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

April 8, 2024 updated by: CereVasc Inc

US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® eShunt® System in the Treatment of Normal Pressure Hydrocephalus

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 30 subjects will receive the eShunt Implant at up to 12 investigational sites. It is anticipated that up to 150 patients may need to be enrolled (consented) in order to result in 30 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

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Connecticut
    • Florida
      • Jacksonville, Florida, United States, 32207
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • University of Kentucky Research Foundation
        • Contact:
        • Principal Investigator:
          • Justin F. Fraser, MD, FAANS, FAHA
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center
        • Contact:
        • Principal Investigator:
          • David Altschul, MD
      • Buffalo, New York, United States, 14203
        • Recruiting
        • University at Buffalo,
        • Principal Investigator:
          • Adnan Siddiqui, MD, PhD
        • Contact:
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
        • Principal Investigator:
          • Howard Riina, MD
      • Rochester, New York, United States, 14642
    • Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years to 83 years (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Arm
The Treatment Arm receives the eShunt Implant.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device and/or procedure-related serious adverse events (SAEs)
Time Frame: 90 days following eShunt Implant deployment
Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)
90 days following eShunt Implant deployment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with abnormal MRI findings
Time Frame: 90 days following eShunt Implant deployment
Number of participants with abnormal MRI findings and descriptive summaries of findings
90 days following eShunt Implant deployment
Number of participants with abnormal CT findings
Time Frame: 90 days following eShunt Implant deployment
Number of participants with abnormal CT findings and descriptive summaries of findings
90 days following eShunt Implant deployment
Number of participants with adverse events
Time Frame: 90, 180 and 365 days following eShunt Implant deployment and at study completion
Tabulation of all adverse events
90, 180 and 365 days following eShunt Implant deployment and at study completion
Change in gait compared to baseline
Time Frame: 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))
90, 180 and 365 days following eShunt Implant deployment
Change in cognitive ability compared to baseline
Time Frame: 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))
90, 180 and 365 days following eShunt Implant deployment
Change in urinary symptoms compared to baseline
Time Frame: 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))
90, 180 and 365 days following eShunt Implant deployment
Change in Modified Rankin Scale compared to baseline
Time Frame: 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))
90, 180 and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal complete blood count (CBC) results
Time Frame: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal results and descriptive summaries of CBC results
90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal blood chemistry results
Time Frame: 90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results
90, 180, and 365 days following eShunt Implant deployment
Number of participants with clinically significant abnormal neurological exam findings
Time Frame: 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
90, 180, and 365 days following eShunt Implant deployment and at study completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CereVasc Inc

Collaborators

AlvaMed, Inc.
Simplified Clinical Data Systems, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2022

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2029

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 10, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-0016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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