US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus
NCT ID: NCT05232838
Last Updated: 2025-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2022-04-20
2030-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
The Treatment Arm receives the eShunt Implant.
eShunt 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.
Interventions
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eShunt 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.
Eligibility Criteria
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Inclusion Criteria
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
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
65 Years
85 Years
ALL
No
Sponsors
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AlvaMed, Inc.
INDUSTRY
Simplified Clinical Data Systems, LLC
INDUSTRY
CereVasc Inc
INDUSTRY
Responsible Party
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Locations
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Yale University
New Haven, Connecticut, United States
Baptist Health
Jacksonville, Florida, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Kentucky Research Foundation
Lexington, Kentucky, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University at Buffalo,
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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References
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Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9.
Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3.
Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8.
Welk B, Lenherr S, Elliott S, Stoffel J, Gomes CM, de Bessa J, Cintra LKL, Myers JB; Neurogenic Bladder Research Group. The creation and validation of a short form of the Neurogenic Bladder Symptom Score. Neurourol Urodyn. 2020 Apr;39(4):1162-1169. doi: 10.1002/nau.24336. Epub 2020 Mar 20.
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
Amllay A, Matouk CC. A Paradigm Shift in Hydrocephalus Management: The Promise of Endovascular Cerebrospinal Fluid Diversion. Cardiol Rev. 2025 Jul-Aug 01;33(4):294-297. doi: 10.1097/CRD.0000000000000886. Epub 2025 Mar 26.
Other Identifiers
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CLIN-0016
Identifier Type: -
Identifier Source: org_study_id
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