The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant that is deployed in a mildly invasive, neuro-interventional procedure. The eShunt® Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
This is a prospective, multi-center, open label, pilot study of the eShunt® System. The study population consists of patients with post-aneurysmal subarachnoid hemorrhage (SAH) treated for increased intracranial pressure (ICP) resulting in symptomatic hydrocephalus using an external ventricular drain (EVD) to facilitate CSF drainage and who cannot be "weaned" from the EVD after the hemorrhagic event. After completion of the procedure to place the eShunt® device, the ICP will be monitored and recorded for up to 48 hours. Subjects will then return for follow-up visits that include standard neurological evaluations at 30, 60, 90, 180, and 365 days postimplantation; imaging will also be acquired at 30, 90 and 365 days after implant. Subjects will continue to attend follow-up visits every 180 days thereafter until the study is closed or up to 5 years post-implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
The eShunt® Implant is intended to drain excess cerebrospinal fluid from the intracranial subarachnoid space to the venous system as a less invasive therapy for treating hydrocephalus.
Yale University
New Haven, Connecticut, United States
Montefiore Medical Center Department of Neurosurgery
New York, New York, United States
Reduction in ICP
At 24 to 48 hours after eShunt Implant deployment (with EVD remaining clamped) an ICP measurement that indicates: * ICP below 20 cmH2O with no periods longer than 15 minutes above 20 cmH2O * No episodes of ICP above 25 cmH2O with associated symptoms
Time frame: 24-48 hours after eShunt Implant placement
Occurrence of Serious Adverse Events
The number of device and/or procedure-related serious adverse events (SAEs) after the implant procedure will be calculated.
Time frame: 90 days post procedure
Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline.
Clinically significant changes from baseline CT images will be summarized
Time frame: 1 year post procedure
Number of participants with clinically significant changes in physical and neurologic examination assessments from baseline
Clinically significant changes from baseline physical examination and neurologic examination assessments will be summarized
Time frame: 1 year post procedure
Summary of Adverse Events
Tabulation of all Adverse Events collected in the study.
Time frame: 90 days post procedure and at study completion
Changes in Modified Rankin Scale Scores
Changes in Modified Rankin Scale scores from baseline will be summarized.
Time frame: 1 year post procedure
Number of subjects requiring conversion to conventional CSF shunt
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Evaluate the need for CSF diversion by conventional CSF shunt insertion within 12 months after eShunt Implant deployment
Time frame: 1 year post procedure