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HydrocephalusNCT05501002

Pilot Study to Evaluate the CereVasc® EShunt® System in the Treatment of Communicating Hydrocephalus

A study testing eShunt® Implant in people with Hydrocephalus and Hydrocephalus, Communicating, run by CereVasc Inc at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Hydrocephalus, Hydrocephalus, Communicating
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
4 participants
Where
2 sitesUnited States
Study dates
15 Sep 2022to 15 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 18Show fewer
  • 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
  • Currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up
  • Pregnant
  • Unwilling or unable to comply with follow-up requirements

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Yale University

    New Haven, Connecticut, 06511

  • Montefiore Medical Center Department of Neurosurgery

    New York, New York, 10467

Other trials in United States

About this study

Official title: US Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc® EShunt® System in the Treatment of Communicating Hydrocephalus

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.

Read the detailed description

This is a prospective, multi-center, open label, pilot study of the eShunt® System. The study population consists of patients with post-aneurysmal subarachnoid hemorrhage (SAH) treated for increased intracranial pressure (ICP) resulting in symptomatic hydrocephalus using an external ventricular drain (EVD) to facilitate CSF drainage and who cannot be "weaned" from the EVD after the hemorrhagic event.

After completion of the procedure to place the eShunt® device, the ICP will be monitored and recorded for up to 48 hours. Subjects will then return for follow-up visits that include standard neurological evaluations at 30, 60, 90, 180, and 365 days postimplantation; imaging will also be acquired at 30, 90 and 365 days after implant. Subjects will continue to attend follow-up visits every 180 days thereafter until the study is closed or up to 5 years post-implantation.

Being tested
eShunt® Implant
Keywords
eShunt, Endovascular Shunt
Medical subject headings
Hydrocephalus

What participants receive

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

  • eShunt® ImplantDevice

    Also called eShunt®, eShunt® system

    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.

Study groups in NCT05501002
Study groupRoleWhat they receive
Device ArmExperimentalThe Device 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. 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

    Measured: 24-48 hours after eShunt Implant placement

Secondary outcomes (6)

  1. Occurrence of Serious Adverse Events

    The number of device and/or procedure-related serious adverse events (SAEs) after the implant procedure will be calculated.

    Measured: 90 days post procedure

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

    Clinically significant changes from baseline CT images will be summarized

    Measured: 1 year post procedure

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

    Clinically significant changes from baseline physical examination and neurologic examination assessments will be summarized

    Measured: 1 year post procedure

  4. Summary of Adverse Events

    Tabulation of all Adverse Events collected in the study.

    Measured: 90 days post procedure and at study completion

  5. Changes in Modified Rankin Scale Scores

    Changes in Modified Rankin Scale scores from baseline will be summarized.

    Measured: 1 year post procedure

  6. Number of subjects requiring conversion to conventional CSF shunt

    Evaluate the need for CSF diversion by conventional CSF shunt insertion within 12 months after eShunt Implant deployment

    Measured: 1 year post procedure

Timeline

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

  1. First posted15 Aug 2022
  2. Study start15 Sep 2022
  3. Primary completion15 Sep 2023
  4. Study completion15 Sep 2023

Why it stopped: Low enrollment

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
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501002
Sponsor's protocol ID
CLIN-0029
Status last verified
Nov 2024
First submitted
12 Aug 2022
Last updated
22 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing eShunt® Implant in people with Hydrocephalus and Hydrocephalus, Communicating, run by CereVasc Inc at 2 sites in United States.

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 11 inclusion and 18 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: stopped early, as of the sponsor's last update on 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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?

The study was stopped early (reason given: Low enrollment). Results are not available in the source record.

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?

Reduction in ICP (time frame: 24-48 hours after eShunt Implant placement). 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 NCT05501002, which also lists 2 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 22 Nov 2024.

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