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Tiny brain implant could replace major surgery for fluid buildup

NCT ID NCT04758611

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new device called the eShunt System for people with communicating hydrocephalus, a condition where excess fluid builds up in the brain. The device is a small, permanent implant placed through a blood vessel to drain the extra fluid, avoiding the need for traditional brain surgery. The study involves 20 adults who already have a temporary drain and need a permanent solution, and it checks if the implant safely lowers pressure in the brain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

20 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age \> 18 2. Subject provides Informed Consent (IC) 3. 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: 1. Post-clamping ICP of \> 20 cmH2O for 15 min, or 2. Post-clamping ICP \> 25 cmH2O for \< 15 min with patient intolerance to EVD clamping 3. Post-clamping ICP \>15 cmH2O for 15 min with radiographic evidence of ventriculomegaly 4. Clinical signs and symptoms of communicating hydrocephalus 5. Neurologically stable without evidence of severe vasospasm 6. 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) 7. Pre-procedure CT confirmation of no obstruction preventing CPA cistern access at target implant site (e.g., petrous bone) as confirmed by SSC Exclusion Criteria: 1. Patient is in a state of unconsciousness or is unable to understand the information provided in the Informed Consent Form for this study 2. Indication of obstructive hydrocephalus 3. Presence of gross blood in CSF from EVD 4. Pregnant 5. Unwilling or unable to comply with follow up requirements 6. Active systemic infection or infection detected in CSF 7. Life expectancy \< 1 year 8. Hypersensitivity or contraindication to heparin or radiographic contrast agents which cannot be adequately pre-medicated, desensitized or where no alternative is available 9. Occlusion or stenosis of the internal jugular vein 10. Venous distension in the neck on physical exam 11. Atrial septal defect or patent foramen ovale identified on cardiac echocardiogram 12. History of bleeding diatheses, coagulopathy or will refuse blood transfusion in cases of emergency 13. Clearly antecedent stroke unrelated to post-aneurysmal SAH 14. Patient is currently participating in another investigational drug or device trial that could conflict with study data collection or follow-up 15. 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 16. Presence of a deep vein thrombosis superior to the popliteal segment of the femoral vein 17. International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) results outside of normal range (INR 0.8-1.4; PTT 25-35 secs.)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Clínica La Sagrada Familia

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

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Other studies related to the condition(s) this trial covers.