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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 months
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
339,889 Total Patients Enrolled
Dr. Kesava ReddyPrincipal InvestigatorHamilton Health Sciences Corporation
1 Previous Clinical Trials
40 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had adjustments to my brain drain on the same side during this hospital stay.I can be safely placed in any part of the study.
Research Study Groups:
This trial has the following groups:- Group 1: Control-Free Hand External Ventricular Drain Placement
- Group 2: Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.