External Ventricular Drain (EVD)NCT05639036
Image Guided EVD Placement
A study testing Image Guided External Ventricular Drain Placement Using the NAV3 System and Free Hand External Ventricular Drain Placement in people with External Ventricular Drain (EVD) and Image Guidance, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- External Ventricular Drain (EVD), Image Guidance
- What is being tested?
- Image Guided External Ventricular Drain Placement Using the NAV3 System and Free Hand External Ventricular Drain Placement
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients requiring EVD placement
- patients who can safely and reasonably be randomized to either study arm
- patients with available pre-procedural head CT
- written/verbal consent obtained
Who cannot join
- patients with very small ventricles/distorted ventricular anatomy from traumatic brain injury (ie it is not reasonable to randomize the patient)
- scenarios where the EVD must be inserted immediately and there is not time to obtain consent
- scenarios where bedside image guidance system (NAV3) is unavailable
- subjects medically or neurologically unstable to obtain pre-EVD CT scan
- EVD revisions on ipsilateral side during same admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Image-guided External Ventricular Drain Placement Trial: a Prospective Randomized-controlled Trial Pilot
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.
Read the 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 injury/accident. 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.
- Conditions
- External Ventricular Drain (EVD), Image Guidance
- Being tested
- Image Guided External Ventricular Drain Placement Using the NAV3 System, Free Hand External Ventricular Drain Placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image Guided External Ventricular Drain Placement Using the NAV3 SystemDevice
Nav3 image guidance system used to assist with external ventricular drain placement
Free Hand External Ventricular Drain PlacementProcedure or surgery
External ventricular drain will be placed with the standard free-hand technique
| Study group | Role | What they receive |
|---|---|---|
| Control-Free Hand External Ventricular Drain Placement | Active comparator | This group will receive an external ventricular drain placed using the standard free-hand technique Receives: Procedure: Free Hand External Ventricular Drain Placement |
| Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System | Experimental | This group will receive an external ventricular drain placed using the assistance of the Stryker NAV3 image guidance system Receives: Device: Image Guided External Ventricular Drain Placement Using the NAV3 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility
Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence)
Measured: 8 months
Secondary outcomes (3)
Accuracy of external ventricular drain (EVD) placement
Use of Kakarla grading system. This system uses a scale of 1 to 3, with 1 being optimal/satisfactory EVD placement, 2 being suboptimal EVD placement with the tip being placed in non-eloquent tissue, and 3 being suboptimal EVD placement with the tip being placed in eloquent tissue.
Measured: 8 months
Number of attempts
Number of attempts required to satisfactorily place the EVD
Measured: 8 months
Complications
Occurrence of any complications or infections will be monitored
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Why it stopped: Limited resources available. Study unable to begin.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for External Ventricular Drain (EVD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Kesava Reddy, Principal investigator, Hamilton Health Sciences Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639036
- Sponsor's protocol ID
- 15534
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2022
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers. De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.
Publications
Kakarla UK, Kim LJ, Chang SW, Theodore N, Spetzler RF. Safety and accuracy of bedside external ventricular drain placement. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS162-6; discussion ONS166-7. doi: 10.1227/01.neu.0000335031.23521.d0.
PubMed 18728595Aljoghaiman M, Bergen B, Takroni R, Wang B, Eangles P, Farrokhyar F, Sharma S. Image-Guided versus Freehand Ventricular Drain Insertion: Systematic Review and Meta-analysis. World Neurosurg. 2022 Apr;160:85-93.e5. doi: 10.1016/j.wneu.2022.01.036. Epub 2022 Jan 13.
PubMed 35033689
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-guided External Ventricular Drain Placement Trial: a Prospective Randomized-controlled Trial Pilot
- ClinicalTrials.gov ID
- NCT05639036
- Acronym / sponsor ID
- 15534
- Conditions
- External Ventricular Drain (EVD), Image Guidance
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Limited resources available. Study unable to begin.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 injury/accident. 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Free Hand External Ventricular Drain Placement | Active comparator | Procedure: Free Hand External Ventricular Drain PlacementThis group will receive an external ventricular drain placed using the standard free-hand technique |
| Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System | Experimental | Device: Image Guided External Ventricular Drain Placement Using the NAV3 SystemThis group will receive an external ventricular drain placed using the assistance of the Stryker NAV3 image guidance system |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients requiring EVD placement
- patients who can safely and reasonably be randomized to either study arm
- patients with available pre-procedural head CT
- written/verbal consent obtained
Key exclusion criteria (5 listed)
- patients with very small ventricles/distorted ventricular anatomy from traumatic brain injury (ie it is not reasonable to randomize the patient)
- scenarios where the EVD must be inserted immediately and there is not time to obtain consent
- scenarios where bedside image guidance system (NAV3) is unavailable
- subjects medically or neurologically unstable to obtain pre-EVD CT scan
- EVD revisions on ipsilateral side during same admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Image Guided External Ventricular Drain Placement Using the NAV3 SystemNav3 image guidance system used to assist with external ventricular drain placement | Device | Intervention - Image Guided External Ventricular Drain Placement Using the NAV3 System |
| Free Hand External Ventricular Drain PlacementExternal ventricular drain will be placed with the standard free-hand technique | Procedure or surgery | Control-Free Hand External Ventricular Drain Placement |
Primary outcome
Study Feasibility
Time frame: 8 months
Patient recruitment rate (patients/month), eligibility of patients (included/excluded), unexpected events (rate of occurrence)
3 secondary outcomes
Accuracy of external ventricular drain (EVD) placement
Time frame: 8 months
Number of attempts
Time frame: 8 months
Complications
Time frame: 8 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Background: PubMed 18728595Kakarla UK, Kim LJ, Chang SW, Theodore N, Spetzler RF. Safety and accuracy of bedside external ventricular drain placement. Neurosurgery. 2008 Jul;63(1 Suppl 1):ONS162-6; discussion ONS166-7. doi: 10.1227/01.neu.0000335031.23521.d0.
- Background: PubMed 35033689Aljoghaiman M, Bergen B, Takroni R, Wang B, Eangles P, Farrokhyar F, Sharma S. Image-Guided versus Freehand Ventricular Drain Insertion: Systematic Review and Meta-analysis. World Neurosurg. 2022 Apr;160:85-93.e5. doi: 10.1016/j.wneu.2022.01.036. Epub 2022 Jan 13.
- Individual participant dataSharing planned: No. Patient data will be de-identified and the data will be analyzed as a whole before becoming available to other researchers. De-identified IPD may be shared with other researchers if necessary based on occurrence of adverse events occurrence, circumstantial findings, etc.
Related trials for External Ventricular Drain (EVD)
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Not yet recruiting
Placing External Ventricular Drains Using Assistive Augmented Reality or Image-Based Localization
ICH - Intracerebral Hemorrhage, IVH- Intraventricular Hemorrhage
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Kesava Reddy principal investigator
Hamilton Health Sciences Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image Guided External Ventricular Drain Placement Using the NAV3 System and Free Hand External Ventricular Drain Placement in people with External Ventricular Drain (EVD) and Image Guidance, run by Hamilton Health Sciences Corporation at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study Feasibility (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639036, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.