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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.
Full 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.
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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:
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
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
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Central trial contact
Ona Whelove
Data sourced from clinicaltrials.gov
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