Brief Title
US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
Official Title
US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus
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 10 subjects will receive the eShunt Implant at up to three investigational sites. It is
anticipated that up to 45 patients may need to be enrolled (consented) in order to result in
10 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.
Study Type
Interventional
Primary Outcome
Device and/or procedure-related serious adverse events (SAEs)
Secondary Outcome
Number of participants with abnormal MRI findings
Condition
Hydrocephalus, Normal Pressure
Intervention
eShunt Implant
Study Arms / Comparison Groups
Treatment Arm
Description: The Treatment Arm receives the eShunt Implant.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
10
Start Date
April 20, 2022
Completion Date
May 1, 2027
Primary Completion Date
August 1, 2022
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 ≥10 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
Gender
All
Ages
65 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
, 5129947597, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT05232838
Organization ID
CLIN-0016
Responsible Party
Sponsor
Study Sponsor
CereVasc Inc
Collaborators
AlvaMed, Inc.
Study Sponsor
, ,
Verification Date
July 2022