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 Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
This is a prospective, single-center, open label, single-arm 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 following the hemorrhagic event. The study will be performed a single site with up to 30 subjects who meet the inclusion and exclusion criteria for the study. Subjects will be evaluated every 30 days for the first 90 days following eShunt Implant deployment with standard neurological evaluation appropriate for patients with communicating hydrocephalus. In addition, follow-up will occur at 180 days, 12 and 24 months post-operatively and will include imaging in addition to the standard neurological evaluation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The eShunt™ Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system as a minimally invasive treatment for communicating hydrocephalus.
Clínica La Sagrada Familia
Buenos Aires, Ciudad A. de Buenos Aires, Argentina
RECRUITINGReduction in intracranial pressure (ICP)
At 36-48 hours following eShunt Implant deployment and with EVD remaining clamped, an ICP assessment that demonstrates: 1) ICP below 20 cmH2O as measured by the EVD with no periods longer than 15 minutes above 20 cmH2O; and 2) No episodes of ICP, measured by EVD, above 25 cmH2O with associated subject symptoms
Time frame: 36-48 hours following eShunt Implant deployment
Number of subjects requiring conversion to conventional CSF shunt
Evaluate the need for CSF diversion by conventional CSF shunt insertion within the 24 months following eShunt Implant deployment
Time frame: 24 months following eShunt Implant deployment
Incidence of clinically significant abnormal laboratory test results
Clinically significant changes from baseline laboratory test results will be summarized
Time frame: 24 months following eShunt Implant deployment
Incidence of clinically significant changes from baseline MRI imaging
Clinically significant changes from baseline MRI images will be summarized
Time frame: 24 months following eShunt Implant deployment
Incidence of clinically significant changes from baseline CT imaging
Clinically significant changes from baseline CT images will be summarized
Time frame: 24 months following eShunt Implant deployment
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