Hydrocephalus, CommunicatingETCHES INCT04758611
The ETCHES I Study (Endovascular Treatment of Communicating Hydrocephalus With an Endovascular Shunt)
A study testing eShunt™ Implant in people with Hydrocephalus, Communicating and Hydrocephalus, run by CereVasc Inc at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hydrocephalus, Communicating, 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
- 20 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Oct 2020to 7 Jan 2028
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
- Presence of a deep vein thrombosis superior to the popliteal segment of the femoral vein
- International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 secs.)
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Clínica La Sagrada Familia
Buenos Aires, Ciudad A. de Buenos Aires, C1426B
About this study
Official title: Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt™ System in the Treatment of Communicating Hydrocephalus
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.
Read the detailed description
This is a prospective, single-center, open label, single-arm 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 following the hemorrhagic event.
The study will be performed a single site with up to 30 subjects who meet the inclusion and exclusion criteria for the study. Subjects will be evaluated every 30 days for the first 90 days following eShunt Implant deployment with standard neurological evaluation appropriate for patients with communicating hydrocephalus. In addition, follow-up will occur at 180 days, 12 and 24 months post-operatively and will include imaging in addition to the standard neurological evaluation.
- Conditions
- Hydrocephalus, Communicating, Hydrocephalus
- Being tested
- eShunt™ Implant
- Keywords
- eShunt
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | The 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.
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
Measured: 36-48 hours following eShunt Implant deployment
Secondary outcomes (4)
Number of subjects requiring conversion to conventional CSF shunt
Evaluate the need for CSF diversion by conventional CSF shunt insertion within the 24 months following eShunt Implant deployment
Measured: 24 months following eShunt Implant deployment
Incidence of clinically significant abnormal laboratory test results
Clinically significant changes from baseline laboratory test results will be summarized
Measured: 24 months following eShunt Implant deployment
Incidence of clinically significant changes from baseline MRI imaging
Clinically significant changes from baseline MRI images will be summarized
Measured: 24 months following eShunt Implant deployment
Incidence of clinically significant changes from baseline CT imaging
Clinically significant changes from baseline CT images will be summarized
Measured: 24 months 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.
- First posted17 Feb 2021
- Study start1 Oct 2020
- Primary completion7 Jan 2026
- Study completion7 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus, CommunicatingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prospective, single-center, open-label, single-arm pilot study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- CereVasc Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AlvaMed, Inc., Bioscience Consulting, Inc., Simplified Clinical Data Systems, LLC
- Responsible party
- Sponsor
- Investigators
- Pedro M Lylyk, MD, Principal investigator, Clinica Sagrada Familia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758611
- Sponsor's protocol ID
- CLIN-0001
- Acronym
- ETCHES I
- Status last verified
- Mar 2026
- First submitted
- 9 Feb 2021
- 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 30626626Lylyk 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 34862267Amllay 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Evaluate the Safety and Effectiveness of the CereVasc eShunt™ System in the Treatment of Communicating Hydrocephalus
- ClinicalTrials.gov ID
- NCT04758611
- Acronym / sponsor ID
- ETCHES I / CLIN-0001
- Conditions
- Hydrocephalus, Communicating, Hydrocephalus
- Keywords
- eShunt
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- CereVasc IncIndustry (pharma, biotech, devices)
- Collaborators
- AlvaMed, Inc., Bioscience Consulting, Inc., Simplified Clinical Data Systems, LLC
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 7 Jan 2026 (actual)
- Study completion
- 7 Jan 2028 (estimated)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-center, open label, single-arm 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 following the hemorrhagic event.
The study will be performed a single site with up to 30 subjects who meet the inclusion and exclusion criteria for the study. Subjects will be evaluated every 30 days for the first 90 days following eShunt Implant deployment with standard neurological evaluation appropriate for patients with communicating hydrocephalus. In addition, follow-up will occur at 180 days, 12 and 24 months post-operatively and will include imaging in addition to the standard neurological evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, open-label, single-arm pilot study
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Device: eShunt™ ImplantThe Treatment Arm receives the eShunt implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Clinical signs and symptoms of communicating hydrocephalus
- Neurologically stable without evidence of severe vasospasm
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eShunt™ ImplantAlso: eShunt™, eShunt™ SystemThe 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. | Device | Treatment Arm |
Primary outcome
Reduction in intracranial pressure (ICP)
Time frame: 36-48 hours following eShunt Implant deployment
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
4 secondary outcomes
Number of subjects requiring conversion to conventional CSF shunt
Time frame: 24 months following eShunt Implant deployment
Incidence of clinically significant abnormal laboratory test results
Time frame: 24 months following eShunt Implant deployment
Incidence of clinically significant changes from baseline MRI imaging
Time frame: 24 months following eShunt Implant deployment
Incidence of clinically significant changes from baseline CT imaging
Time frame: 24 months following eShunt Implant deployment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Background: PubMed 30626626Heilman 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.
- Results publication: PubMed 34862267Lylyk 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.
- Derived from this study: PubMed 40135887Amllay 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro M Lylyk, MD principal investigator
Clinica Sagrada Familia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eShunt™ Implant in people with Hydrocephalus, Communicating 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 17 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?
Reduction in intracranial pressure (ICP) (time frame: 36-48 hours 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 NCT04758611, which also lists 3 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.