US Pilot Study to Evaluate the CereVasc® eShunt® System

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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