NCT04758611

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 Implant is designed to drain 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
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Oct 2020

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 Progress77%
Oct 2020Jan 2028

Study Start

First participant enrolled

October 1, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2021

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2028

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

5.3 years

First QC Date

February 9, 2021

Last Update Submit

March 16, 2026

Conditions

Hydrocephalus, CommunicatingHydrocephalus

Keywords

eShunt

Outcome Measures

Primary Outcomes (1)

  • Reduction in intracranial pressure (ICP)

    At 36-48 hours following eShunt Implant deployment and with EVD remaining clamped, an ICP assessment that demonstrates: 1) ICP below 20 cmH2O as measured by the EVD with no periods longer than 15 minutes above 20 cmH2O; and 2) No episodes of ICP, measured by EVD, above 25 cmH2O with associated subject symptoms

    36-48 hours following eShunt Implant deployment

Secondary Outcomes (4)

  • Number of subjects requiring conversion to conventional CSF shunt

    24 months following eShunt Implant deployment

  • Incidence of clinically significant abnormal laboratory test results

    24 months following eShunt Implant deployment

  • Incidence of clinically significant changes from baseline MRI imaging

    24 months following eShunt Implant deployment

  • Incidence of clinically significant changes from baseline CT imaging

    24 months following eShunt Implant deployment

Other Outcomes (1)

  • Safety Endpoint: serious adverse events (SAEs)

    24 months following eShunt Implant deployment

Study Arms (1)

Treatment Arm

EXPERIMENTAL

The Treatment Arm receives the eShunt implant

Device: eShunt™ Implant

Interventions

eShunt™ ImplantDEVICE

The eShunt™ Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system as a minimally invasive treatment for communicating hydrocephalus.

Also known as: eShunt™, eShunt™ System
Treatment Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 18
  • Subject provides Informed Consent (IC)
  • Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place with the need for a permanent CSF shunt determined through a failed EVD clamping trial defined as:
  • Post-clamping ICP of \> 20 cmH2O for 15 min, or
  • Post-clamping ICP \> 25 cmH2O for \< 15 min with patient intolerance to EVD clamping
  • Post-clamping ICP \>15 cmH2O for 15 min with radiographic evidence of ventriculomegaly
  • Clinical signs and symptoms of communicating hydrocephalus
  • Neurologically stable without evidence of severe vasospasm
  • Pre-procedure MRI with gadolinium confirmation of IPS (inferior petrosal sinus) and CPA (cerebellopontine angle) cistern anatomy suitable for eShunt Implant deployment as confirmed by SSC (subject screening committee)
  • Pre-procedure CT confirmation of no obstruction preventing CPA cistern access at target implant site (e.g., petrous bone) as confirmed by SSC

You may not qualify if:

  • Patient is in a state of unconsciousness or is unable to understand the information provided in the Informed Consent Form for this study
  • Indication of obstructive hydrocephalus
  • Presence of gross blood in CSF from EVD
  • Pregnant
  • Unwilling or unable to comply with follow up requirements
  • Active systemic infection or infection detected in CSF
  • Life expectancy \< 1 year
  • 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
  • Clearly antecedent stroke unrelated to post-aneurysmal SAH
  • Patient is 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 as determined by the study Investigator
  • +2 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 (3)

  • 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: 34862267RESULT

  • 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

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Pedro M Lylyk, MD

    Clinica Sagrada Familia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Prospective, single-center, open-label, single-arm pilot study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 17, 2021

Study Start

October 1, 2020

Primary Completion

January 7, 2026

Study Completion (Estimated)

January 7, 2028

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)