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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial is testing a new minimally invasive method of treating hydrocephalus by shunting cerebrospinal fluid from the brain to the venous system.

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.Check my eligibility

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.See study design

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

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

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My cognitive function score is 12 or higher.

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

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

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

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I have had trouble walking for at least 6 months.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in Modified Rankin Scale compared to baseline

Change in cognitive ability compared to baseline

Body Weight Changes

+7 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

The Treatment Arm receives the eShunt Implant.

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

AlvaMed, Inc.UNKNOWN

3 Previous Clinical Trials

64 Total Patients Enrolled

3 Trials studying Hydrocephalus

64 Patients Enrolled for Hydrocephalus

CereVasc IncLead Sponsor

3 Previous Clinical Trials

64 Total Patients Enrolled

3 Trials studying Hydrocephalus

64 Patients Enrolled for Hydrocephalus

Simplified Clinical Data Systems, LLCIndustry Sponsor

6 Previous Clinical Trials

154 Total Patients Enrolled

3 Trials studying Hydrocephalus

64 Patients Enrolled for Hydrocephalus

Media Library

eShunt Implant (Shunt System) Clinical Trial Eligibility Overview. Trial Name: NCT05232838 — N/A

Hydrocephalus Research Study Groups: Treatment Arm

Hydrocephalus Clinical Trial 2023: eShunt Implant Highlights & Side Effects. Trial Name: NCT05232838 — N/A

eShunt Implant (Shunt System) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05232838 — N/A

Hydrocephalus Patient Testimony for trial: Trial Name: NCT05232838 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current enrollment for this research project?

"Affirmative. According to clinicaltrials.gov, this research project is actively seeking participants and was initially posted on April 20th 2022 with the most recent update being November 21st of the same year. The goal is to gather 10 patients from 3 separate locations for evaluation in this trial."

Answered by AI

Am I a suitable candidate for participating in this experiment?

"To be considered for the trial, candidates should have hydrocephalus and lie between 65 to 85 years of age. The team is interested in enrolling around 10 individuals into this study."

Answered by AI

Is this medical experiment accepting participants of all ages, including those under 30?

"As indicated by the study's eligibility requirements, applicants must be at least 65 years old and not exceed 85."

Answered by AI

Are there any unfilled vacancies for volunteers in this trial?

"Clinicaltrials.gov shares that this clinical trial is presently enrolling participants, with the first post dated April 20th 2022 and the most recent update recorded on November 21st 2022."

Answered by AI

Who else is applying?

What state do they live in?

California

Connecticut

What site did they apply to?

NYU Langone Health

University of Kentucky Research Foundation

Yale University

What portion of applicants met pre-screening criteria?

Met criteria

Did not meet criteria

How many prior treatments have patients received?

Why did patients apply to this trial?

My diagnosis is very recent and seeing that your procedure is less intrusive than the traditional surgery is very appealing.

PatientReceived 2+ prior treatments

I have researched this minimally invasive procedure, and tend to prefer this to shunt procedure. I can’t find anyone in Indiana that does the eShunt.

PatientReceived no prior treatments

I have had difficulty walking and urinary incontinence. After MRI's and other testing done at Uconn Farmington, CT I was diagnosed with NPH. The Neurologist that I have been working with is Dr Prakash. At the next appointment in July she will discuss installing a Shunt.

PatientReceived no prior treatments

Both my Neurologist have decided not to have a shunt at this time. I am interested in the M. Blue Valve because of the adjustable gravitational valve system with an integrated fixed pressure differential valve. I realize I am not incontinent at this time, although I do urinate 6 or 7 times a day. I may fall under traumatic brain injury.

PatientReceived 1 prior treatment

My Neurologist and Internist feel I would be a candidate. One concussion result of a whiplash in a car accident, 2021. 2022, lost my balance on brick steps, fell hitting left-side of my head at an outdoor nursery 2022, resulting in a second concussion. Neurological evaluation, Brain imaging (3) MRI's, (1) CT with contrast. March 22, 2023, Spinal Tap. Appearance Clear and Colorless. Build up of fluid on the brain, enlargement of my ventricles. My ENT doctor diagnosed tinnitus and hearing loss in right ear. Dizziness and headaches before and after the spinal tap. Cognitive impairment or normal aging? Remembering names, trouble coming up with desired words. Walk with uncertainty now, slowly with shorter steps. Look down to avoid tripping. Problems turning.

PatientReceived 2+ prior treatments