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

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Description

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.

Study Overview

Start Date
April 20, 2022
Completion Date
October 30, 2029
Enrollment
30
Date Posted
February 10, 2022
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Yale University
New Haven, Connecticut 06511, United States

University of Kentucky Research Foundation
Lexington, Kentucky 40506, United States

University at Buffalo,
Buffalo, New York 14203, United States

NYU Langone Health
New York, New York 10016, United States

Eligibility

Minimum Age (years)
65
Maximum Age (years)
85
Eligibility Criteria
Inclusion Criteria:

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

Exclusion Criteria:

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

Study Contact Info

Study Contact Name
Ona Whelove
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
Detailed Description
This is a prospective, non-randomized, open-label, multi-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional cerebrospinal fluid (CSF) shunt implant is indicated.

Up to 30 subjects will receive the eShunt Implant at up to 12 investigational sites. It is anticipated that up to 150 patients may need to be enrolled (consented) in order to result in 30 subjects who qualify according to the inclusion/exclusion criteria. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months until the study is closed or up to five years post-implantation.

The study objectives are to demonstrate safety of the eShunt Procedure, as well as demonstrate safety and efficacy of the eShunt Implant in a small sample of patients. Subjects will be followed long-term; primary analysis results will be used to support additional studies.
NCTid (if applicable)
NCT05232838