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.
Brief Title
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
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.
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.
Completion Date
Completion Date Type
Estimated
Conditions
Hydrocephalus, Normal Pressure
Hydrocephalus
Eligibility Criteria
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
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
Inclusion Criteria
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
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
Gender
All
Gender Based
false
Keywords
eShunt
Minimally invasive shunt
Endovascular shunt
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
65 Years
NCT Id
NCT05232838
Org Class
Industry
Org Full Name
CereVasc Inc
Org Study Id
CLIN-0016
Overall Status
Active, not recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
Primary Outcomes
Outcome Description
Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)
Outcome Measure
Device and/or procedure-related serious adverse events (SAEs)
Outcome Time Frame
90 days following eShunt Implant deployment
Secondary Outcomes
Outcome Description
Number of participants with abnormal MRI findings and descriptive summaries of findings
Outcome Time Frame
90 days following eShunt Implant deployment
Outcome Measure
Number of participants with abnormal MRI findings
Outcome Description
Number of participants with abnormal CT findings and descriptive summaries of findings
Outcome Time Frame
90 days following eShunt Implant deployment
Outcome Measure
Number of participants with abnormal CT findings
Outcome Description
Number of participants with clinically significant abnormal results and descriptive summaries of CBC results
Outcome Time Frame
90, 180, and 365 days following eShunt Implant deployment
Outcome Measure
Number of participants with clinically significant abnormal complete blood count (CBC) results
Outcome Description
Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results
Outcome Time Frame
90, 180, and 365 days following eShunt Implant deployment
Outcome Measure
Number of participants with clinically significant abnormal blood chemistry results
Outcome Description
Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam findings
Outcome Time Frame
90, 180, and 365 days following eShunt Implant deployment and at study completion
Outcome Measure
Number of participants with clinically significant abnormal neurological exam findings
Outcome Description
Tabulation of all adverse events
Outcome Time Frame
90, 180 and 365 days following eShunt Implant deployment and at study completion
Outcome Measure
Number of participants with adverse events
Outcome Description
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))
Outcome Time Frame
90, 180 and 365 days following eShunt Implant deployment
Outcome Measure
Change in gait compared to baseline
Outcome Description
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))
Outcome Time Frame
90, 180 and 365 days following eShunt Implant deployment
Outcome Measure
Change in cognitive ability compared to baseline
Outcome Description
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))
Outcome Time Frame
90, 180 and 365 days following eShunt Implant deployment
Outcome Measure
Change in urinary symptoms compared to baseline
Outcome Description
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))
Outcome Time Frame
90, 180 and 365 days following eShunt Implant deployment
Outcome Measure
Change in Modified Rankin Scale compared to baseline
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
65
Investigators
Investigator Type
Principal Investigator
Investigator Name
David Altschul
Investigator Email
daltschu@montefiore.org
Investigator Phone
718-920-7498