US Pilot Study of the CereVasc® eShunt® System in Normal Pressure Hydrocephalus

NCT05232838 | Active Not Recruiting DMC FDA Device

• 1 other identifier: CLIN-0016
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

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.

Conditions

Hydrocephalus, Normal Pressure; Hydrocephalus

Keywords

eShunt; Minimally invasive shunt; Endovascular shunt

Outcome Measures

Primary Outcomes (1)

• Device and/or procedure-related serious adverse events (SAEs)

  Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

  90 days following eShunt Implant deployment

Secondary Outcomes (10)

• Number of participants with abnormal MRI findings

  90 days following eShunt Implant deployment

• Number of participants with abnormal CT findings

  90 days following eShunt Implant deployment

• 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 blood chemistry results

  90, 180, and 365 days following eShunt Implant deployment

• Number of participants with clinically significant abnormal neurological exam findings

  90, 180, and 365 days following eShunt Implant deployment and at study completion

Study Arms (1)

Treatment Arm

EXPERIMENTAL

The Treatment Arm receives the eShunt Implant.

Device: eShunt Implant

Interventions

eShunt Implant DEVICE

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.

Treatment Arm

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CereVasc Inc: lead
• AlvaMed, Inc.: collaborator
• Simplified Clinical Data Systems, LLC: collaborator

Study Sites (11)

Yale University

New Haven, Connecticut, 06511, United States

Location

Baptist Health

Jacksonville, Florida, 32207, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

University of Kentucky Research Foundation

Lexington, Kentucky, 40506, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

University at Buffalo,

Buffalo, New York, 14203, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Related Publications (6)

• 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.

  PMID: 30626626 BACKGROUND

• 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.

  PMID: 34862267 BACKGROUND

• 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.

  PMID: 24518764 BACKGROUND

• 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.

  PMID: 32196732 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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.

  PMID: 40135887 DERIVED

MeSH Terms

Conditions

Hydrocephalus, Normal Pressure; Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: January 6, 2022
• First Posted: February 10, 2022
• Study Start: April 20, 2022
• Primary Completion: June 15, 2025
• Study Completion (Estimated): June 30, 2030
• Last Updated: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (11)