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

Not Applicable

Active, not recruiting

• Conditions: Hydrocephalus, Normal Pressure; Hydrocephalus
• Interventions: Device: eShunt Implant

• Registration Number: NCT05232838
• Lead Sponsor: CereVasc Inc

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 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.

Study Timeline

• Study First Submitted: 2022-01-06
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-10
• Study Start: 2022-04-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-18
• Last Update Posted: 2025-01-22
• Primary Completion: 2025-04-30
• Study Completion: 2030-04-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Arm	eShunt Implant	The Treatment Arm receives the eShunt Implant.

Primary Outcome Measures

Name	Time	Method
Device and/or procedure-related serious adverse events (SAEs)	90 days following eShunt Implant deployment	Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

Secondary Outcome Measures

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

Trial Locations

Locations (11)

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

Montefiore Medical Center; 🇺🇸 Bronx, New York, 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

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States