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.
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 50 subjects will receive the eShunt Implant at up to 12 investigational sites. It is anticipated that up to 250 patients may need to be enrolled (consented) in order to result in 50 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
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.
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
...and 1 more locations
Device and/or procedure-related serious adverse events (SAEs)
Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)
Time frame: 90 days following eShunt Implant deployment
Number of participants with abnormal MRI findings
Number of participants with abnormal MRI findings and descriptive summaries of findings
Time frame: 90 days following eShunt Implant deployment
Number of participants with abnormal CT findings
Number of participants with abnormal CT findings and descriptive summaries of findings
Time frame: 90 days following eShunt Implant deployment
Number of participants with clinically significant abnormal complete blood count (CBC) results
Number of participants with clinically significant abnormal results and descriptive summaries of CBC results
Time frame: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal blood chemistry results
Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results
Time frame: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal neurological exam findings
Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam findings
Time frame: 90, 180, and 365 days following eShunt Implant deployment and at study completion
Number of participants with adverse events
Tabulation of all adverse events
Time frame: 90, 180 and 365 days following eShunt Implant deployment and at study completion
Change in gait compared to baseline
Change in gait compared to baseline as measured by the duration in seconds of the Timed Up and Go Test (shorter durations indicate improvement (increased mobility))
Time frame: 90, 180 and 365 days following eShunt Implant deployment
Change in cognitive ability compared to baseline
Change in cognitive ability compared to baseline as measured by Montreal Cognitive Assessment (MoCA) scores (scores range from 0-30; higher scores indicate improvement (less cognitive disability))
Time frame: 90, 180 and 365 days following eShunt Implant deployment
Change in urinary symptoms compared to baseline
Change in urinary symptoms compared to baseline as measured by the Neurogenic Bladder Symptom Score (NBSS) (scores range from 0-28; lower scores indicate improvement (fewer symptoms))
Time frame: 90, 180 and 365 days following eShunt Implant deployment
Change in Modified Rankin Scale compared to baseline
Change in degree of disability compared to baseline as measured by Modified Rankin Scale (mRS) scores (scores range from 0-6; lower scores indicate improvement (less disability))
Time frame: 90, 180 and 365 days following eShunt Implant deployment
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