Image-Guided EVD Placement for Brain Conditions

Overseen By Dr. Kesava Reddy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hamilton Health Sciences Corporation

Disqualifiers: Small ventricles, Traumatic brain injury, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Stryker Nav3 image guidance system improves the placement of external ventricular drains (EVDs) in the brain compared to the traditional free-hand method. EVDs relieve pressure from fluid buildup in the brain, which can occur due to various brain conditions. Participants will have their EVD placed either using the standard free-hand method or with the Nav3 system. The trial seeks individuals who need an EVD and have a head CT scan (a type of brain imaging) available before the procedure. As an unphased trial, this study offers participants the chance to contribute to advancing medical techniques for brain procedures.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Stryker Nav3 image guidance system is safe for EVD placement?

Research shows that the Stryker NAV3 image guidance system safely places external ventricular drains (EVDs). EVDs are small tubes inserted into the brain to drain fluid. Studies indicate that using image guidance for EVD placement takes no more time than the traditional free-hand method. It often requires fewer attempts to position the tube correctly, reducing the risk of complications.

No evidence suggests that image guidance causes more issues than the free-hand method. In fact, it might even help prevent problems like tube blockages. Many doctors prefer image guidance, especially in more challenging cases. Overall, data suggest that the NAV3 system is well-tolerated and safe for patients needing EVD placement. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using image-guided external ventricular drain (EVD) placement with the NAV3 System because it offers a new level of precision compared to the traditional free-hand method. Unlike the standard free-hand technique, which relies on a surgeon's experience and skill, the NAV3 System uses advanced imaging technology to guide the placement of the drain, potentially reducing the risk of complications. This could mean safer and more effective management of brain conditions that require EVD placement, leading to better patient outcomes.

What evidence suggests that the NAV3 system is effective for EVD placement?

Research has shown that using the Stryker Nav3 image guidance system for placing an external ventricular drain (EVD) is more accurate than the manual method. In this trial, participants will be assigned to one of two groups: one will receive EVD placement using the standard free-hand technique, while the other will receive EVD placement with the Stryker NAV3 image guidance system. Studies indicate that the image-guided method often requires fewer attempts and is more precise, ensuring more accurate tube placement in the brain, which can reduce complications. Additionally, using image guidance takes no more time than the traditional method. These findings suggest that image guidance might improve the overall success of EVD placement. ^{1 2 3 4 6}

Who Is on the Research Team?

Dr. Kesava Reddy

Principal Investigator

Hamilton Health Sciences Corporation

Are You a Good Fit for This Trial?

This trial is for patients who need an external ventricular drain (EVD) placed and can be safely assigned to either the image-guided or free-hand placement technique. They must have a recent head CT scan and give consent. It's not for those with very small or distorted ventricles, unstable conditions preventing a pre-EVD CT, needing immediate EVD without time for consent, or requiring ipsilateral EVD revisions.

Inclusion Criteria

Patients requiring EVD placement

Patients with available pre-procedural head CT

Written/verbal consent obtained

Exclusion Criteria

Scenarios where bedside image guidance system (NAV3) is unavailable

Patients with very small ventricles/distorted ventricular anatomy from traumatic brain injury (i.e., it is not reasonable to randomize the patient)

Scenarios where the EVD must be inserted immediately and there is not time to obtain consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive external ventricular drain placement using either the free-hand technique or the Stryker NAV3 image guidance system

8 months

Follow-up

Participants are monitored for safety, accuracy of EVD placement, number of attempts, and complications

8 months

What Are the Treatments Tested in This Trial?

Interventions

• Free Hand External Ventricular Drain Placement
• Image Guided External Ventricular Drain Placement Using the NAV3 System

Trial Overview The study compares two methods of placing an EVD: one using the Stryker Nav3 image guidance system and the other using the standard free-hand technique. The goal is to see if the NAV3 system leads to better outcomes in positioning the drain.

How Is the Trial Designed?

Group I: Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System Experimental Treatment 1 Intervention

This group will receive an external ventricular drain placed using the assistance of the Stryker NAV3 image guidance system

Group II: Control-Free Hand External Ventricular Drain Placement Active Control 1 Intervention

This group will receive an external ventricular drain placed using the standard free-hand technique

Who Is Running the Clinical Trial?

Hamilton Health Sciences Corporation

Lead Sponsor

Trials

380

Recruited

345,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05639036

NCT05639036 | Image Guided EVD Placement An external ventricular drain (EVD) is a small tube that is placed into a space in the brain called a ventricle. This is done to drain fluid in the brain that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12560684/

Comparison of Accuracy Between Image-Guided and ... Image guidance in bedside EVD placement does not require more time in comparison with freehand EVD placement and is associated with fewer passes and higher ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772529425001328

Superior accuracy of external ventricular drain placement ... The primary aim of this study was to evaluate the accuracy, complication rates, and clinical utility of EM-guided EVD placement compared to traditional ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11317059/

Augmented Reality-Guided External Ventricular Drain ... This report explores the use of a headset-based augmented reality (AR) system for guidance during the EVD placement procedure.

5. journals.lww.com journals.lww.com/neurosurgpraconline/fulltext/2024/09000/resident_opinions_on_image_guidance_for_external.12.aspx

Resident Opinions on Image Guidance for External... The majority chose to use image guidance during EVD placement for cases of narrow slit-like ventricles (86.92%) over intraventricular hemorrhage (13.08%) and ...

6. thejns.org thejns.org/view/journals/j-neurosurg/135/4/article-p1146.xml

Utility of image-guided external ventriculostomy Image-guided EVD placement was not associated with an increased likelihood of achieving optimal catheter position or with a lower rate of catheter blockage.