US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus (NCT05232838) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
United States50 participantsStarted 2022-04-20
Plain-language summary
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.
Who can participate
Age range65 Years – 85 Years
SexALL
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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:
✓. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy
✓. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
✓. CSF opening pressure ≥8 cmH2O
✓. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
✕. Unable to walk 10 meters (33 feet) with or without an assistive device
✕. Signs or symptoms of obstructive hydrocephalus
✕. Active systemic infection or infection detected in CSF
✕. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
✕. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
✕. Occlusion or stenosis of the internal jugular vein
✕. Venous distension in the neck on physical exam
✕. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram