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Hydrocephalus, Normal PressureNCT05250505

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

A study testing eShunt Implant in people with Hydrocephalus, Normal Pressure and Hydrocephalus, run by CereVasc Inc at 1 site in Argentina.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial… Read more about this study

Who is it for?
Ages 65 to 85 years
Conditions the study is for
Hydrocephalus, Normal Pressure, Hydrocephalus
What is being tested?
eShunt Implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteArgentina
Study dates
10 Mar 2022to Apr 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 85 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients 65-85 years old and traditional CSF shunt placement is indicated based upon a diagnostic NPH evaluation
  • Patient is able and willing to provide written informed consent
  • History or evidence of gait impairment duration ≥6 months
  • 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:
  • Brain MRI signs of ventricular enlargement disproportionate to cerebral atrophy (Evans Index >0.3) and the absence of severe hippocampal atrophy
  • Pre-procedure spinal tap test with subsequent gait disturbance improvement (Timed Up and Go Test) of at least 20%
Show all 10Show fewer
  • CSF opening pressure ≥10 cmH2O
  • Baseline cognitive evaluation assessed by Montreal Cognitive Assessment (MoCA) test score ≥12
  • Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC
  • Pre-procedure CT confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by SSC

Who cannot join

  • Unable to walk 10 meters (33 feet) with or without an assistive device
  • Conditions impairing gait that are considered to be unrelated to hydrocephalus
  • Signs or symptoms of obstructive hydrocephalus
  • Active systemic infection or infection detected in CSF
  • Prior or existing shunts, endoscopic third ventriculostomy, or any previous surgical intervention for hydrocephalus
  • Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available
Show all 19Show fewer
  • Occlusion or stenosis of the internal jugular vein
  • Venous distension in the neck on physical exam
  • Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram
  • History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency
  • Stroke or transient ischemic attack within 180 days of eShunt Procedure
  • Presence of a deep vein thrombosis superior to the popliteal vein
  • International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 seconds)
  • Presence of a posterior fossa tumor or mass
  • Life expectancy < 1 year
  • Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
  • Other medical illnesses that may cause the patient to be non-compliant with the protocol or confound data interpretation
  • Pregnant or planning to become pregnant
  • Unwilling or unable to comply with follow-up requirements

Trial locations and contacts

1 site in 1 country.

Argentina1 site

  • Clínica La Sagrada Familia

    Buenos Aires, Ciudad A. de Buenos Aires, C1426B

Other trials in Argentina

About this study

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

The eShunt System includes proprietary delivery componentry and the eShunt Implant, a permanent implant deployed in a minimally invasive, neurointerventional procedure. The eShunt Implant is designed to mimic the function of the arachnoid granulations by draining excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system.

Read the detailed description

This is a prospective, non-randomized, open-label, single-center, pilot study in subjects with normal pressure hydrocephalus for whom a traditional CSF shunt implant is indicated.

Up to 30 subjects will receive the eShunt Implant at one investigational site. Subjects will return for five follow-up visits in the first year and then continue to attend visits every six months for 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.

Being tested
eShunt Implant
Keywords
eShunt, Minimally invasive shunt, Endovascular shunt
Medical subject headings
Hydrocephalus, Normal Pressure, Hydrocephalus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • eShunt ImplantDevice

    The eShunt System consists of endovascular delivery componentry and a permanent implant intended to shunt cerebrospinal fluid from the intracranial subarachnoid space to the venous system in adults.

Study groups in NCT05250505
Study groupRoleWhat they receive
Treatment ArmExperimentalThe Treatment Arm receives the eShunt Implant.
Receives: Device: eShunt Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device and/or procedure-related serious adverse events (SAEs)

    Rate of occurrence of device and/or procedure-related serious adverse events (SAEs)

    Measured: 90 days following eShunt Implant deployment

Secondary outcomes (10)

  1. Number of participants with abnormal MRI findings

    Number of participants with abnormal MRI findings and descriptive summaries of findings

    Measured: 90 days following eShunt Implant deployment

  2. Number of participants with abnormal CT findings

    Number of participants with abnormal CT findings and descriptive summaries of findings

    Measured: 90 days following eShunt Implant deployment

  3. Number of participants with clinically significant abnormal complete blood count (CBC) results

    Number of participants with clinically significant abnormal results and descriptive summaries of CBC results

    Measured: 90, 180 and 365 days following eShunt Implant deployment

  4. Number of participants with clinically significant abnormal blood chemistry results

    Number of participants with clinically significant abnormal findings and descriptive summaries of blood chemistry results

    Measured: 90, 180 and 365 days following eShunt Implant deployment

  5. Number of participants with clinically significant abnormal neurological exam findings

    Number of participants with clinically significant abnormal findings and descriptive summaries of neurological exam finding

    Measured: 90, 180 and 365 days following eShunt Implant deployment and at study completion

  6. Number of participants with adverse events

    Tabulation of all adverse events

    Measured: 90, 180 and 365 days following eShunt Implant deployment and at study completion

  7. Change in gait compared to baseline

    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))

    Measured: 90, 180 and 365 days following eShunt Implant deployment

  8. Change in cognitive ability compared to baseline

    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))

    Measured: 90, 180 and 365 days following eShunt Implant deployment

  9. Change in urinary symptoms compared to baseline

    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))

    Measured: 90, 180 and 365 days following eShunt Implant deployment

  10. Change in Modified Rankin Scale compared to baseline

    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))

    Measured: 90, 180 and 365 days following eShunt Implant deployment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2022
  2. Study start10 Mar 2022
  3. Primary completion23 Apr 2025
  4. Study completionApr 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single group assignment
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05250505
Sponsor's protocol ID
CLIN-0012
Status last verified
Mar 2026
First submitted
11 Feb 2022
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Heilman CB, Basil GW, Beneduce BM, Malek AM. Anatomical characterization of the inferior petrosal sinus and adjacent cerebellopontine angle cistern for development of an endovascular transdural cerebrospinal fluid shunt. J Neurointerv Surg. 2019 Jun;11(6):598-602. doi: 10.1136/neurintsurg-2018-014445. Epub 2019 Jan 9.

    PubMed 30626626

  • Lylyk P, Lylyk I, Bleise C, Scrivano E, Lylyk PN, Beneduce B, Heilman CB, Malek AM. First-in-human endovascular treatment of hydrocephalus with a miniature biomimetic transdural shunt. J Neurointerv Surg. 2022 May;14(5):495-9. doi: 10.1136/neurintsurg-2021-018136. Epub 2021 Dec 3.

    PubMed 34862267

  • Welk B, Morrow S, Madarasz W, Baverstock R, Macnab J, Sequeira K. The validity and reliability of the neurogenic bladder symptom score. J Urol. 2014 Aug;192(2):452-7. doi: 10.1016/j.juro.2014.01.027. Epub 2014 Feb 8.

    PubMed 24518764

  • Welk B, Lenherr S, Elliott S, Stoffel J, Gomes CM, de Bessa J, Cintra LKL, Myers JB; Neurogenic Bladder Research Group. The creation and validation of a short form of the Neurogenic Bladder Symptom Score. Neurourol Urodyn. 2020 Apr;39(4):1162-1169. doi: 10.1002/nau.24336. Epub 2020 Mar 20.

    PubMed 32196732

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PubMed 15817019

  • Serrano CM, Sorbara M, Minond A, Finlay JB, Arizaga RL, Iturry M, Martinez P, Heinemann G, Gagliardi C, Serra A, Magliano FC, Yacovino D, Rojas MMEY, Ruiz AS, Graviotto HG. Validation of the Argentine version of the Montreal Cognitive Assessment Test (MOCA): A screening tool for Mild Cognitive Impairment and Mild Dementia in Elderly. Dement Neuropsychol. 2020 Apr-Jun;14(2):145-152. doi: 10.1590/1980-57642020dn14-020007.

    PubMed 32595883

  • Lylyk P, Matouk CC, Hanel RA, Reavey-Cantwell JF, Riina HA, Altschul DJ, Siddiqui AH, Fraser JF, Ebersole KC, Bhalla T, Bender MT, Ogilvy CS, Taussky P, Baker A, Jayaraman MV, Lylyk I, Perez N, Bleise C, Scrivano E, Lylyk PN, Nowicki KW, Koo AB, Antonios J, Beneduce BM, Levy EI, Heilman CB, Malek AM. Safety of endovascular shunting for normal pressure hydrocephalus from a prospective, multicenter, single-arm study. J Neurointerv Surg. 2026 Jun 17:jnis-2025-024702. doi: 10.1136/jnis-2025-024702. Online ahead of print.

    PubMed 41734937

  • Amllay A, Matouk CC. A Paradigm Shift in Hydrocephalus Management: The Promise of Endovascular Cerebrospinal Fluid Diversion. Cardiol Rev. 2025 Jul-Aug 01;33(4):294-297. doi: 10.1097/CRD.0000000000000886. Epub 2025 Mar 26.

    PubMed 40135887

Questions about this trial

What is this clinical trial studying?

A study testing eShunt Implant in people with Hydrocephalus, Normal Pressure and Hydrocephalus, run by CereVasc Inc at 1 site in Argentina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device and/or procedure-related serious adverse events (SAEs) (time frame: 90 days following eShunt Implant deployment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05250505, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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