Tiny brain implant could replace major surgery for fluid buildup
NCT ID NCT04758611
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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20 people
The number who actually took part.
- Started
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Oct 2020
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Clínica La Sagrada Familia
Buenos Aires, Ciudad A. de Buenos Aires, C1426B, Argentina
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Radiation-Free brain imaging for kids? ultrasound may offer a safer path
- Can a Brain-Stiffness scan spot a treatable form of dementia?
- Wearable device could monitor brain shunt function from home
- Keyhole brain surgery could spare children from shunt complications
- Sticker on the skin could replace scans for shunt checks