What side effects are associated with this type of intervention?

Common treatments for External Ventricular Drain (EVD) placement, including the AxiEM Stealth image guidance method, aim to improve the accuracy of catheter placement. The primary side effects of EVD placement include infection, hemorrhage, and catheter malfunction or occlusion. Infection can occur at the insertion site or within the central nervous system. Hemorrhage may result from vessel injury during catheter insertion. Catheter malfunction or occlusion can lead to inadequate cerebrospinal fluid drainage, necessitating repositioning or replacement of the catheter. The AxiEM Stealth method, by improving placement accuracy, may reduce the risk of these complications, but the general risks associated with EVD placement still apply.

What prior FDA approvals exist?

The FDA has approved various devices and methods aimed at improving the accuracy of External Ventricular Drain (EVD) placement. These include image-guided systems that utilize CT or MRI to register patient anatomy, similar to the AxiEM Stealth image guidance system. These technologies enhance the precision of catheter placement, reducing complications and improving outcomes by providing real-time anatomical visualization during the procedure.

What other types of research exist?

Promising novel alternatives to AxiEM Stealth image guidance for EVD placement include augmented reality (AR) and stereotactic (STX) methods. These techniques have shown improved accuracy in targeting and trajectory alignment compared to conventional freehand methods. AR, in particular, offers real-time visualization and guidance, which can enhance precision during the procedure.

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Procedure

Stealth-Guided EVD Placement for Intracranial Hypertension

N/A

Recruiting

Led By Azam Ahmed, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18 years and ≤ 88 years

Be older than 18 years old

Must not have

Patients ≤ 18 and ≥ 88 years of age

Subjects who decline participation into the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial compares traditional freehand placement of brain catheters with a new method using the AxiEM Stealth image guidance system. The goal is to see if using detailed images from CT or MRI scans can help doctors place the catheters more accurately and safely in patients with conditions like hydrocephalus or brain trauma.

Who is the study for?

This trial is for adults aged 18 to 88 needing an external ventricular drain (EVD) placed, as decided by their doctor. They must be able to give consent or have a family member who can, and have a Stealth-compatible head CT or MRI. It's not for minors, prisoners, those at high medical risk as determined by the physician, emergency EVD placements without standard consent, pregnant women, or non-English speakers.

What is being tested?

The study compares traditional freehand placement of EVDs at the bedside with AxiEM Stealth image guidance—a method that uses patient-specific facial and scalp anatomy registered to CT or MRI images—to see if it improves accuracy and reduces complications.

What are the potential side effects?

While specific side effects are not listed for this procedure-based trial, potential risks may include discomfort at the insertion site, infection risk from catheter placement, possible damage to surrounding brain tissue during insertion and inaccurate placement leading to ineffective drainage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 88 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am between 18 and 88 years old.

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I do not wish to participate in the study.

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I had an emergency procedure to drain fluid from my brain.

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I or my legal representative can give consent.

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I do not speak English.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 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

Accuracy of catheter tip compared to foramen of Monro

Catheter device

Secondary study objectives

Durability of EVD

Infection rate

New neurological deficits

+2 more

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: Axium Stealth Image GuidanceExperimental Treatment2 Interventions

The novelty of this study is to investigate whether using image guidance technology can improve EVD catheter placement. Image guidance is used very commonly for EVD and shunt placement in the operating room with excellent accuracy and precision. We hypothesize that using this same workflow at the bedside will improve accuracy; decrease the number of passes needed for a successful placement, decrease the number of post-placement hemorrhagic events, and help improve the effectiveness of the catheter as well as patient outcomes.

Group II: EVD placementActive Control1 Intervention

Catheter placement is most commonly performed via a freehand approach using external anatomical landmarks to help identify the location of the lateral ventricle within the brain without the aid of imaging. Proper identification of the ventricles on pre-procedure imaging, surgeon skill, and estimation of pathologic perturbations to the normal location of the ventricles all factor into the success of catheter placement. Multiple passes are often required. The accuracy rate from the freehand technique has been reported to range from 40 to 98 percent.

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The AxiEM Stealth image guidance system enhances the accuracy of External Ventricular Drain (EVD) placement by using CT or MRI scans registered to the patient's facial and scalp anatomy. This method allows for precise localization of the lateral ventricles, reducing the risk of complications such as catheter misplacement, occlusion, or damage to brain structures. Accurate EVD placement is crucial for effective cerebrospinal fluid drainage and minimizing patient morbidity, especially in cases where traditional freehand techniques may be less reliable due to altered intracranial anatomy from trauma or pathology.

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