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Image-Guided EVD Placement for Brain Conditions

N/A
Waitlist Available
Led By Dr. Kesava Reddy
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 months
Awards & highlights
No Placebo-Only Group

Summary

This trial compares if a tech-aided approach to EVD placement is better than the standard manual technique.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not listed for this procedure-based trial, potential risks may include infection at the insertion site, bleeding around the brain, damage to brain tissue from incorrect placement, or malfunction of the drainage system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Study Feasibility
Secondary study objectives
Accuracy of external ventricular drain (EVD) placement
Complications
Number of attempts

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 SystemExperimental Treatment1 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 PlacementActive Control1 Intervention
This group will receive an external ventricular drain placed using the standard free-hand technique

Find a Location

Who is running the clinical trial?

Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
340,360 Total Patients Enrolled
Dr. Kesava ReddyPrincipal InvestigatorHamilton Health Sciences Corporation
1 Previous Clinical Trials
40 Total Patients Enrolled

Media Library

Free Hand External Ventricular Drain Placement Clinical Trial Eligibility Overview. Trial Name: NCT05639036 — N/A
Image-Guided Surgery Research Study Groups: Control-Free Hand External Ventricular Drain Placement, Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System
Image-Guided Surgery Clinical Trial 2023: Free Hand External Ventricular Drain Placement Highlights & Side Effects. Trial Name: NCT05639036 — N/A
Free Hand External Ventricular Drain Placement 2023 Treatment Timeline for Medical Study. Trial Name: NCT05639036 — N/A
~20 spots leftby Jun 2025
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