Your session is about to expire
← Back to Search
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical signs and symptoms of communicating hydrocephalus
Patient is ≥ 21 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year post procedure
Awards & highlights
Study Summary
This trial will study a new, minimally invasive way to treat hydrocephalus in adults. The eShunt® System includes a delivery system and an implant that is deployed in a neuro-interventional procedure. The implant is designed to drain excess cerebrospinal fluid from the intracranial subarachnoid space into the venous system.
Who is the study for?
Adults over 21 with communicating hydrocephalus, showing clinical signs and suitable for the eShunt® procedure based on MRI and CT scans. Excluded are those with blood in CSF, obstructive hydrocephalus, infections, prior treatments for hydrocephalus, certain allergies or vein issues, life expectancy under a year, pregnancy, or inability to follow up.Check my eligibility
What is being tested?
The trial is testing the eShunt® System's ability to drain excess cerebrospinal fluid from the brain into the venous system using a minimally invasive method. It involves implanting an eShunt device through neuro-interventional procedures.See study design
What are the potential side effects?
Potential side effects may include reactions related to implantation such as infection risk at the site of surgery, bleeding complications due to heparin use (a medication that prevents clotting), contrast agent reactions if allergic or sensitive.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I show signs of fluid buildup in my brain.
Select...
I am 21 years old or older.
Select...
I had a brain bleed due to an aneurysm, needed a temporary drain for over a week, and now require a permanent drain.
Select...
My brain's blood vessels are stable without severe narrowing.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year post procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year post procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in ICP
Secondary outcome measures
Changes in Modified Rankin Scale Scores
Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline.
Number of participants with clinically significant changes in physical and neurologic examination assessments from baseline
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Device ArmExperimental Treatment1 Intervention
The Device Arm receives the eShunt® Implant
Find a Location
Who is running the clinical trial?
CereVasc IncLead Sponsor
3 Previous Clinical Trials
90 Total Patients Enrolled
3 Trials studying Hydrocephalus
90 Patients Enrolled for Hydrocephalus
AlvaMed, Inc.Industry Sponsor
3 Previous Clinical Trials
90 Total Patients Enrolled
3 Trials studying Hydrocephalus
90 Patients Enrolled for Hydrocephalus
Bioscience Consulting, Inc.Industry Sponsor
3 Previous Clinical Trials
75 Total Patients Enrolled
2 Trials studying Hydrocephalus
60 Patients Enrolled for Hydrocephalus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My brain's blood vessels are stable without severe narrowing.I have a blockage in my internal jugular vein.I show signs of fluid buildup in my brain.I have had surgery or procedures for water on the brain.There is visible blood in your cerebrospinal fluid.I am experiencing symptoms of fluid buildup in my brain.I do not have an active infection in my body or brain.I am allergic to heparin or contrast dyes and cannot be treated for it.I have a tumor or mass in the back part of my brain.You are expected to live for less than 1 year.My heart scan shows a hole in the wall between its upper chambers.I have not had a stroke or mini-stroke in the last 6 months.I am 21 years old or older.I had a brain bleed due to an aneurysm, needed a temporary drain for over a week, and now require a permanent drain.My doctor noticed swelling in the veins of my neck during an exam.I have a blood clot above my knee.I have a condition causing long-term increased neck vein pressure.Your blood clotting test results are not in the normal range.
Research Study Groups:
This trial has the following groups:- Group 1: Device 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research participants are contributing to this investigation?
"Affirmative. Clinicaltrials.gov reports that this trial was first uploaded on September 15th 2022 and is actively recruiting potential participants. A total of 10 patients are needed for the study, which will take place at one site only."
Answered by AI
Who else is applying?
What state do they live in?
California
Connecticut
What site did they apply to?
Yale University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger