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Evaluating a new treatment for normal pressure hydrocephalus

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

Not applicable Interventional CereVasc Inc · NCT06498960

This study is testing a new device called the eShunt System to see if it can help people with normal pressure hydrocephalus improve their walking and thinking skills compared to a traditional treatment.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment230 (estimated)
Ages60 Years and up
SexAll
SponsorCereVasc Inc Industry-sponsored
Locations31 sites (Los Angeles, California and 30 other locations)
Trial IDNCT06498960 on ClinicalTrials.gov

What this trial studies

This study is a prospective, multi-center, randomized, controlled trial assessing the safety and effectiveness of the CereVasc eShunt System in treating patients with normal pressure hydrocephalus (NPH). Participants will be evaluated based on their clinical presentation and MRI findings, and will receive either the eShunt System or a traditional VP shunt. The study aims to determine if the eShunt System can improve symptoms related to gait impairment and cognitive function in this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients aged 60 and older with a clinical diagnosis of normal pressure hydrocephalus and evidence of gait impairment.

Not a fit: Patients without gait impairment or those with severe cognitive decline may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve mobility and cognitive function in patients suffering from normal pressure hydrocephalus.

How similar studies have performed: Other studies have explored treatments for normal pressure hydrocephalus, but the eShunt System represents a novel approach that has not been widely tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

Each subject must meet the following criteria:

1. Patients ≥60 years old on the day of study informed consent
2. Patient or legally authorized representative is able and willing to provide written informed consent
3. History or evidence of gait impairment with a duration ≥3 months
4. Clinical presentation consistent with NPH including two or more of the clinical triad (i.e., history of gait disturbance, progressive mental deterioration, and urinary urgency or incontinence), together with all of the following:

   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. Patient is willing and able to attend all scheduled visits and comply with study procedures.
6. Confirmation of anatomy suitable for the eShunt procedure, as determined by evaluation of pre-procedure imaging (CT and MRI) and approved by an independent anatomical screening committee.

Exclusion Criteria:

Each subject may not:

1. Be unable to walk 10 meters (33 feet) with or without an assistive device
2. Be diagnosed with obstructive hydrocephalus
3. Have an active systemic infection or infection detected in CSF
4. Have had prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
5. Demonstrate hypersensitivity or contraindication to heparin or radiographic contrast agents against which the subject cannot be adequately pre-medicated, desensitized or where no alternative is available
6. Have occlusion or stenosis of the internal jugular vein which would prohibit access to the IPS
7. Present with venous distension in the neck on physical exam
8. Have medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arteriovenous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
9. Have history of bleeding diatheses, coagulopathy or refuse to consent for blood transfusion in cases of emergency
10. Have had an ischemic stroke or transient ischemic attack within 180 days of eShunt procedure
11. Have documented evidence of a deep vein thrombosis superior to the popliteal vein
12. Have intrinsic blood clotting disorder
13. Have medical conditions requiring anticoagulation which is unable to be managed to allow for surgical procedure
14. Have presence of a posterior fossa tumor or mass
15. Have a life expectancy \<1 year
16. Be currently participating in another interventional (drug, device, etc.) research project that may confound the results of this study.
17. Have established diagnosis of neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, or Lewy body dementia
18. Be diagnosed with schizophrenia or any psychiatric diagnosis (including depression) that may complicate outcome evaluation
19. Need an intracranial neurosurgical procedure within 180 days of study index procedure
20. Be unwilling or unable to comply with follow-up requirements
21. Have mRS of 0, 5, or 6

Where this trial is running

Los Angeles, California and 30 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Normal Pressure Hydrocephalus
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.