What side effects are associated with this type of intervention?

Common treatments for hydrocephalus, such as ventriculoperitoneal (VP) shunts, ventriculoatrial (VA) shunts, and lumboperitoneal (LP) shunts, can have side effects including infection, shunt malfunction or blockage, over-drainage or under-drainage of cerebrospinal fluid (CSF), and surgical complications. For minimally invasive systems like the eShunt® System, potential side effects may include bleeding, infection, and device malfunction related to the neuro-interventional procedure.

What prior FDA approvals exist?

The treatment of hydrocephalus has traditionally involved the use of shunt systems, which divert cerebrospinal fluid (CSF) from the brain's ventricles to other parts of the body where it can be absorbed. Commonly used shunt systems include the ventriculoperitoneal (VP) shunt, ventriculoatrial (VA) shunt, and lumboperitoneal (LP) shunt. These systems have been approved by the FDA and are widely used in clinical practice. The eShunt® System represents a novel approach by shunting CSF from the intracranial subarachnoid space to the venous system, potentially offering a minimally invasive alternative to traditional shunt systems.

What other types of research exist?

Promising novel alternatives to the eShunt® System for hydrocephalus treatment include endoscopic third ventriculostomy (ETV) with choroid plexus cauterization (CPC), which is a minimally invasive procedure that creates a bypass for cerebrospinal fluid (CSF) flow. Another potential alternative is the use of programmable shunt valves that allow for non-invasive adjustments to CSF drainage. Additionally, advancements in bioengineered shunt materials and anti-siphon devices are being explored to improve the safety and efficacy of hydrocephalus management.

← Back to Search

Shunt System

eShunt Implant for Normal Pressure Hydrocephalus

N/A

Recruiting

Research Sponsored by CereVasc Inc

Eligibility Criteria Checklist

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

Must have

Clinical presentation consistent with NPH including 2 or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with: Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index >0.3) and the absence of severe hippocampal atrophy

Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12

Must not have

Active systemic infection or infection detected in CSF

Occlusion or stenosis of the internal jugular vein

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90, 180 and 365 days following eshunt implant deployment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new device called the eShunt System for patients with normal pressure hydrocephalus. The device helps drain extra fluid from the brain to the veins, which can improve symptoms like walking difficulties, memory issues, and bladder control problems.

Who is the study for?

This trial is for people aged 65-85 with normal pressure hydrocephalus, who have trouble walking and thinking clearly, and sometimes can't control their bladder. They should be able to get an MRI or CT scan that shows they're a good fit for the eShunt implant and have had some improvement after a spinal tap test.

What is being tested?

The study tests the eShunt System, which includes placing a permanent implant in the brain through a minimally invasive procedure. It aims to drain excess fluid into the venous system to ease symptoms like gait disturbances, cognitive issues, and urinary problems.

What are the potential side effects?

Potential side effects may include infection risks due to surgery, possible bleeding or blood clotting issues related to device placement, reactions to heparin (a medication used during surgery), or complications from incorrect fluid drainage.

Eligibility Criteria

Inclusion Criteria

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

Select...

I show signs of NPH with issues in walking, thinking, or bladder control and my MRI shows specific brain changes.

Select...

My cognitive function score is 12 or higher.

Select...

I am between 65-85 years old and need a CSF shunt for my diagnosed normal pressure hydrocephalus.

Select...

I have symptoms like walking problems, mental decline, and issues controlling my bladder.

Select...

My walking improved by at least 20% after a spinal tap test.

Select...

I have had trouble walking for at least 6 months.

Exclusion Criteria

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

Select...

I currently have an infection in my body or in my brain/spinal fluid.

Select...

I have a blockage in my internal jugular vein.

Select...

I have not had a stroke or mini-stroke in the last 6 months.

Select...

My doctor noticed swelling in the veins of my neck during an exam.

Select...

My heart scan shows a hole in the wall between its upper chambers.

Select...

I cannot walk 33 feet even with help.

Select...

I have had surgery or procedures for water on the brain.

Select...

I am allergic to heparin or contrast dyes and cannot be treated for it.

Select...

I have a blood clot above my knee.

Select...

I am experiencing symptoms of fluid buildup in my brain.

Select...

I have a tumor or mass in the back part of my brain.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90, 180 and 365 days following eshunt implant deployment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90, 180 and 365 days following eshunt implant deployment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90, 180 and 365 days following eshunt implant deployment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Device and/or procedure-related serious adverse events (SAEs)

Secondary study objectives

Change in Modified Rankin Scale compared to baseline

Change in cognitive ability compared to baseline

Body Weight Changes

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

The Treatment Arm receives the eShunt Implant.

0 / 17Eligibility 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 eShunt® System treats hydrocephalus by shunting cerebrospinal fluid (CSF) from the intracranial subarachnoid space to the venous system, thereby reducing intracranial pressure. This mechanism is crucial for hydrocephalus patients as it alleviates symptoms such as gait disturbances, cognitive dysfunction, and urinary incontinence, which are caused by the accumulation of excess CSF. By effectively managing CSF levels, the eShunt® System can significantly improve the quality of life for patients suffering from hydrocephalus.