NCT05501002

Brief Summary

The purpose of this study will be to evaluate a novel, minimally invasive method of treating hydrocephalus in adults. The eShunt® System includes a proprietary eShunt® Delivery System and the eShunt® Implant, a permanent implant that is deployed in a mildly 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

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

2 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

August 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 15, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 15, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

1 year

First QC Date

August 12, 2022

Last Update Submit

November 20, 2024

Conditions

HydrocephalusHydrocephalus, Communicating

Keywords

eShuntEndovascular Shunt

Outcome Measures

Primary Outcomes (1)

  • Reduction in ICP

    At 24 to 48 hours after eShunt Implant deployment (with EVD remaining clamped) an ICP measurement that indicates: * ICP below 20 cmH2O with no periods longer than 15 minutes above 20 cmH2O * No episodes of ICP above 25 cmH2O with associated symptoms

    24-48 hours after eShunt Implant placement

Secondary Outcomes (6)

  • Occurrence of Serious Adverse Events

    90 days post procedure

  • Incidence of clinically significant changes in Computed Tomography Imaging (CT/CTA) from baseline.

    1 year post procedure

  • Number of participants with clinically significant changes in physical and neurologic examination assessments from baseline

    1 year post procedure

  • Summary of Adverse Events

    90 days post procedure and at study completion

  • Changes in Modified Rankin Scale Scores

    1 year post procedure

  • +1 more secondary outcomes

Study Arms (1)

Device Arm

EXPERIMENTAL

The Device Arm receives the eShunt® Implant

Device: eShunt® Implant

Interventions

eShunt® ImplantDEVICE

The eShunt® Implant is intended to drain excess cerebrospinal fluid from the intracranial subarachnoid space to the venous system as a less invasive therapy for treating hydrocephalus.

Also known as: eShunt®, eShunt® system
Device Arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient is ≥ 21 years old
  • Patient or legally authorized representative is able and willing to provide written informed consent
  • Post-aneurysmal SAH with Hunt and Hess Grades I-IV with EVD in place for at least 7 days 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 minutes, or
  • Post-clamping ICP \> 25 cmH2O for \< 15 minutes with patient intolerance to EVD clamping, or
  • Significant radiographic signs of increasing ventriculomegaly, or
  • Neurological decline attributable to ventriculomegaly and requiring CSF diversion
  • Clinical signs and symptoms of communicating hydrocephalus
  • Neurologically stable without evidence of severe vasospasm
  • Pre-procedure MRI confirmation of anatomy suitable for eShunt Procedure, as described in Section 1.8.3.4.2 and confirmed by subject screening committee (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:

  • Presence of gross blood in CSF
  • 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
  • Medical conditions associated with prolonged elevation of jugular venous pressure, including jugular vein stenosis or stricture, right sided heart failure, cirrhosis of the liver, arterial venous fistulas in the arm for dialysis purposes, or an arterial venous fistula or malformation in the neck or brain
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University

New Haven, Connecticut, 06511, United States

Location

Montefiore Medical Center Department of Neurosurgery

New York, New York, 10467, United States

Location

Related Publications (2)

  • 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

  • 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

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

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

Study Record Dates

First Submitted

August 12, 2022

First Posted

August 15, 2022

Study Start

September 15, 2022

Primary Completion

September 15, 2023

Study Completion

September 15, 2023

Last Updated

November 22, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

US(2)