NCT05250505

Brief 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 subarachnoid space (SAS) into the venous system.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
47mo left

Started Mar 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Mar 2022Apr 2030

First Submitted

Initial submission to the registry

February 11, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

March 10, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2025

Completed
4.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

February 11, 2022

Last Update Submit

March 16, 2026

Conditions

HydrocephalusHydrocephalus, Normal Pressure

Keywords

eShuntMinimally invasive shuntEndovascular shunt

Outcome Measures

Primary Outcomes (1)

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

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

    90 days following eShunt Implant deployment

Secondary Outcomes (10)

  • Number of participants with abnormal MRI findings

    90 days following eShunt Implant deployment

  • Number of participants with abnormal CT findings

    90 days following eShunt Implant deployment

  • 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 blood chemistry results

    90, 180 and 365 days following eShunt Implant deployment

  • Number of participants with clinically significant abnormal neurological exam findings

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

  • +5 more secondary outcomes

Study Arms (1)

Treatment Arm

EXPERIMENTAL

The Treatment Arm receives the eShunt Implant.

Device: eShunt Implant

Interventions

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.

Treatment Arm

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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%
  • 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

You may not qualify if:

  • 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
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica La Sagrada Familia

Buenos Aires, Ciudad A. de Buenos Aires, C1426B, Argentina

Location

Related Publications (8)

  • 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.

    PMID: 30626626BACKGROUND

  • 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.

    PMID: 34862267BACKGROUND

  • 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.

    PMID: 24518764BACKGROUND

  • 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.

    PMID: 32196732BACKGROUND

  • 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.

    PMID: 15817019BACKGROUND

  • 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.

    PMID: 32595883BACKGROUND

  • 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 Feb 24:jnis-2025-024702. doi: 10.1136/jnis-2025-024702. Online ahead of print.

    PMID: 41734937DERIVED

  • 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.

    PMID: 40135887DERIVED

MeSH Terms

Conditions

Hydrocephalus, Normal PressureHydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Pedro Lylyk, MD

    Clínica La Sagrada Familia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single group assignment
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2022

First Posted

February 22, 2022

Study Start

March 10, 2022

Primary Completion

April 23, 2025

Study Completion (Estimated)

April 1, 2030

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)