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

Running, not enrolling · Not applicable

Conditions studied: Hydrocephalus, Normal Pressure, Hydrocephalus

In brief

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.

Key facts

Study ID

NCT05232838

Run by

CereVasc Inc

People needed

50

Starts

2022-04-20

Expected to finish

2030-06-30

Last updated by the study team

2025-06-19

Who can join

Age: 65 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation
• Patient or legally authorized representative 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 or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
• CSF opening pressure ≥8 cmH2O
• Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
• 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)
• Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC

You may not qualify if…

• Unable to walk 10 meters (33 feet) with or without an assistive device
• 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
• Venous distension in the neck on physical exam
• Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
• History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
• Stroke or transient ischemic attack within 180 days of eShunt Procedure
• Presence of a deep vein thrombosis superior to the popliteal vein
• International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
• Presence of a posterior fossa tumor or mass
• Life expectancy < 1 year
• Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
• Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
• Unwilling or unable to comply with follow-up requirements

Where it is running

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

Full record on ClinicalTrials.gov

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