Hydrocephalus, Hydrocephalus, Normal Pressure
Conditions
Keywords
eShunt, Minimally invasive shunt, Endovascular shunt
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 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.
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. Up to 50 subjects will receive the eShunt Implant at up to 12 investigational sites. It is anticipated that up to 250 patients may need to be enrolled (consented) in order to result in 50 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.
Interventions
DEVICEeShunt Implant
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.
Sponsors
AlvaMed, Inc.
Simplified Clinical Data Systems, LLC
CereVasc Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients 65-85 years old for whom traditional CSF shunt placement is indicated based upon a diagnostic normal pressure hydrocephalus (NPH) evaluation 2. Patient or legally authorized representative is able and willing to provide written informed consent 3. History or evidence of gait impairment duration ≥6 months 4. 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: 1. Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans' Index \>0.3) and the absence of severe hippocampal atrophy 2. Pre-procedure spinal tap test or lumbar drain with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20% 3. CSF opening pressure ≥8 cmH2O 4. Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12 5. 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) 6. 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
1. Unable to walk 10 meters (33 feet) with or without an assistive device 2. Signs or symptoms of obstructive hydrocephalus 3. Active systemic infection or infection detected in CSF 4. Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus 5. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available 6. Occlusion or stenosis of the internal jugular vein 7. Venous distension in the neck on physical exam 8. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram 9. History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency 10. Stroke or transient ischemic attack within 180 days of eShunt Procedure 11. Presence of a deep vein thrombosis superior to the popliteal vein 12. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds) 13. Presence of a posterior fossa tumor or mass 14. Life expectancy \< 1 year 15. Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up 16. Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation 17. Unwilling or unable to comply with follow-up requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device and/or procedure-related serious adverse events (SAEs) | 90 days following eShunt Implant deployment | Rate of occurrence of device and/or procedure-related serious adverse events (SAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with abnormal CT findings | 90 days following eShunt Implant deployment | Number of participants with abnormal CT findings and descriptive summaries of findings |
| Number of participants with clinically significant abnormal complete blood count (CBC) results | 90, 180, and 365 days following eShunt Implant deployment | Number of participants with clinically significant abnormal results and descriptive summaries of CBC results |
| Number of participants with clinically significant abnormal blood chemistry results | 90, 180, and 365 days following eShunt Implant deployment | Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results |
| Number of participants with clinically significant abnormal neurological exam findings | 90, 180, and 365 days following eShunt Implant deployment and at study completion | Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam findings |
| Number of participants with abnormal MRI findings | 90 days following eShunt Implant deployment | Number of participants with abnormal MRI findings and descriptive summaries of findings |
| Change in gait compared to baseline | 90, 180 and 365 days following eShunt Implant deployment | Change in gait compared to baseline as measured by the duration in seconds of the Timed Up and Go Test (shorter durations indicate improvement (increased mobility)) |
| Change in cognitive ability compared to baseline | 90, 180 and 365 days following eShunt Implant deployment | Change in cognitive ability compared to baseline as measured by Montreal Cognitive Assessment (MoCA) scores (scores range from 0-30; higher scores indicate improvement (less cognitive disability)) |
| Change in urinary symptoms compared to baseline | 90, 180 and 365 days following eShunt Implant deployment | Change in urinary symptoms compared to baseline as measured by the Neurogenic Bladder Symptom Score (NBSS) (scores range from 0-28; lower scores indicate improvement (fewer symptoms)) |
| Change in Modified Rankin Scale compared to baseline | 90, 180 and 365 days following eShunt Implant deployment | Change in degree of disability compared to baseline as measured by Modified Rankin Scale (mRS) scores (scores range from 0-6; lower scores indicate improvement (less disability)) |
| Number of participants with adverse events | 90, 180 and 365 days following eShunt Implant deployment and at study completion | Tabulation of all adverse events |
Countries
United States
Outcome results
None listed