Ireland
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Active, not recruiting Not applicable

US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

NCT05232838 · tracked via the Priya Life Science USA tracker
Sponsor
CereVasc Inc
Phase
Not applicable
Started
2022-04-20
Last updated
2025-06-19

Condition(s) studied

Hydrocephalus, Normal PressureHydrocephalus

Investigational drug(s) / intervention(s)

eShunt Implant

eShunt Implant: The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.

Study summary

The eShunt® System is a minimally invasive method of treating communicating hydrocephalus. The eShunt System includes a proprietary eShunt Delivery System and the eShunt Implant, a permanent implant deployed in a minimally invasive, neuro-interventional procedure. The eShunt System is intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system for the treatment of patients with normal pressure hydrocephalus, reducing disability due to symptoms including one or more of gait disturbance, cognitive dysfunction and urinary incontinence.

Eligibility

Sex
ALL
Min age
65 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation 2. Patient or legally authorized representative is able and willing to provide written informed consent 3. History or evidence of gait impairment duration ≥6 months 4. 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: 1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy 2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20% 3. CSF opening pressure ≥8 cmH2O 4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12 5. Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by subject screening committee (SSC) 6. Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC Exclusion Criteria: 1. Unable to walk 10 meters (33 feet) with or without an assistive device 2. Signs or symptoms of obstructive hydrocephalus 3. Active systemic infection or infection detected in CSF 4. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus 5. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available 6. Occlusion or stenosis of the internal jugular vein 7. Venous distension in the neck on physical exam 8. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram 9. History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency 10. Stroke or transient ischemic attack within 180 days of eShunt Procedure 11. Presence of a deep vein thrombosis superior to the popliteal vein 12. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds) 13. Presence of a posterior fossa tumor or mass 14. Life expectancy \< 1 year 15. Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up 16. Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation 17. Unwilling or unable to comply with follow-up requirements

Primary outcome measure(s)

  • Device and/or procedure-related serious adverse events (SAEs) — 90 days following eShunt Implant deployment
    Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

Trial sites (11)

FacilityCityRegionStatus
Yale University New Haven Connecticut
Baptist Health Jacksonville Florida
University of Kansas Medical Center Kansas City Kansas
University of Kentucky Research Foundation Lexington Kentucky
Beth Israel Deaconess Medical Center Boston Massachusetts
University at Buffalo, Buffalo New York
NYU Langone Health New York New York
University of Rochester Medical Center Rochester New York
Montefiore Medical Center The Bronx New York
Rhode Island Hospital Providence Rhode Island
Virginia Commonwealth University Richmond Virginia
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05232838 on ClinicalTrials.gov ↗ ← All trials in the USA