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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
Study 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.Check my eligibility
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.See study design
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study Feasibility
Secondary outcome measures
Accuracy of external ventricular drain (EVD) placement
Complications
Number of attempts
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
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Who is running the clinical trial?
Hamilton Health Sciences CorporationLead Sponsor
368 Previous Clinical Trials
300,953 Total Patients Enrolled
Dr. Kesava ReddyPrincipal InvestigatorHamilton Health Sciences Corporation
1 Previous Clinical Trials
40 Total Patients Enrolled
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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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment accept elderly participants?
"This trial is open to individuals who are aged 18 years and above, yet no older than a hundred."
Answered by AI
Are there any opportunities for individuals to participate in this clinical trial currently?
"The information provided by clinicaltrials.gov attests that this trial is not accepting new patients at the moment, having been first published on January 1st 2023 and last updated November 24th 2022. Nevertheless, one alternative medical study is currently recruiting participants to its program."
Answered by AI
Do I qualify to partake in this investigation?
"This research is taking on 40 people with external ventricular drains between the ages of 18 and 100. To be eligible a patient must meet certain prerequisites, such as possession an EVD and availability to provide consent (written or verbal). Moreover, they should possess a recent head CT scan that can be used for comparison purposes."
Answered by AI
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