Status:
ACTIVE_NOT_RECRUITING
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Lead Sponsor:
CereVasc Inc
Collaborating Sponsors:
AlvaMed, Inc.
Simplified Clinical Data Systems, LLC
Conditions:
Hydrocephalus, Normal Pressure
Hydrocephalus
Eligibility:
All Genders
65-85 years
Phase:
NA
Brief 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 d...
Detailed 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....
Eligibility Criteria
Inclusion
- 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
- 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
- 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
- History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
- Stroke or transient ischemic attack within 180 days of eShunt Procedure
- Presence of a deep vein thrombosis superior to the popliteal vein
- International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
- Presence of a posterior fossa tumor or mass
- Life expectancy \< 1 year
- Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
- Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
- Unwilling or unable to comply with follow-up requirements
Key Trial Info
Start Date :
April 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05232838
Start Date
April 20 2022
End Date
June 30 2030
Last Update
June 19 2025
Active Locations (11)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
Baptist Health
Jacksonville, Florida, United States, 32207
3
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
4
University of Kentucky Research Foundation
Lexington, Kentucky, United States, 40506