Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus (NCT05250505) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Argentina30 participantsStarted 2022-03-10
Plain-language summary
The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.
Who can participate
Age range65 Years – 85 Years
SexALL
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Inclusion criteria
âś“. Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
âś“. Patient is able and willing to provide written informed consent
✓. History or evidence of gait impairment duration ≥6 months
âś“. 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:
âś“. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans Index \>0.3) and the absence of severe hippocampal atrophy
âś“. Pre-procedure spinal tap test with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
✓. CSF opening pressure ≥10 cmH2O
✓. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
Exclusion criteria
âś•. Unable to walk 10 meters (33 feet) with or without an assistive device
âś•. Conditions impairing gait that are considered to be unrelated to hydrocephalus
âś•. Signs or symptoms of obstructive hydrocephalus
âś•. Active systemic infection or infection detected in CSF
âś•. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
âś•. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
âś•. Occlusion or stenosis of the internal jugular vein
âś•. Venous distension in the neck on physical exam