Image-Guided EVD Placement for Brain Conditions

Recruiting in Palo Alto (17 mi)

Overseen by Dr. Kesava Reddy

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Hamilton Health Sciences Corporation

No Placebo Group

Trial Summary

What is the purpose of this trial?

To determine if use of the Stryker Nav3 image guidance system offers superior results in external ventricular drain (EVD) placement compared to the standard free-hand technique.

Research Team

Dr. Kesava Reddy

Principal Investigator

Hamilton Health Sciences Corporation

Eligibility Criteria

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

I've had adjustments to my brain drain on the same side during this hospital stay.

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

Treatment Details

Interventions

• Free Hand External Ventricular Drain Placement (Procedure)
• Image Guided External Ventricular Drain Placement Using the NAV3 System (Device)

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.

Participant Groups

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+

Dr. Craig A. VanHelder

Hamilton Health Sciences Corporation

Chief Medical Officer since 2023

MD

Tracey MacArthur

Hamilton Health Sciences Corporation

Chief Executive Officer

MSc in Quality Improvement & Patient Safety from the University of Toronto, Honours BA in Psychology from the University of Waterloo, Masters Certificate in Project Management from the Schulich School of Business at York University