Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus (NCT05250505) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Argentina30 participantsStarted 2022-03-10
Plain-language summary
The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
Who can participate
Age range
65 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
. Patient is able and willing to provide written informed consent
. History or evidence of gait impairment duration ≥6 months
. 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
. Pre-procedure spinal tap test with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
Exclusion criteria
. Unable to walk 10 meters (33 feet) with or without an assistive device
. Conditions impairing gait that are considered to be unrelated to hydrocephalus
. Signs or symptoms of obstructive hydrocephalus
. Active systemic infection or infection detected in CSF
. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
. Occlusion or stenosis of the internal jugular vein