Ignite Creation Date:
2024-05-06 @ 6:21 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05639036
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2022-11-09
Brief Title:
Image Guided EVD Placement
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Hamilton Health Sciences Corporation
Study Overview
Official Title:
Image-guided External Ventricular Drain Placement Trial a Prospective Randomized-controlled Trial Pilot
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 sometimes builds up as a result of surgery or a traumatic brain injuryaccident This is one of most commonly performed procedures in Neurosurgery and is done bedside not in the operating room Typically surgeons will use the free-hand technique to place these drains which involves relying on a CT scan which shows the structures inside of the brain and their knowledge of the anatomy of the brain and where the EVD should be placed Image-guidance systems exist which create real time imaging of the patients brain and can act like a GPS to help guide the placement of the EVD in the correct spot This trial is planned to determine if using the image guidance system does offer improved accuracy in EVD placement lowering the number of attempts required and therefore the amount of time spent placing the EVD and risk of complications and infections A pilot study will be done first using a convenience sample at the Hamilton General Hospital to determine the feasibility of running a larger scale trial in the future
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None