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New brain drain device could help older adults walk better

NCT ID NCT06498960

Disease control Sponsor: CereVasc Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the eShunt System for treating normal pressure hydrocephalus, a condition that causes trouble walking, thinking, and bladder control in older adults. The device drains extra fluid from the brain through a small tube. Researchers will compare it to the standard treatment (VP shunt) in 230 people aged 60 and older. The main goal is to see if walking improves after 6 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
eShunt System (a device that drains fluid from the brain)
What this could lead to
If successful, this device could offer a less invasive alternative to standard shunts, improving walking and daily function in older adults with normal pressure hydrocephalus.
What could go wrong
This is a pivotal trial, but results are not yet available. The device may not improve symptoms as hoped, and risks include infection, bleeding, or device malfunction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 230 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

normal pressure hydrocephalus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Normal pressure hydrocephalus

Contacts and locations

Locations

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Albany Medical Center

    Albany, New York, 12208, United States

  • Baptist Medical Center - Jacksonville

    Jacksonville, Florida, 32207, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Clinica La Sagrada Familia

    Buenos Aires, C1426B, Argentina

  • Cooper Neurological Institute

    Camden, New Jersey, 08103, United States

  • Henry Ford Health

    West Bloomfield, Michigan, 48322, United States

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029, United States

  • Indiana University

    Indianapolis, Indiana, 46202, United States

  • Lenox Hill Hospital

    New York, New York, 10075, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Montefiore Medical Center

    The Bronx, New York, 10467, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • St. Michael's Hospital

    Toronto, Ontario, M5C 2W6, Canada

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University at Buffalo Neurosurgery

    Buffalo, New York, 14203, United States

  • University of Calgary - Foothills Medical Centre

    Calgary, Alberta, T2N 4N1, Canada

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of Kentucky Research Foundation

    Lexington, Kentucky, 40506, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Virginia Commonwealth University

    Richmond, Virginia, 23298, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

  • Yale University

    New Haven, Connecticut, 06511, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.