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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 belowSelect...
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
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment ArmExperimental Treatment1 Intervention
The Treatment Arm receives the eShunt Implant.
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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have an infection in my body or in my brain/spinal fluid.I have not had a stroke or mini-stroke in the last 6 months.I show signs of NPH with issues in walking, thinking, or bladder control and my MRI shows specific brain changes.My doctor noticed swelling in the veins of my neck during an exam.My cognitive function score is 12 or higher.You have a history of bleeding problems or a condition that affects blood clotting, and you won't accept a blood transfusion in an emergency.My heart scan shows a hole in the wall between its upper chambers.You are expected to live less than 1 year.I have symptoms like walking problems, mental decline, and issues controlling my bladder.I cannot walk 33 feet even with help.I have had surgery or procedures for water on the brain.Your spinal fluid pressure is too high.I am between 65-85 years old and need a CSF shunt for my diagnosed normal pressure hydrocephalus.I have a blockage in my internal jugular vein.Your blood clotting tests show results outside the normal range.I don't have any illnesses that would stop me from following the study rules.My walking improved by at least 20% after a spinal tap test.I am allergic to heparin or contrast dyes and cannot be treated for it.I have a blood clot above my knee.Your brain MRI shows ventricular enlargement that is more than expected, and you do not have severe hippocampal atrophy.I have had trouble walking for at least 6 months.I am experiencing symptoms of fluid buildup in my brain.I have a tumor or mass in the back part of my brain.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Hydrocephalus Patient Testimony for trial: Trial Name: NCT05232838 — N/A
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