislodgment of occlusion
Time frame: from placement to removal of EVD and assessed up to two weeks after
rate of EVD replacement or revision
Time frame: During procedure
rate of EVD associated hemorrhage
Time frame: from placement to removal of EVD and assessed up to two weeks after
rate if EVD-associated infection
Time frame: from placement to removal of EVD and assessed up to two weeks after
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVD placement - image-guidance assisted and EVD placement - AR assisted in people with ICH - Intracerebral Hemorrhage and IVH- Intraventricular Hemorrhage, run by The Cooper Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corey Mossop, MD (856-342-2000, mossop-corey@cooperhealth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful EVD catheter placement (time frame: During procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.